Trial record 2 of 7 for:
frontier 1 | Plaque Psoriasis
A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis (FRONTIER 2)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05364554 |
|
Recruitment Status :
Completed
First Posted : May 6, 2022
Last Update Posted : November 13, 2023
|
Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Plaque Psoriasis | Drug: JNJ-77242113 | Phase 2 |
The populations of people living with moderate to severe psoriasis is approximately 3.5 billion which are mostly managed with topical and conventional therapies. JNJ-77242113, investigational drug, targets the immune responses in the body and skin which impacts diseases, such as psoriasis and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. This is a long-term extension study of JNJ-77242113 in eligible participants who have completed the Week 16 visit of the originating Study 77242113PSO2001. The total duration of this study will be up to 40 weeks which will include a 36-week treatment period, and a 4-week safety follow-up period after the last study intervention administration. Safety will be assessed by adverse events (AEs), clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 227 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2b Multicenter, Long-Term Extension, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis |
| Actual Study Start Date : | June 10, 2022 |
| Actual Primary Completion Date : | September 29, 2023 |
| Actual Study Completion Date : | September 29, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Group 1: JNJ-77242113 Dose 1 Once Daily (QD)
Participants originally randomized to JNJ-77242113 Dose 1 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 QD from Week 0 through Week 36 in this study.
|
Drug: JNJ-77242113
JNJ-77242113 tablet will be administered orally. |
|
Experimental: Group 2: JNJ-77242113 Dose 2 QD
Participants originally randomized to JNJ-77242113 Dose 2 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 2 QD from Week 0 through Week 36 in this study.
|
Drug: JNJ-77242113
JNJ-77242113 tablet will be administered orally. |
|
Experimental: Group 3: JNJ-77242113 Dose 3 QD
Participants originally randomized to JNJ-77242113 Dose 3 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.
|
Drug: JNJ-77242113
JNJ-77242113 tablet will be administered orally. |
|
Experimental: Group 4: JNJ-77242113 Dose 1 Twice Daily (BID)
Participants originally randomized to JNJ-77242113 Dose 1 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 BID from Week 0 through Week 36 in this study.
|
Drug: JNJ-77242113
JNJ-77242113 tablet will be administered orally. |
|
Experimental: Group 5: JNJ-77242113 Dose 3 BID
Participants originally randomized to JNJ-77242113 Dose 3 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 BID from Week 0 through Week 36 in this study.
|
Drug: JNJ-77242113
JNJ-77242113 tablet will be administered orally. |
|
Experimental: Group 6: JNJ-77242113 Dose 3 QD
Participants originally randomized to placebo in originating Study 77242113PSO2001 will receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.
|
Drug: JNJ-77242113
JNJ-77242113 tablet will be administered orally. |
Primary Outcome Measures :
- Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 36 [ Time Frame: Week 36 ]Percentage of participants achieving PASI 75 score (greater than or equal to [>=] 75 percent [%] improvement in PASI from baseline of the originating study [77242113PSO2001]) at Week 36 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
Secondary Outcome Measures :
- Percentage of Participants Achieving PASI 90 Score at Week 36 [ Time Frame: Week 36 ]Percentage of participants achieving PASI 90 score (>=90% improvement in PASI from baseline of the originating study [77242113PSO2001]) at Week 36 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
- Percentage of Participants Achieving PASI 100 Score at Week 36 [ Time Frame: Week 36 ]Percentage of participants achieving PASI 100 score (>=100% improvement in PASI from baseline of the originating study [77242113PSO2001]) at Week 36 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
- Change From Baseline in PASI Total Score at Week 36 [ Time Frame: Baseline and Week 36 ]Change from baseline of the originating study (77242113PSO2001) in PASI total score at Week 36 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
- Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 36 [ Time Frame: Week 36 ]Percentage of participants who achieve an IGA score of cleared (0) or minimal (1) at Week 36 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
- Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 36 [ Time Frame: Baseline and Week 36 ]Change from baseline of originating Study (77242113PSO2001) in PSSD symptoms scores at Week 36 will be reported. The PSSD includes patient-reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
- Change from Baseline in PSSD Signs Score at Week 36 [ Time Frame: Baseline and Week 36 ]Change from baseline of originating study (77242113PSO2001) in PSSD signs score at Week 36 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
- Percentage of Participants Achieving PSSD Symptoms Score=0 at Week 36 Among Participants With a Baseline (in the Originating Study) Symptoms Score >=1 [ Time Frame: Week 36 ]Percentage of participants achieving PSSD symptoms score=0 at Week 36 among participants with a baseline (in the originating study 77242113PSO2001) symptoms score >=1 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
- Percentage of Participants Achieving PSSD Signs Score=0 at Week 36 Among Participants With a Baseline (in the Originating Study) Signs Score >=1 [ Time Frame: Week 36 ]Percentage of participants achieving PSSD signs score=0 at week 36 among participants with a baseline (in the originating study) signs score >=1 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
- Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Week 40 ]An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
- Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Week 40 ]SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must have completed the Week 16 visit in Protocol 77242113PSO2001
- In the opinion of the investigator, may benefit from inclusion in this long term extension (LTE) study
- Must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study
- Must agree to discontinue all topical therapies that could affect psoriasis or the psoriasis area severity index (PASI) or investigator's global assessment (IGA) evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention
- Agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of study intervention
Exclusion Criteria:
- Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason
- Has received any biologic therapy or experimental therapy since completion of the originating study, 77242113PSO2001
- Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention
- Has received the bacille Calmette-Guerin (BCG) vaccine within 12 months of the first administration of study intervention
- Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or has other clinically active liver disease, or tests positive for HBsAg or anti-HCV
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05364554
Locations
Show 60 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT05364554 |
| Other Study ID Numbers: |
CR109155 2021-004320-16 ( EudraCT Number ) 77242113PSO2002 ( Other Identifier: Janssen Research & Development, LLC ) |
| First Posted: | May 6, 2022 Key Record Dates |
| Last Update Posted: | November 13, 2023 |
| Last Verified: | November 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu |
| URL: | https://www.janssen.com/clinical-trials/transparency |
| 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 |