Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis (POETYK-PSO-1)

• ClinicalTrials.gov Identifier: NCT03624127
• Recruitment Status: Completed
• First Posted: August 9, 2018
• Results First Posted: January 30, 2023
• Last Update Posted: January 30, 2023
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Study Description

Brief Summary:

The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Drug: BMS-986165; Other: Placebo; Drug: Apremilast	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 666 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis
• Actual Study Start Date: August 7, 2018
• Actual Primary Completion Date: September 2, 2020
• Actual Study Completion Date: September 2, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: BMS-986165	Drug: BMS-986165; Specified dose on specified days
Placebo Comparator: Placebo	Other: Placebo; Specified dose on specified days
Active Comparator: Apremilast	Drug: Apremilast; Specified dose on specified days

Outcome Measures

Primary Outcome Measures :

1. The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1) [ Time Frame: Week 16 ]
   The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
2. The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75) [ Time Frame: Baseline and Week 16 ]

   PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.

   Baseline is defined as the measurement at the randomization visit (Week 0).

Secondary Outcome Measures :

1. The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score at Week 16 (PASI 90) [ Time Frame: Baseline and Week 16 ]

   PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.

   Baseline is defined as the measurement at the randomization visit (Week 0).

2. The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 100) [ Time Frame: Baseline and Week 16 ]

   PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the response as a number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.

   Baseline is defined as the measurement at the randomization visit (Week 0).

3. The Number of Participants With a Static Physician's Global Assessment Score of 0 at Week 16 (sPGA 0) [ Time Frame: Week 16 ]
   The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). sPGA 0 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
4. Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 [ Time Frame: Baseline and Week 16 ]

   PSSD is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participants-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). A symptom score will be derived by averaging the 5 questions and multiplying by 10. A sign score will be derived by averaging the 6 questions and multiplying by 10. A total PSSD score with range 0-100 will be derived from taking the average of the symptom and sign scores, where 0 representing the least severe symptom/sign and 100 the most severe. A mBOCF approach will be used for missing data.

   Baseline is defined as the measurement at the randomization visit (Week 0).

5. Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score 0 at Week 16 [ Time Frame: Week 16 ]
   PSSD with a 24-hour recall period is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participants-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). PSSD 0 is the response as a number of participants who experience a PSSD symptom score that is derived from the average of the scores and determines psoriasis severity as 0 among participants with a baseline PSSD symptom score >= 1.
6. The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1) [ Time Frame: Week 16 ]
   DLQI is a participant-reported quality of life index which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week before questionnaire. Each question is scored on a scale of 0 to 3 by a tick box (0 = "not at all"; 1 = "a little"; 2 = "a lot"; or 3 = "very much"). The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). DLQI 0/1 is the response as a number of participants who experience DLQI score of 0 or 1 among participants with a baseline DLQI score >=2.
7. Number of Participants With a Physician's Global Assessment-Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 [ Time Frame: Week 16 ]
   PGA-F overall condition of the fingernails is rated on a 5-point scale (0 = clear; 1 = minimal; 2 = mild; 3 = moderate; and 4 = severe). PGA-F 0/1 is the response as a number of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score >=3.
8. The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75) [ Time Frame: Baseline and Week 16 ]

   PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.

   Baseline is defined as the measurement at the randomization visit (Week 0).

9. The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1) [ Time Frame: Week 16 ]
   The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
10. The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1) [ Time Frame: Week 16 ]
    ss-PGA is a 5-point scale that evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness. The higher ss-PGA score denotes to more severe disease activity (0 = absence of disease; 1 = very mild disease; 2 = mild disease; 3 = moderate disease; 4 = severe disease). ss-PGA 0/1 is the response as a number of participants who experience a ss-PGA score that determines scalp lesions severity as 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score >=3.
11. The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (sPGA 0/1) [ Time Frame: Week 24 ]
    The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 24 or who have missing week 24 endpoint data for any reason.
12. The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 75) [ Time Frame: Baseline and Week 24 ]

    PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 24 or who have missing week 24 endpoint data for any reason.

