Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03635099 · ClinicalTrials.gov registry record · Phase 2
This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 274
- Enrollment target
NCT03635099: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT03635099 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 274 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (106% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03635099, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 274 participants
- Enrollment target
Study Summary
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
Primary Outcome
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 75 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease. PASI 75 is based on the percent reduction
Interventions
- DRUG Placebo (fasted)
- DRUG BI 25 mg (fasted)
- DRUG BI 50 mg (fasted)
- DRUG BI 100 mg (fasted)
- DRUG BI 200 mg (fasted)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2018-09-17 |
| Est. Completion | 2021-05-26 |
| Phase | Phase 2 |
What the finished NCT03635099 record still lists
NCT03635099 is an interventional study that assigns participants to a tested intervention. The registered 274 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (106% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo (fasted) is the first listed.
NCT03635099 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03635099 about?
NCT03635099 is a clinical study titled "This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is". 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
What is the current status of trial NCT03635099?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 274 participants. The study started on 2018-09-17. Estimated completion is 2021-05-26.
What interventions are being tested in trial NCT03635099?
The interventions under investigation include: Placebo (fasted) (DRUG), BI 25 mg (fasted) (DRUG), BI 50 mg (fasted) (DRUG), BI 100 mg (fasted) (DRUG), BI 200 mg (fasted) (DRUG).
Who is sponsoring clinical trial NCT03635099?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03635099's enrollment target sits among peer trials
274 203rd of 2000 higher than 1,797 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03808922 · 274 participants · Phase 3
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
- NCT04573504 · 274 participants · Phase 4
Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair
- NCT05289557 · 274 participants · Phase 3
The Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
- NCT05952583 · 274 participants
Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI