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NCT05819398 · ClinicalTrials.gov registry record · Phase 2
Lunsayil 1: 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
- 209
- Enrollment target
NCT05819398: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT05819398 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 209 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05819398, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 209 participants
- Enrollment target
Study Summary
This study is open to adults with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to find out whether a medicine called spesolimab helps people with HS. People who have previously taken specific medicines such as immunosuppressive biologics other than Tumor necrosis factor (TNF) inhibitors cannot take part. This study has 2 parts. In Part 1, participants are divided into 4 groups of almost equal size. 3 groups get different doses of spesolimab, 1 group gets placebo. All participants get injections into a vein or under the skin. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has an equal chance of being in each group. In the beginning, participants get the study medicine every week and later every 2 weeks. After 4 months, participants in the placebo group switch to spesolimab treatment. In Part 2, participants are divided into 2 groups. One group gets a suitable dose of spesolimab that was found in Part 1 of the study. The other group gets placebo. After 4 months, participants in the placebo group switch to spesolimab treatment. Participants join only one of the two parts. They are in the study for about 1 year. During this time, they visit the study site in the beginning every week and later every 2 weeks. Some of the visits can be done at the participant's home instead of the study site. The doctors regularly check participants' HS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.
Primary Outcome
Percent change from baseline in draining fistula/tunnel (dT) count at Week 8 is reported. Tunnel/fistula/sinus were counted as dT only if draining. Percent change was calculated as follows: (dT count at week 8 - dT count at baseline)/ dT at baseline. Least square means and standard errors were estimated by Mixed effect model for repeated measurements (MMRM). The MMRM included fixed categorical effects of treatment at each visit, Tumor Necrosis Factor inhibitor (TNFi) status at baseline, and cat
Interventions
- DRUG Spesolimab i.v.
- DRUG Spesolimab s.c.
- DRUG Placebo matching Spesolimab i.v.
- DRUG Placebo matching Spesolimab s.c.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2023-04-17 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 2 |
What the finished NCT05819398 record still lists
NCT05819398 is an interventional study that assigns participants to a tested intervention. The registered 209 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 (57% higher).
The record links to 0 conditions, and to 4 interventions - of which Spesolimab i.v. is the first listed.
NCT05819398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05819398 about?
NCT05819398 is a clinical study titled "Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa". This study is open to adults with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to find out whether a medicine called spesolimab helps people with HS. People who have previously taken specific medicines such as immunosuppressive biologics other than Tumor necrosis fa...
What is the current status of trial NCT05819398?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 209 participants. The study started on 2023-04-17. Estimated completion is 2025-03-31.
What interventions are being tested in trial NCT05819398?
The interventions under investigation include: Spesolimab i.v. (DRUG), Spesolimab s.c. (DRUG), Placebo matching Spesolimab i.v. (DRUG), Placebo matching Spesolimab s.c. (DRUG).
Who is sponsoring clinical trial NCT05819398?
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 NCT05819398's enrollment target sits among peer trials
209 294th of 2000 higher than 1,707 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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