A Long-Term Extension Study of JNJ-77242113 in Participants with Moderate-to-Severe Plaque Psoriasis
- Conditions
- Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2021-004320-16-DE
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
1. Must have completed the Week 16 visit in Protocol 77242113PSO2001.
2. In the opinion of the investigator, may benefit from inclusion in this LTE study.
3. Must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study.
4. Must agree to discontinue all topical therapies that could affect psoriasis or the PASI or IGA evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention.
5. A woman of childbearing potential must have a negative urine pregnancy test at Week 0 prior to dispensing study intervention.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 216
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24
1. Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason.
2. Has received any biologic therapy or experimental therapy since completion of the originating study, 77242113PSO2001.
3. Has received any phototherapy or systemic treatment, with the exception of systemic corticosteroids taken <2 weeks in duration, that could impact the assessment of psoriasis (PASI/IGA) since completion of the originating study, 77242113PSO2001, and within 4 weeks of the first administration of study intervention.
4. Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention. For exclusions related to the bacille Calmette-Guerin (BCG) vaccine, see Exclusion 5.
5. Has received the BCG vaccine within 12 months of the first administration of study intervention.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis;Secondary Objective: - To evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis<br>- To evaluate the effect of JNJ-77242113 treatment on patient-reported psoriasis severity in participants with moderate-to-severe plaque psoriasis<br>- To assess the safety and tolerability of JNJ-77242113 in participants with moderate-to-severe plaque psoriasis<br>;Primary end point(s): Proportion of participants achieving PASI 75 (=75% improvement in PASI from baseline of the originating study 77242113PSO2001);Timepoint(s) of evaluation of this end point: Week 36
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Proportion of participants achieving PASI 90 (=90% improvement in PASI from baseline of the originating study)<br>- Proportion of participants achieving PASI 100 (100% improvement in PASI from baseline of the originating study)<br>- Change from baseline of the originating study in PASI total score<br>- Proportion of participants achieving an IGA score of cleared (0) or minimal (1)<br>- Change from baseline of the originating study in Psoriasis Symptoms and Signs Diary (PSSD) symptoms score<br>- Change from baseline of originating study in PSSD signs score<br>- Proportion of participants achieving PSSD symptoms score=0 at among participants with a baseline (in the originating study) symptoms score =1<br>- Proportion of participants achieving PSSD signs score=0 among participants with a baseline (in the originating study) signs score =1<br>- Frequency and type of AEs and SAEs;Timepoint(s) of evaluation of this end point: Week 36