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NCT04762277 · ClinicalTrials.gov registry record · Phase 2
A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT04762277: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT04762277 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04762277, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
This study is open to adults with a chronic inflammatory skin disease called hidradenitis suppurativa. The purpose of this study is to find out whether a medicine called spesolimab helps people with moderate to severe hidradenitis suppurativa. Participants are put into 2 groups by chance. One group takes spesolimab. The other group takes placebo. Every participant has twice the chance of being in the spesolimab group than in the placebo group. Participants get spesolimab or placebo as an infusion into a vein every week for the first 3 weeks. Afterwards, they get spesolimab or placebo as injections under the skin every 2 weeks. Placebo infusions and injections look like spesolimab infusions and injections but do not contain any medicine. Participants are treated in the study for about 3 months. During this time, they visit the study site about 9 times. After completing this part of the study, participants are offered to join another clinical study in which all participants get spesolimab. Participants who cannot join the other study, stay in this study for about 4 more months. During this time, participants do not take spesolimab nor placebo but they visit the study site 2 times to have their health checked. At study visits, doctors thoroughly check the skin of participants to count lumps (nodules) and boils (abscesses). The results between the spesolimab group and the placebo group are compared after 3 months of treatment. The doctors also regularly check the general health of the participants.
Primary Outcome
Percent change from baseline in total abscess and inflammatory nodule count at Week 12= \[(Total Abscess at Week 12 + Total Inflammatory Nodule at Week 12) - (Total Abscess at baseline + Total Inflammatory Nodule at baseline)\] \*100/ (Total Abscess at baseline + Total Inflammatory Nodule at baseline). Percent change from baseline in total abscess and inflammatory nodule count at Week 12 was modelled using mixed effects model for repeated measures (MMRM) accounting for the following sources of
Interventions
- DRUG Spesolimab - solution for infusion
- DRUG Placebo matching spesolimab - solution for infusion
- DRUG Spesolimab- solution for injection
- DRUG Placebo matching to spesolimab- solution for injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-04-06 |
| Est. Completion | 2022-04-21 |
| Phase | Phase 2 |
What the finished NCT04762277 record still lists
NCT04762277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 4 interventions - of which Spesolimab - solution for infusion is the first listed.
NCT04762277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04762277 about?
NCT04762277 is a clinical study titled "A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa". This study is open to adults with a chronic inflammatory skin disease called hidradenitis suppurativa. The purpose of this study is to find out whether a medicine called spesolimab helps people with moderate to severe hidradenitis suppurativa. Participants are put into 2 groups by chance. One group...
What is the current status of trial NCT04762277?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2021-04-06. Estimated completion is 2022-04-21.
What interventions are being tested in trial NCT04762277?
The interventions under investigation include: Spesolimab - solution for infusion (DRUG), Placebo matching spesolimab - solution for infusion (DRUG), Spesolimab- solution for injection (DRUG), Placebo matching to spesolimab- solution for injection (DRUG).
Who is sponsoring clinical trial NCT04762277?
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 NCT04762277's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 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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