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History of Changes for Study: NCT03721172
Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy (ADVANCE)
Latest version (submitted March 1, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 24, 2018 None (earliest Version on record)
2 January 2, 2019 Study Status, Contacts/Locations, Eligibility, Oversight and Study Identification
3 March 18, 2019 Recruitment Status, Contacts/Locations and Study Status
4 March 27, 2019 Study Status and Contacts/Locations
5 April 15, 2019 Study Status and Contacts/Locations
6 April 22, 2019 Contacts/Locations and Study Status
7 May 8, 2019 Study Status and Contacts/Locations
8 May 22, 2019 Contacts/Locations and Study Status
9 June 6, 2019 Study Status and Contacts/Locations
10 June 10, 2019 Contacts/Locations and Study Status
11 July 9, 2019 Study Status and Contacts/Locations
12 August 12, 2019 Contacts/Locations and Study Status
13 August 20, 2019 Contacts/Locations and Study Status
14 September 29, 2019 Study Status and Contacts/Locations
15 October 14, 2019 Study Status and Contacts/Locations
16 January 17, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
17 February 25, 2020 Study Status
18 April 17, 2020 Study Status, Sponsor/Collaborators, Study Identification, IPDSharing and Contacts/Locations
19 August 3, 2020 Recruitment Status, Study Status, References and Contacts/Locations
20 November 4, 2020 Study Status
21 April 26, 2021 Outcome Measures, Study Status, Arms and Interventions, More Information, Document Section, Adverse Events, Baseline Characteristics, Participant Flow and Study Identification
22 July 15, 2022 Study Status and References
23 January 9, 2023 Study Status
24 March 1, 2024 Study Status and References
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Study NCT03721172
Submitted Date:  July 9, 2019 (v11)

Open or close this module Study Identification
Unique Protocol ID: CC-10004-PSOR-022
Brief Title: Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy (ADVANCE)
Official Title: A PHASE 3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, STUDY OF THE EFFICACY AND SAFETY Of APREMILAST (CC-10004), COMPARED TO PLACEBO, IN SUBJECTS WTIH MILD TO MODERATE PLAQUE PSORIASIS
Secondary IDs: U1111-1218-8372 [Registry Identifier: WHO]
Open or close this module Study Status
Record Verification: July 2019
Overall Status: Recruiting
Study Start: March 11, 2019
Primary Completion: August 5, 2020 [Anticipated]
Study Completion: December 23, 2020 [Anticipated]
First Submitted: October 9, 2018
First Submitted that
Met QC Criteria:
October 24, 2018
First Posted: October 26, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
July 9, 2019
Last Update Posted: July 11, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Celgene
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis.

Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.

Detailed Description:

The study will consist of four phases:

  • Screening Phase - up to 35 days
  • Double-blind Placebo-controlled Phase - Weeks 0 to 16

    - Subjects will be randomly assigned to either apremilast 30 mg tablets orally BID or placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID.

  • Apremilast Extension Phase - Weeks 16 to 32

    - All subjects will be switched to (or continue with) apremilast 30 mg BID. All subjects will maintain this dosing through Week 32.

  • Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue the study early.
Open or close this module Conditions
Conditions: Psoriasis
Keywords: Phase 3
Double-Blind
Efficacy
Safety
Apremilast
Otezla
CC-10004
Plaque Psoriasis
Mild
Moderate
Scalp
Nail
Itch
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 574 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Apremilast 30 mg or Placebo
Oral Apremilast 30 mg or placebo twice daily (BID) from Week 0 to Week 16
Drug: Apremilast
Apremilast, oral, twice daily
Placebo
Placebo, oral, twice daily
Experimental: Apremilast 30 mg, extension
Apremilast 30 mg twice daily (BID) from Week 16 to Week 32
Drug: Apremilast
Apremilast, oral, twice daily
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Proportion of subjects with an sPGA score of clear (0) or almost clear (1) and with at least a 2- point reduction from baseline at Week 16.
[ Time Frame: Up to week 16 ]

Static Physician Global Assessment (sPGA) 0/1
Secondary Outcome Measures:
1. Proportion of subjects who improved ≥ 75% in BSA from baseline at Week 16.
[ Time Frame: Up to week 16 ]

Body Surface Area (BSA)
2. Body Surface Area (BSA)changes
[ Time Frame: Up to week 16 ]

Change from baseline in affected BSA at Week 16.
3. Psoriasis Area and Severity Index (PASI)
[ Time Frame: Up to week 16 ]

Change from baseline in total PASI score at Week 16
4. Proportion of subjects with BSA ≤ 3%
[ Time Frame: Up to week 16 ]

