This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is
Public ClinicalTrials.gov record NCT03635099. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase II Evaluation of Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective is based on Week 12 co-primary endpoints of PASI (Psoriasis Area and Severity Index) 75 and sPGA (Static Physician's Global Assessment) 0/1, and overall safety Secondary objectives of Part 1 are to evaluate the efficacy and safety of BI 730357 through 24 weeks of treatment
Study identification
- NCT ID
- NCT03635099
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 274 participants
Conditions and interventions
Conditions
Interventions
- Placebo (fasted) Drug
- BI 25 mg (fasted) Drug
- BI 50 mg (fasted) Drug
- BI 100 mg (fasted) Drug
- BI 200 mg (fasted) Drug
- Placebo (fed) Drug
- BI 400 mg once daily (fed) Drug
- BI 200 mg twice daily, 400 mg total (fed) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 17, 2018 (Actual)
- Primary completion
- May 6, 2021 (Actual)
- Completion
- May 26, 2021 (Actual)
- Last update posted
- Aug 3, 2022
2018 – 2021
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama | 35205 | — |
| Dermatology Research Associates | Los Angeles | California | 90045 | — |
| Southern California Dermatology Inc. | Santa Ana | California | 92701 | — |
| Hamilton Research | Alpharetta | Georgia | 30022 | — |
| Advanced Medical Research PC | Sandy Springs | Georgia | 30328 | — |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | — |
| The Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10003 | — |
| Synexus | Cincinnati | Ohio | 45236 | — |
| Clinical Partners, LLC | Johnston | Rhode Island | 02919 | — |
| Clinical Research Center of the Carolinas | Charleston | South Carolina | 29407 | — |
| Health Concepts | Rapid City | South Dakota | 57702 | — |
| Menter Dermatology Research Institute | Dallas | Texas | 75246 | — |
| Center for Clinical Studies | Houston | Texas | 77004 | — |
| Center for Clinical Studies | Webster | Texas | 77598 | — |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03635099, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 3, 2022 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03635099 live on ClinicalTrials.gov.