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NCT04876391 · ClinicalTrials.gov registry record · Phase 2
A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT04876391: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT04876391 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04876391, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
This study is open to adults with hidradenitis suppurativa who took part in a previous clinical study of a medicine called spesolimab. Participants who completed treatment can join this study. The purpose of this study is to find out how safe spesolimab is and whether it helps people with hidradenitis suppurativa in the long-term. Participants are in this study for about 2 years and 4 months. For 2 years, participants visit the study site every 2 weeks to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' hidradenitis suppurativa and collect information on any health problems of the participants.
Primary Outcome
TEAEs were defined as all adverse events (AEs) occurring from the start of treatment in this extension trial to the end of its residual effect period. AEs that began during the on-treatment period of the parent Proof of Concept and Confirmatory (PoCC) trial (1368-0052) and were still ongoing in this extension trial will also be considered as treatment-emergent.
Interventions
- DRUG Spesolimab 1200 mg
- DRUG Spesolimab 600 mg
- DRUG Placebo matching 600 mg Spesolimab
- DRUG Placebo matching 1200 mg Spesolimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2021-08-24 |
| Est. Completion | 2024-04-26 |
| Phase | Phase 2 |
What the finished NCT04876391 record still lists
NCT04876391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 4 interventions - of which Spesolimab 1200 mg is the first listed.
NCT04876391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04876391 about?
NCT04876391 is a clinical study titled "A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial". This study is open to adults with hidradenitis suppurativa who took part in a previous clinical study of a medicine called spesolimab. Participants who completed treatment can join this study. The purpose of this study is to find out how safe spesolimab is and whether it helps people with hidradeni...
What is the current status of trial NCT04876391?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2021-08-24. Estimated completion is 2024-04-26.
What interventions are being tested in trial NCT04876391?
The interventions under investigation include: Spesolimab 1200 mg (DRUG), Spesolimab 600 mg (DRUG), Placebo matching 600 mg Spesolimab (DRUG), Placebo matching 1200 mg Spesolimab (DRUG).
Who is sponsoring clinical trial NCT04876391?
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 NCT04876391's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 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
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