    Baseline is defined as the measurement at the randomization visit (Week 0).

13. The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90) [ Time Frame: Baseline and Week 24 ]

    PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 24 or who have missing week 24 endpoint data for any reason.

    Baseline is defined as the measurement at the randomization visit (Week 0).

14. The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (sPGA 0/1) [ Time Frame: Week 52 and Week 24 ]
    The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52 or who have missing week 52 endpoint data for any reason.
15. The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (PASI 75) [ Time Frame: Baseline, Week 52 and Week 24 ]

    PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52, or who have missing week 52 endpoint data for any reason.

    Baseline is defined as the measurement at the randomization visit (Week 0).

16. The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (PASI 90) [ Time Frame: Baseline, Week 52 and Week 24 ]

    PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52, or who have missing week 52 endpoint data for any reason.

    Baseline is defined as the measurement at the randomization visit (Week 0).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Plaque psoriasis for at least 6 months
• Moderate to severe disease
• Candidate for phototherapy or systemic therapy

Exclusion Criteria:

• Other forms of psoriasis
• History of recent infection
• Prior exposure to BMS-986165 or active comparator

Other protocol defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

United States, Alabama

Achieve Clinical Research

Birmingham, Alabama, United States, 35216

Coastal Clinical Research - Mobile

Mobile, Alabama, United States, 36608

United States, Arizona

Elite Clinical Studies

Phoenix, Arizona, United States, 85018

Arizona Research Center

Phoenix, Arizona, United States, 85053

Synexus - Tucson

Tucson, Arizona, United States, 85741

United States, Arkansas

Hull Dermatology

Rogers, Arkansas, United States, 72758

United States, California

First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley

Fountain Valley, California, United States, 92708

University California at Irvine Dermatology Clinical Research Center

Irvine, California, United States, 92697

Keck School of Medicine

Los Angeles, California, United States, 90033

Dream Team Clinical Research

Pomona, California, United States, 91767

University Dermatology Group

San Diego, California, United States, 92123

Unison Clinical Trials

Sherman Oaks, California, United States, 91403

United States, Connecticut

New England Research Associates

Bridgeport, Connecticut, United States, 06606

United States, Florida

Precision Clinical Research

Davie, Florida, United States, 33328

Indago Research and Health Center

Hialeah, Florida, United States, 33012

San Marcus Research Clinic

Miami Lakes, Florida, United States, 33014

LCC Medical Research

Miami, Florida, United States, 33126

International Dermatology Research

Miami, Florida, United States, 33144

Well Pharma Medical Research

Miami, Florida, United States, 33173

Miami Dade Medical Research Institute

Miami, Florida, United States, 33176

Renstar Medical Research

Ocala, Florida, United States, 34471

Ameriderm Research

Ormond Beach, Florida, United States, 32174

Olympian Clinical Research

Tampa, Florida, United States, 33614-7118

Palm Beach Research Center

West Palm Beach, Florida, United States, 33409-3401

United States, Georgia

Hamilton Dermatology

Alpharetta, Georgia, United States, 30022

United States, Illinois

Healthcare Research Network - Flossmoor

Flossmoor, Illinois, United States, 60402