Proportion of subjects who achieved BSA ≤ 3% for subjects with baseline BSA > 3% at Week 16.
5. Proportion of subjects with ≥4-point reduction (improvement) from baseline in the whole-body itch NRS score at Week 16 among subjects with baseline whole body itch NRS ≥ 4.
[ Time Frame: Up to week 16 ]

Whole body itch numeric rating scale (NRS)
6. Proportion of subjects with ScPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16 among subjects with baseline ScPGA score ≥ 2.
[ Time Frame: Up to week 16 ]

Scalp Physician Global Assessment (ScPGA)
7. Dermatology Life Quality Index (DLQI)
[ Time Frame: Up to week 16 ]

Change from baseline in DLQI total score at Week 16
8. Adverse Events (AEs)
[ Time Frame: From signed the informed consent until at least 28 days after completion of study treatment ]

An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

  1. Subject must be male or female, ≥18 years of age at the time of signing the informed consent form (ICF).
  2. Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.
  3. Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening and Baseline.
  4. Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline.
  5. Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
  6. Subject must meet laboratory criteria.
  7. Subject has not had prior exposure to biologics for the treatment of psoriatic arthritis or psoriasis, or any other condition that could impact the assessment of psoriasis.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

  1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  2. Subjects has any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.

2. Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB.

4. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).

5. Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.

6. Subject has prior history of suicide attempt at any time in the subject's life time or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 7. Subject has current or planned concurrent use of therapies that may have a possible effect on psoriasis during the course of the treatment phase of the trial.

8. Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).

