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NCT05216224 · ClinicalTrials.gov registry record · Phase 2

ATI-450 vs Placebo in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)

A Phase 2 study, sponsored by Aclaris Therapeutics.

Completed
Registry status
Phase 2
Development phase
95
Enrollment target

NCT05216224: Completed Phase 2 study, sponsored by Aclaris Therapeutics.

NCT05216224 is a Phase 2 study that has completed, run by Aclaris Therapeutics. The registered enrollment target is 95 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05216224, a Phase 2 study, has completed, sponsored by Aclaris Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
95 participants
Enrollment target

Study Summary

This is a Phase 2a study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 vs placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).

Primary Outcome

AN count was the sum of number of abscess and inflammatory nodules across anatomical regions. The least square (LS) mean change from baseline in the count at Week 12 was estimated from the Mixed Model Repeated Measures (MMRM) model.

Interventions

  • DRUG Placebo oral tablet
  • DRUG ATI-450

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2021-12-29
Est. Completion 2023-01-24
Phase Phase 2
Aclaris Therapeutics

33 total trials

What the finished NCT05216224 record still lists

NCT05216224 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.

NCT05216224 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05216224 about?

NCT05216224 is a clinical study titled "ATI-450 vs Placebo in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)". This is a Phase 2a study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 vs placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).

What is the current status of trial NCT05216224?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2021-12-29. Estimated completion is 2023-01-24.

What interventions are being tested in trial NCT05216224?

The interventions under investigation include: Placebo oral tablet (DRUG), ATI-450 (DRUG).

Who is sponsoring clinical trial NCT05216224?

This trial is sponsored by Aclaris Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05216224's enrollment target sits among peer trials

95 759th of 2000 higher than 1,237 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 NCT05216224, the US trial registry maintained by the National Library of Medicine. NCT05216224 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.