Springfield Clinic

Springfield, Illinois, United States, 62703

United States, Indiana

Deaconess Clinic Downtown

Evansville, Indiana, United States, 47708

The Dermatology Center

New Albany, Indiana, United States, 47150

The Indiana Clinical Trials Center

Plainfield, Indiana, United States, 46168

The South Bend Clinic

South Bend, Indiana, United States, 46617

United States, Kansas

Kansas City Dermatology

Overland Park, Kansas, United States, 66215

United States, Kentucky

Dermatology Specialists Research-Kentucky

Louisville, Kentucky, United States, 40241

United States, Louisiana

Clinical Trials of America - Monroe

Monroe, Louisiana, United States, 71201

Etre Cosmetic Dermatology and Laser Center

New Orleans, Louisiana, United States, 70130

United States, Massachusetts

ActivMed Practices and Research - Beverly

Beverly, Massachusetts, United States, 01915

DermCare Experts

Quincy, Massachusetts, United States, 02169

United States, Michigan

David Fivenson MD Dermatology

Ann Arbor, Michigan, United States, 48103

Somerset Skin Centre

Troy, Michigan, United States, 48084

United States, Minnesota

Associated Skin Care Specialists - Minnesota Clinical Study Center

New Brighton, Minnesota, United States, 55112

United States, Missouri

MediSearch Clinical Trials

Saint Joseph, Missouri, United States, 64506

United States, New Hampshire

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

United States, New Jersey

Hassman Research Institute

Berlin, New Jersey, United States, 08009

United States, New York

Forest Hills Dermatology Group

Kew Gardens, New York, United States, 11374

Mount Sinai - Queens

New York, New York, United States, 10023

United States, North Carolina

PMG Research of Charlotte

Charlotte, North Carolina, United States, 28209

Duke University Health System - Duke Clinic

Durham, North Carolina, United States, 27710-4000

M3 Wake Research, Inc.

Raleigh, North Carolina, United States, 27612

United States, Ohio

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43203

Synexus - Columbus

Columbus, Ohio, United States, 43212

United States, Oklahoma

Health Research of Oklahoma

Oklahoma City, Oklahoma, United States, 73103-2433

United States, Oregon

Oregon Medical Research Center

Portland, Oregon, United States, 97223-6683

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Clinical Research Center of Reading

Wyomissing, Pennsylvania, United States, 19610

United States, South Carolina

Synexus Clinical Research - Anderson

Anderson, South Carolina, United States, 29621

Clinical Research Center of the Carolinas

Charleston, South Carolina, United States, 29407

United States, Tennessee

Interspond - Stones River Dermatology - Murfreesboro Office

Murfreesboro, Tennessee, United States, 37129

United States, Texas

Westlake Dermatology - Westlake

Austin, Texas, United States, 78746

Dermatology Treatment and Research Center

Dallas, Texas, United States, 75230

Metroplex Clinical Research Center

Dallas, Texas, United States, 75231

Menter Dermatology Research Institute

Dallas, Texas, United States, 75246

Austin Institute for Clinical Research - Pflugerville

Pflugerville, Texas, United States, 78660

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States, 78218

Interspond - Acclaim Dermatology

Sugar Land, Texas, United States, 77479

Center for Clinical Studies - Webster

Webster, Texas, United States, 77598

United States, Washington

Dermatology Associates of Seattle

Seattle, Washington, United States, 98101

Eastern Washington Dermatology

Walla Walla, Washington, United States, 99362

Canada, Alberta

Kirk Barber Research

Calgary, Alberta, Canada, T2G 1B1

Canada, British Columbia

Dr. Chih-ho Hong Medical Inc.

