A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis (FRONTIER 2)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: JNJ-77242113

Study type: Interventional

Funder types: Industry

Identifiers

NCT05364554

2021-004320-16 (EudraCT Number)

77242113PSO2002 (Other Identifier)

CR109155

Details and patient eligibility

About

The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis.

Full description

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.

Enrollment: 227 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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227 participants in 6 patient groups

Group 1: JNJ-77242113 Dose 1 Once Daily (QD)

Experimental group

Description:

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.

Treatment:

Drug: JNJ-77242113

Group 2: JNJ-77242113 Dose 2 QD

Experimental group

Description:

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.

Treatment:

Drug: JNJ-77242113

Group 3: JNJ-77242113 Dose 3 QD

Experimental group

Description:

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.

Treatment:

Drug: JNJ-77242113

Group 4: JNJ-77242113 Dose 1 Twice Daily (BID)

Experimental group

Description:

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.

Treatment:

Drug: JNJ-77242113

Group 5: JNJ-77242113 Dose 3 BID

Experimental group

Description:

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.

Treatment:

Drug: JNJ-77242113

Group 6: JNJ-77242113 Dose 3 QD

Experimental group

Description:

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.

Treatment:

Drug: JNJ-77242113