A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is
NCT ID: NCT03835481
Last Updated: 2022-11-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
165 participants
INTERVENTIONAL
2019-03-18
2021-07-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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25 mg BI 730357
25 mg BI 730357 + placebo under fasted conditions.
BI 730357
Film-coated tablet
Placebo to match BI 730357
Film-coated tablet
50 mg BI 730357
50 mg BI 730357 + placebo under fasted conditions.
BI 730357
Film-coated tablet
Placebo to match BI 730357
Film-coated tablet
100 mg BI 730357
100 mg BI 730357 + placebo under fasted conditions.
BI 730357
Film-coated tablet
Placebo to match BI 730357
Film-coated tablet
200 mg BI 730357
200 mg BI 730357 + placebo under fasted conditions
BI 730357
Film-coated tablet
Placebo to match BI 730357
Film-coated tablet
400 mg BI 730357
400 mg BI 730357 + placebo under fasted conditions.
BI 730357
Film-coated tablet
Interventions
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BI 730357
Film-coated tablet
Placebo to match BI 730357
Film-coated tablet
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
Dermatology Research Associates
Los Angeles, California, United States
Southern California Dermatology Inc.
Santa Ana, California, United States
Hamilton Research
Alpharetta, Georgia, United States
Advanced Medical Research PC
Sandy Springs, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
The Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States
Health Concepts
Rapid City, South Dakota, United States
Menter Dermatology Research Institute
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Dr Chih-ho Hong Medical Inc
Surrey, British Columbia, Canada
Enverus Medical Research
Surrey, British Columbia, Canada
Dr. Irina Turchin PC Inc.
Fredericton, New Brunswick, Canada
The Guenther Dermatology Research Centre
London, Ontario, Canada
DermEdge Research Inc.
Mississauga, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
The Centre for Clinical Trials
Oakville, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
K. Papp Clinical Research Inc.
Waterloo, Ontario, Canada
XLR8 Medical Research Inc.
Windsor, Ontario, Canada
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
TFS Trial Form Support GmbH
Hamburg, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, , Germany
Universitätsklinikum Münster
Münster, , Germany
Countries
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References
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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.
Ooi 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2018-003487-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1407-0005
Identifier Type: -
Identifier Source: org_study_id
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