Surrey, British Columbia, Canada, V3R 6A7

Canada, Manitoba

Wiseman Dermatology Research

Winnipeg, Manitoba, Canada, R3M 3Z4

Canada, Ontario

The Guenther Dermatology Research Centre

London, Ontario, Canada, N6A 3H7

Office of Dr. Arnon Moshe Katz

Newmarket, Ontario, Canada, L3Y 6P5

North Bay Dermatology Centre

North Bay, Ontario, Canada, P1B 3Z7

Institute of Cosmetic and Laser Surgery

Oakville, Ontario, Canada, L6J 7W5

Skin Centre for Dermatology

Peterborough, Ontario, Canada, K9J 5K2

The Centre for Dermatology - Richmond Hill

Richmond Hill, Ontario, Canada, L4B 1A5

XLR8 Medical Research

Windsor, Ontario, Canada, N8W 1E6

Canada, Quebec

Docteur David Gratton Dermatologue

Montreal, Quebec, Canada, H3H 1V4

Siena Medical Research

Montreal, Quebec, Canada, H3Z 2S6

Canada

Centre de Recherche Dermatologique du Quebec Metropolitain

Quebec, Canada, G1V 4X7

China, Beijing

Local Institution

Beijing, Beijing, China, 100050

China, Hubei

Local Institution

Wuhan, Hubei, China, 430030

China, Zhejiang

Local Institution

Hangzhou, Zhejiang, China, 310009

Germany

Charite Universitatsmedizin Berlin

Berlin, Germany, 10117

Klinische Forschung Dresden GmbH

Dresden, Germany, 01069

Japan

Local Institution - 0165

Nagoya, Aichi, Japan, 467-8602

Local Institution - 0181

Toon-Shi, Ehime, Japan, 7910295

Fukuoka University Hospital

Fukuoka-shi, Fukuoka, Japan, 814-0180

University of Occupational and Environmental Health, Japan

Kitakyushu, Fukuoka, Japan, 807-8555

Sapporo Skin Clinic

Sapporo, Hokkaido, Japan, 060-0063

Kobe University Hospital

Kobe, Hyogo, Japan, 650-0017

Local Institution - 0182

Isehara City, Kanagawa, Japan, 259-1193

National Hospital Organization Yokohama Medical Center

Yokohama-shi, Kanagawa, Japan, 2458575

Local Institution - 0169

Yokohama, Kanagawa, Japan, 236-0004

Kochi Medical School Hospital

Nakoku, Kochi, Japan, 783-8505

University Hospital - Kyoto Preferctural University of Medicine

Kyoto-city, Kyoto, Japan, 602-8566

Mie University Hospital

Tsu, MIE, Japan, 514-8507

Local Institution - 0166

Matsumoto, Nagano, Japan, 3908621

Kurashiki Central Hospital

Kurashiki, Okayama, Japan, 7108602

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan, 431-3192

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan, 329-0498

Teikyo University Hospital

Itabashi-Ku, Tokyo, Japan, 173-8606

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, Japan, 173-8610

The Jikei University Hospital

Minato-ku, Tokyo, Japan, 105-8471

Local Institution - 0188

Shinagawa, Tokyo, Japan, 141-8625

Local Institution - 0175

Shinjuku-Ku, Tokyo, Japan, 160-0023

Local Institution - 0108

Shinjuku, Tokyo, Japan, 169-0073

Kumamoto University Hospital

Kumamoto, Japan, 860-8556

Kyoto University Hospital

Kyoto, Japan, 606-8507

Local Institution - 0167

Osaka, Japan, 545-8586

Local Institution - 0160

Osaka, Japan, 550-0006

Korea, Republic of

Local Institution

Busan, Korea, Republic of, 49241

Local Institution - 0187

Hwaseong-si, Korea, Republic of, 18450

Local Institution

Hwaseong-si, Korea, Republic of, 18450

Local Institution

Incheon, Korea, Republic of, 21565

Local Institution

Seongnam-si, Korea, Republic of, 13620

Local Institution

Seoul, Korea, Republic of, 120-752

Local Institution

Seoul, Korea, Republic of, 137-701

Local Institution

Seoul, Korea, Republic of, 660-702

Poland

Local Institution - 0191

Warszawa, MZ, Poland, 02-962

Local Institution - 0201

Bialystok, Poland, 15-077

Local Institution - 0144

Gdynia, Poland, 81-537

Synexus - Katowice

Katowice, Poland, 40-040

Local Institution - 0079

Krak, Poland, 30-510

Centrum Terapii Wspolczesnej

Lodz, Poland, 90-242

Centrum Medyczne All-Med

Lodz, Poland, 94-048

Miejski Szpital Zespolony w Olsztynie

Olsztyn, Poland, 10-229

DermoDent - Centrum Medyczne Czajkowscy

Osielsko, Poland, 86-031

Solumed Centrum Medyczne

Poznan, Poland, 60-529

Local Institution - 0200

Poznan, Poland, 60-773

Clinical Research Group

Warszawa, Poland, 01-142

Center for Clinical Studies - Texas Medical Center

Wroclaw, Poland, 50-367

Lukasz Matusiak 4health

Wroclaw, Poland, 50-566

dermMedica Sp. z o.o.

