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NCT04242446 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
A Phase 3 study of Hidradenitis Suppurativa, sponsored by UCB Biopharma SRL.
- Completed
- Registry status
- Phase 3
- Development phase
- 505
- Enrollment target
- 20
- Study locations
NCT04242446: Completed Phase 3 study of Hidradenitis Suppurativa, sponsored by UCB Biopharma SRL.
NCT04242446 is a Phase 3 study of Hidradenitis Suppurativa that has completed, run by UCB Biopharma SRL. The registered enrollment target is 505 participants, below the 588-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04242446, a Phase 3 study of Hidradenitis Suppurativa, has completed, sponsored by UCB Biopharma SRL.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 505 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)
Primary Outcome
HiSCR50 was defined as at least a 50 percent (%) reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data are imputed using multiple imputation with Markov Chain Monte Carlo (MCMC) method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Bimekizumab
Study Locations (20)
Florida
- Hs0003 50205 - North Miami Beach
- Hs0003 50153 - Ormond Beach
- Hs0003 50141 - Tampa
California
- Hs0003 50161 - Los Angeles
- Hs0003 50220 - San Diego
Georgia
- Hs0003 50210 - Atlanta
- Hs0003 50280 - Watkinsville
Massachusetts
- Hs0003 50198 - Beverly
- Hs0003 50146 - Boston
Ohio
- Hs0003 50177 - Cincinnati
- Hs0003 50138 - Columbus
Alabama
- Hs0003 50140 - Birmingham
Arizona
- Hs0003 50175 - Phoenix
Kentucky
- Hs0003 50425 - Murray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 505 participants |
| Start Date | 2020-02-19 |
| Est. Completion | 2023-02-19 |
| Phase | Phase 3 |
What the finished NCT04242446 record still lists
NCT04242446 is an interventional study that assigns participants to a tested intervention. The registered 505 participants enrollment target is mid-sized for trials with a published cap, below the 588-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (14% lower).
The record links to 1 condition, with Hidradenitis Suppurativa appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04242446 names 20 study sites across 14 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04242446 about?
NCT04242446 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa". The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)
What is the current status of trial NCT04242446?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 505 participants. The study started on 2020-02-19. Estimated completion is 2023-02-19.
What conditions does trial NCT04242446 study?
This clinical trial studies the following conditions: Hidradenitis Suppurativa.
What interventions are being tested in trial NCT04242446?
The interventions under investigation include: Placebo (OTHER), Bimekizumab (DRUG).
Who is sponsoring clinical trial NCT04242446?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04242446 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04242446's enrollment target sits among peer trials
505 14th of 52 higher than 39 of 52 other Hidradenitis Suppurativa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hidradenitis Suppurativa 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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