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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 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 52 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04762277
The ClinicalTrials.gov registry entry for NCT04762277 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Spesolimab - solution for infusion is the first listed.
NCT04762277 reports 0 study locations.
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.
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