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NCT05322473 · ClinicalTrials.gov registry record · Phase 2

Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa

A Phase 2 study, sponsored by MoonLake Immunotherapeutics.

Completed
Registry status
Phase 2
Development phase
234
Enrollment target

NCT05322473: Completed Phase 2 study, sponsored by MoonLake Immunotherapeutics.

NCT05322473 is a Phase 2 study that has completed, run by MoonLake Immunotherapeutics. The registered enrollment target is 234 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05322473, a Phase 2 study, has completed, sponsored by MoonLake Immunotherapeutics.

COMPLETED
Registry status
Phase 2
Development phase
234 participants
Enrollment target

Study Summary

This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.

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.

Interventions

  • OTHER Placebo
  • DRUG Adalimumab
  • DRUG Sonelokimab (M1095)

Trial Details

FieldValue
Enrollment Target 234 participants
Start Date 2022-04-25
Est. Completion 2023-08-30
Phase Phase 2
MoonLake Immunotherapeutics

7 total trials

What the finished NCT05322473 record still lists

NCT05322473 is an interventional study that assigns participants to a tested intervention. The registered 234 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 (76% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT05322473 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05322473 about?

NCT05322473 is a clinical study titled "Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa". This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.

What is the current status of trial NCT05322473?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 234 participants. The study started on 2022-04-25. Estimated completion is 2023-08-30.

What interventions are being tested in trial NCT05322473?

The interventions under investigation include: Placebo (OTHER), Adalimumab (DRUG), Sonelokimab (M1095) (DRUG).

Who is sponsoring clinical trial NCT05322473?

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

How this trial's enrollment target compares

Where NCT05322473's enrollment target sits among peer trials

234 255th of 2000 higher than 1,745 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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Source: ClinicalTrials.gov NCT05322473, the US trial registry maintained by the National Library of Medicine. NCT05322473 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.