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NCT06411899 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

A Phase 3 study of Hidradenitis Suppurativa, sponsored by MoonLake Immunotherapeutics.

Active
Registry status
Phase 3
Development phase
422
Enrollment target
20
Study locations

NCT06411899: Active Phase 3 study of Hidradenitis Suppurativa, sponsored by MoonLake Immunotherapeutics.

NCT06411899 is a Phase 3 study of Hidradenitis Suppurativa that is active but no longer recruiting, run by MoonLake Immunotherapeutics. The registered enrollment target is 422 participants, below the 590-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06411899, a Phase 3 study of Hidradenitis Suppurativa, is active but no longer recruiting, sponsored by MoonLake Immunotherapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
422 participants
Enrollment target
20
Study locations

Study Summary

This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.

Primary Outcome

Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) where HiSCR75 is defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count.

Conditions Studied

Hidradenitis Suppurativa

Interventions

  • DRUG Placebo
  • DRUG Sonelokimab

Study Locations (20)

Florida

  • Clinical Site - Coral Gables
  • Clinical Site - Coral Springs
  • Clinical Site - Hollywood
  • Clinical Site - Margate
  • Clinical Site - Miami
  • Clinical Site - Tampa

California

  • Clinical Site - Los Angeles
  • Clinical Site - Northridge
  • Clinical Site - Sacramento
  • Clinical Site - San Diego

Georgia

  • Clinical Site - Macon
  • Clinical Site - Sandy Springs

Indiana

  • Clinical Site - Columbus
  • Clinical Site - New Albany

Massachusetts

  • Clinical Site - Boston
  • Clinical Site - Boston

Illinois

  • Clinical Site - West Dundee

Kentucky

  • Clinical Site - Louisville

Louisiana

  • Clinical Site - Metairie

Trial Details

FieldValue
Enrollment Target 422 participants
Start Date 2024-05-15
Est. Completion 2026-06-17
Phase Phase 3
MoonLake Immunotherapeutics

7 total trials

What the registry record for NCT06411899 still lists

NCT06411899 is an interventional study that assigns participants to a tested intervention. The registered 422 participants enrollment target is mid-sized for trials with a published cap, below the 590-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (28% 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.

NCT06411899 names 20 study sites across 9 states, led by Florida, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT06411899 about?

NCT06411899 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa". This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to W...

What is the current status of trial NCT06411899?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 422 participants. The study started on 2024-05-15. Estimated completion is 2026-06-17.

What conditions does trial NCT06411899 study?

This clinical trial studies the following conditions: Hidradenitis Suppurativa.

What interventions are being tested in trial NCT06411899?

The interventions under investigation include: Placebo (DRUG), Sonelokimab (DRUG).

Who is sponsoring clinical trial NCT06411899?

This trial is sponsored by MoonLake Immunotherapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06411899 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Hidradenitis Suppurativa

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06411899's enrollment target sits among peer trials

422 15th of 52 higher than 38 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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Related registry views

Source: ClinicalTrials.gov NCT06411899, the US trial registry maintained by the National Library of Medicine. NCT06411899 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.