A multicenter, open-label study to assess the long-term safety, torelability, and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
- Conditions
- Psoriasis (Psoriasis, Psoriatic arthritis, Erythrodermic psoriasis, Generalized pustular psoriasis)
- Registration Number
- JPRN-jRCT2080224002
- Lead Sponsor
- CB Japan Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 160
[Cohort A]
- Female subjects who plan to become pregnant during the study
- Subject has a positive or indeterminate IGRA in a feeder study, unless appropriately evaluated and treated
[Cohort B]
- Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
- Subject has guttate PSO or drug-induced PSO
- Subject has an active infection or history of infections
- Subject has known TB infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
- Subject has a diagnosis of inflammatory conditions other than PSO, PsA, GPP, or EP, including but not limited to rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, Crohn's disease, or ulcerative colitis
- Subject has GPP or EP
- Subject has experienced primary failure (no response within 12 weeks) to 1 or more IL-17 biologic response modifier (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier other than an IL-17
- Subject has a differential diagnosis of the erythroderma (eg, erythroderma caused by lymphoma or drug eruption) other than EP
- Subject with a primary failure to any prior biologic therapy (primary failure defined as no response within the first 12 weeks of treatment with the biologic)
[Cohort A]
- Female subjects who plan to become pregnant during the study
- Subject has a positive or indeterminate IGRA in a feeder study, unless appropriately evaluated and treated
[Cohort B]
- Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
- Subject has guttate PSO or drug-induced PSO.
- Subject has an active infection or history of infections
- Subject has known TB infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.
- Subject has a diagnosis of inflammatory conditions other than PSO, PsA, GPP, or EP, including but not limited to rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, Crohn's disease, or ulcerative colitis.
- Subject has GPP or EP
- Subject has experienced primary failure (no response within 12 weeks) to 1 or more IL-17 biologic response modifier (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier other than an IL-17.
- Subject has a differential diagnosis of the erythroderma (eg, erythroderma caused by lymphoma or drug eruption) other than EP
- Subject with a primary failure to any prior biologic therapy (primary failure defined as no response within the first 12 weeks of treatment with the biologic).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>The incidence of TEAEs adjusted by duration of subject exposure to treatment
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>[Cohort A]<br>- Incidence of SAEs adjusted by duration of subject exposure to treatment<br>- Incidence of TEAEs leading to withdrawal adjusted by duration of subject exposure to treatment<br>- PASI90 at Week 144<br>- IGA response at Week 144<br><br>[Cohort B]<br>- PASI90 at Week 144<br>- IGA response at Week 144