Study Stopped
Due to company decision.
A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is
Phase II Long-term Extension Study to Assess the Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis
2 other identifiers
interventional
165
3 countries
30
Brief Summary
To assess long-term safety, tolerability, and efficacy of BI 730357 in patients with moderate to severe chronic plaque psoriasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2019
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2019
CompletedFirst Posted
Study publicly available on registry
February 8, 2019
CompletedStudy Start
First participant enrolled
March 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2021
CompletedResults Posted
Study results publicly available
November 18, 2022
CompletedNovember 18, 2022
October 1, 2022
2.3 years
February 7, 2019
June 20, 2022
October 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of participants with treatment emergent adverse events (TEAEs). For dose groups 25 mg - 200 mg BI, TEAEs are reported separately for period 1 and period 2. Period 1: All patients who started in period 1 are reported by starting dose (25, 50, 100 and 200 mg). Period 2: Only patients who participated in period 2 are reported by dose sequence group. For dose group 400 mg BI, TEAEs are reported overall (period 1 + period 2). Number of participants with TEAEs is reported.
For part 1 patients in period 1: Up to 117 days. For part 1 patients in period 2: From week 13 onwards, up to 692 days. For part 2 patients (period 1 + 2): Up to 802 days.
Secondary Outcomes (6)
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24
At baseline and at week 24.
Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24
At week 24.
Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24
At week 24.
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response
Up to 802 days.
Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response
Up to 802 days.
- +1 more secondary outcomes
Study Arms (5)
25 mg BI 730357
EXPERIMENTAL25 mg BI 730357 + placebo under fasted conditions.
50 mg BI 730357
EXPERIMENTAL50 mg BI 730357 + placebo under fasted conditions.
100 mg BI 730357
EXPERIMENTAL100 mg BI 730357 + placebo under fasted conditions.
200 mg BI 730357
EXPERIMENTAL200 mg BI 730357 + placebo under fasted conditions
400 mg BI 730357
EXPERIMENTAL400 mg BI 730357 + placebo under fasted conditions.
Interventions
Film-coated tablet
Film-coated tablet
Eligibility Criteria
You may qualify if:
- Woman Of Child Bearing Potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (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.
- Patients with moderate-to-severe plaque Psoriasis (PsO) who have completed treatment in the preceding trial without early discontinuation, agree to continue treatment in 1407-0005, and
- for patients entering from Part 1 of trial 1407-0030
- \--- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 24 end-of-treatment visit
- for patients entering from Part 2 of trial 1407-0030 --- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 12 end-of-treatment visit or perceived patient improvement, at the discretion of the Investigator
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
You may not qualify if:
- 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.
- Previous enrolment in this trial.
- Currently enrolled in another investigational device or drug trial or is receiving other investigational treatment(s) (with the exception of 1407-0030).
- Intake of any restricted medication or any drug considered likely to interfere with the safe conduct of the trial.
- Any plan to receive a live vaccination during the conduct of the trial.
- Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled.
- Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes the patient an unreliable trial participant or unlikely to complete the trial.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Any documented active or suspected malignancy, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix.
- Relevant chronic or acute infections including human immunodeficiency virus (HIV), viral hepatitis and tuberculosis.
- Evidence of a disease (including known or suspected IBD, cardiovascular disease), or medical finding that in the opinion of the Investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data.
- Any suicidal ideation, including grade 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 12 months (i.e., active suicidal thought with intent but without specific plan), or active suicidal thought with plan and intent in the past.
- Unwillingness to adhere to the rules of UV-light protection
- Ongoing AEs consistent with intolerance of trial medication (including gastric intolerance) from 1407-0030, that in the opinion of the investigator would compromise the safety of the patient.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Southern California Dermatology Inc.
Santa Ana, California, 92701, United States
Hamilton Research
Alpharetta, Georgia, 30022, United States
Advanced Medical Research PC
Sandy Springs, Georgia, 30328, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
The Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10003, United States
Clinical Partners, LLC
Johnston, Rhode Island, 02919, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Menter Dermatology Research Institute
Dallas, Texas, 75246, United States
Center for Clinical Studies
Houston, Texas, 77004, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502, United States
Dr Chih-ho Hong Medical Inc
Surrey, British Columbia, V3R 6A7, Canada
Enverus Medical Research
Surrey, British Columbia, V3V 0C6, Canada
Dr. Irina Turchin PC Inc.
Fredericton, New Brunswick, E3B 1G9, Canada
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7, Canada
DermEdge Research Inc.
Mississauga, Ontario, L5H 1G9, Canada
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7, Canada
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
K. Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4, Canada
XLR8 Medical Research Inc.
Windsor, Ontario, N8W 1E6, Canada
Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, 60596, Germany
TFS Trial Form Support GmbH
Hamburg, 20537, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Related Publications (2)
Gooderham MJ, Mrowietz U, Kadus W, Drda K, Gu H, Vangerow H, Flack M, Korell J, Sofen H, Papp KA. Phase II Randomized Trial of BI 730357, an Oral RORgammat Inhibitor, for Moderate-to-Severe Plaque Psoriasis. J Invest Dermatol. 2025 Aug;145(8):1969-1978.e14. doi: 10.1016/j.jid.2024.12.025. Epub 2025 Jan 21.
PMID: 39848568DERIVEDOoi QX, Kristoffersson A, Korell J, Flack M, L Plan E, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023 Jun;12(6):758-769. doi: 10.1002/psp4.12948. Epub 2023 May 1.
PMID: 36919398DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The trial was ended prematurely by the sponsor. As a consequence, primary and secondary endpoints were limited to descriptive outcome measures. The recruitment was completed as planned.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Centre
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2019
First Posted
February 8, 2019
Study Start
March 18, 2019
Primary Completion
June 22, 2021
Study Completion
July 27, 2021
Last Updated
November 18, 2022
Results First Posted
November 18, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.