A study to test how well patients with plaque psoriasis tolerate BI 730357 over a longer period and how effective it is
- Conditions
- Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-003487-31-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
1. WOCBP must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly from date of screening until 4 weeks after last treatment in this trial. A list of contraception methods meeting these criteria is provided in the patient information.
2. Patients with moderate-to-severe plaque PsO who have completed the randomized treatment period without early treatment discontinuation in the preceding trial, achieved a PASI50 at Week 24 of the preceding trial, and are willing and able to continue treatment in this study.
3. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1. Nonplaque forms of PsO (including guttate, erythrodermic, or pustular), current druginduced PsO (including a new onset or exacerbation of PsO from, e.g., beta blockers, calcium channel blockers, lithium), active ongoing inflammatory diseases (including but not limited to inflammatory bowel disease (IBD)) other than PsO that might confound trial evaluations.
2. Previous enrolment in this trial.
3. Currently enrolled in another investigational device or drug trial or is receiving other investigational treatment(s) (with the exception of 1407-0030).
4. Intake of any restricted medication or any drug considered likely to interfere with the safe conduct of the trial.
5. Any plan to receive a live vaccination during the conduct of the trial.
6. Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled.
7. Further criteria apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Not applicable.;Primary end point(s): 1 - The exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE);Timepoint(s) of evaluation of this end point: 1 - Up to Week 288;Main Objective: Assess long-term safety, tolerability, and efficacy of BI 730357 in patients with moderate to severe chronic plaque psoriasis.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1- Achievement of Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/ PASI100 <br>2- Achievement of Static Physician’s Global Assessment (sPGA) clear or almost clear <br>3- Achievement of sPGA clear <br>4- Time to loss of PASI50/PASI75/PASI90/PASI100 for patients who achieve the response <br>5- Time to loss of sPGA clear or almost clear for patients who achieve the response<br>6- Time to loss of sPGA clear for patients who achieve the response;Timepoint(s) of evaluation of this end point: 1- Up to Week 24<br>2- Up to Week 24<br>3- Up to Week 24<br>4- Up to Week 288<br>5- Up to Week 288<br>6- Up to Week 288