Wroclaw, Poland, 51-318

Local Institution - 0203

Wroclaw, Poland, 51-685

Russian Federation

Local Institution - 0131

Ekaterinburg, Russian Federation, 620076

Azbuka Zdorovya Medical Center

Kazan, Russian Federation, 42011

Local Institution - 0172

Krasnodar, Russian Federation, 350020

Local Institution - 0140

Moscow, Russian Federation, 101000

Clinical Medical Center of Moscow State Medico-Stomatological University named after AI Evdokimov

Moscow, Russian Federation, 111398

State budgetary institution of Ryazan region - Regional Clinical Skin and Venereal Dispensary

Ryazan, Russian Federation, 390046

Clinic of Skin Diseases of Pierre Wolkenstein

Saint Petersburg, Russian Federation, 191123

Polyclinic of Private Security Personnel

Saint Petersburg, Russian Federation, 192007

Saint-Petersburg SBHI Dermatological and Venereological Dispensary No. 10 - Clinic of Dermatology

Saint Petersburg, Russian Federation, 194021

Ars Vitae Multidisciplinary Medical Center

Saint Petersburg, Russian Federation, 194223

Klinika Kozhnykh I Venericheskikh Bolezney

Saratov, Russian Federation, 410028

Smolensk State Medical University

Smolensk, Russian Federation, 214019

MUZ Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev

Yaroslavl, Russian Federation, 150003

Spain

Local Institution - 0121

Alcorcon, Spain, 28921

Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

Hospital Universitario Cruces

Barakaldo, Spain, 48903

Hospital del Mar - Parc de Salut Mar

Barcelona, Spain, 08003

Hospital Universitario La Paz

Madrid, Spain, 28046

Hospital Universitario de Fuenlabrada

Madrid, Spain, 28942

Local Institution - 0097

Valencia, Spain, 46026

Taiwan

Local Institution

Kaohsiung, Taiwan, 81362

Local Institution

Taipei, Taiwan, 10099

Local Institution

Taipei, Taiwan, 11217

United Kingdom

MAC Clinical Research - Blackpool

Lancashire, United Kingdom, FY2 0JH

Synexus - Merseyside Clinical Research Centre

Liverpool, United Kingdom, L22 0LG

Guys and Saint Thomas NHS Foundation Trust

London, United Kingdom, SE1 9RT

Synexus - Manchester Clinical Research Centre

Manchester, United Kingdom, M15 6SE

Salford Royal NHS Foundation Trust

Manchester, United Kingdom, M6 8HD

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle Upon Tyne, United Kingdom, NE1 4LP

MAC Clinical Research - Liverpool

Prescot, United Kingdom, L34 1BH

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:

Study Protocol  [PDF] December 17, 2019

Statistical Analysis Plan  [PDF] December 17, 2019

More Information

Additional Information:

BMS Clinical Trial Information 

BMS Clinical Trial Patient Recruiting 

FDA Safety Alerts and Recalls 

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03624127
• Other Study ID Numbers: IM011-046; 2018-001926-25 ( EudraCT Number )
• First Posted: August 9, 2018
• Results First Posted: January 30, 2023
• Last Update Posted: January 30, 2023
• Last Verified: January 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Apremilast; Deucravacitinib; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase 4 Inhibitors; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Protein Kinase Inhibitors