9. Subject had prior treatment with apremilast.

Open or close this module Contacts/Locations
Central Contact Person: Associate Director Clinical Trial Disclosure
Telephone: 1-888-260-1599
Email: clinicaltrialdisclosure@celgene.com
Study Officials: Yao Wang, MD
Study Director
Celgene Corporation
Locations: United States, Alabama
Total Skin & Beauty Dermatology Center
[Recruiting]
Birmingham, Alabama, United States, 35205
United States, Arkansas
Johnson Dermatology Clinic
[Recruiting]
Fort Smith, Arkansas, United States, 72916
Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology
[Recruiting]
Rogers, Arkansas, United States, 72758
United States, California
Dermatology Research Associates
[Recruiting]
Los Angeles, California, United States, 90045
TCR Medical Corporation
[Recruiting]
San Diego, California, United States, 92123
University of California San Francisco Psoriasis and Skin Treatment Center
[Recruiting]
San Francisco, California, United States, 94118
Dermatology Institute and Skin Care Center
[Recruiting]
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado Hospital - Dermatology Clinic
[Not yet recruiting]
Aurora, Colorado, United States, 80045
United States, Florida
Total Vein and Skin, LLC
[Recruiting]
Boynton Beach, Florida, United States, 33437
Florida Academic Centers Research and Education
[Recruiting]
Coral Gables, Florida, United States, 33134
International Dermatology Research
[Recruiting]
Miami, Florida, United States, 33144
Center for Clinical and Cosmetic Research
[Recruiting]
Miami, Florida, United States, 33180
Renstar Medical Research
[Recruiting]
Ocala, Florida, United States, 34470
University of South Florida - Carol and Frank Morsani Center for Advanced Health Care
[Recruiting]
Tampa, Florida, United States, 33612
United States, Georgia
Atlanta Dermatology, Vein and Research Center, PC
[Recruiting]
Alpharetta, Georgia, United States, 30022
Medical Dermatology Specialists, Inc. - Advanced Medical Research
[Recruiting]
Atlanta, Georgia, United States, 30328
MedaPhase INC
[Recruiting]
Newnan, Georgia, United States, 30263
Gwinnett Clinical Research Center, Inc.
[Recruiting]
Snellville, Georgia, United States, 30078
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
[Recruiting]
Indianapolis, Indiana, United States, 46256
United States, Louisiana
Clinical Trials Management LLC
[Recruiting]
Metairie, Louisiana, United States, 70006
United States, Maryland
Derm Associates
[Recruiting]
Rockville, Maryland, United States, 20850
Lawrence Green, MD, LLC
[Recruiting]
Rockville, Maryland, United States, 20850
United States, Massachusetts
ActivMed Practices & Research Inc
[Recruiting]
Beverly, Massachusetts, United States, 01915
Massachusetts General Hospital
[Recruiting]
Boston, Massachusetts, United States, 02114-2517
United States, Michigan
Henry Ford Medical Center - New Center One
[Recruiting]
Detroit, Michigan, United States, 48202
United States, Minnesota
Minnesota Clinical Study Center
[Recruiting]
Fridley, Minnesota, United States, 55432
United States, Missouri
Central Dermatology
[Recruiting]
Saint Louis, Missouri, United States, 63117
United States, Nevada
JDR Dermatology Research, LLC
[Recruiting]
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Psoriasis Treatment Center of Central New Jersey
[Recruiting]
East Windsor, New Jersey, United States, 08520
United States, New York
Albert Einstein College of Medicine - Montefiore Medical Center
[Not yet recruiting]
Bronx, New York, United States, 10467
Icahn School of Medicine at Mount Sinai
[Recruiting]
New York, New York, United States, 10003
United States, North Carolina
University of North Carolina - Dermatology and Skin Cancer Center
[Not yet recruiting]
Chapel Hill, North Carolina, United States, 27516
Wake Forest University Health Sciences
[Not yet recruiting]
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Ohio State University Wexner Medical Center
[Recruiting]
Columbus, Ohio, United States, 43210
Wright State Physicians
[Recruiting]
Fairborn, Ohio, United States, 45324
United States, Pennsylvania
Temple University - Lewis Katz School of Medicine
[Not yet recruiting]
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh Medical Center
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Clinical Partners, LLC
[Recruiting]
Johnston, Rhode Island, United States, 02919
United States, South Carolina
Clinical Research Center of the Carolinas
[Recruiting]
Charleston, South Carolina, United States, 29407
United States, Texas
Austin Institute for Clinical Research
[Recruiting]
Pflugerville, Texas, United States, 78660
Center for Clinical Studies
[Recruiting]
Webster, Texas, United States, 77598
United States, Utah
University of Utah MidValley Dermatology
[Not yet recruiting]
Murray, Utah, United States, 84107
United States, Virginia
Virginia Clinical Research Inc
[Recruiting]
Norfolk, Virginia, United States, 23502
United States, Washington
Dermatology of Seattle
[Not yet recruiting]
Seattle, Washington, United States, 98168
United States, West Virginia
Dermatology Center for Skin Health
[Recruiting]
Morgantown, West Virginia, United States, 26505
Canada
Sameh Hanna Medicine Professional Corporation DBA Dermatology on Bloor
[Recruiting]
Toronto, Canada, M4W 2N2
Canada, Alberta
Institute for Skin Advancement
[Recruiting]
Calgary, Alberta, Canada, T3A 2N1
Stratica Medical
[Recruiting]
Edmonton, Alberta, Canada, T5K 1X3
Canada, British Columbia
Chih-Ho Hong Medical, Inc.
[Recruiting]
Surrey, British Columbia, Canada, V3R 6A7
Enverus Medical Research
[Recruiting]
Surrey, British Columbia, Canada, V3V 0C6
Canada, Manitoba
Winnipeg Clinic Dermatology Research
[Recruiting]
Winnipeg, Manitoba, Canada, R3CON2
SkinWise Dermatology
[Recruiting]
Winnipeg, Manitoba, Canada, R3M3Z4
Canada, New Brunswick
Brunswick Dermatology Centre
[Recruiting]
Fredericton, New Brunswick, Canada, E3B 1G9
Canada, Newfoundland and Labrador
Karma Clinical Trials
[Not yet recruiting]
Saint John's, Newfoundland and Labrador, Canada, A1A 4Y3
Canada, Ontario
SimcoDerm Medical and Surgical Dermatology Center
[Recruiting]
Barrie, Ontario, Canada, L4M 7G1
Guelph Dermatology Research
[Recruiting]
Guelph, Ontario, Canada, N1L 0B7
DermEffects
[Recruiting]
London, Ontario, Canada, N6H 5L5
Lynderm Research
[Recruiting]
Markham, Ontario, Canada, L3P1X2
North Bay Dermatology Centre
[Recruiting]
North Bay, Ontario, Canada, P1B 3Z7
Skin Center for Dermatology
[Recruiting]
Peterborough, Ontario, Canada, K9J 5K2
Toronto Research Centre
[Recruiting]
Toronto, Ontario, Canada, M3H 5Y8
K. Papp Clinical Research
[Recruiting]
Waterloo, Ontario, Canada, N2J 1C4
Windsor Clinical Research Inc.
[Recruiting]
Windsor, Ontario, Canada, N8W5L7
Canada, Quebec
Dr Isabelle Delorme inc
[Recruiting]
Drummondville, Quebec, Canada, J2B 5L4
Dre Angelique Gagne-Henley M.D. Inc.
[Recruiting]
Saint-Jerome, Quebec, Canada, J7Z 3B8
Canada, Saskatchewan
Skinsense Medical Research
[Recruiting]
Saskatoon, Saskatchewan, Canada, S7K 0H6
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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