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New drug shows promise for painful skin condition

NCT ID NCT05216224

Disease control Sponsor: Aclaris Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called ATI-450 in 95 people with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition causing painful lumps. The goal was to see if the drug reduces the number of abscesses and inflamed nodules compared to a placebo over 12 weeks. The trial has been completed, and results will help determine if ATI-450 can control this disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

95 people

The number who actually took part.

Started

Dec 2021

Finished

Jan 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Able to comprehend and be willing to sign the Institutional Review Board (IRB)-approved participant informed consent form prior to administration of any study-related procedures. * Participant must have stable HS. * Total abscesses and/or nodule (AN) count of ≥5 at Baseline visit. * HS lesions present in at least 2 distinct anatomical areas at Screening and Baseline. Exclusion Criteria: * Participant has a history of active skin disease other than HS that could interfere with the assessment of HS. * Participant has an uncontrolled non-immunoinflammatory disease that may place the participant at increased risk during the study or impact the interpretation of results, e.g., previous malignancy, previous venous thromboembolism. * Participant has experience with \>2 biologics, \>1 Janus kinase (JAK) inhibitor, or a combination of 1 biologic experience and 1 JAK inhibitor. * Are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of the Screening visit.

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Conditions

The condition(s) this trial relates to.

hidradenitis hidradenitis suppurativa

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hidradenitis suppurativa

Contacts and locations

Locations

  • Aclaris Investigational Site

    Birmingham, Alabama, 35244, United States

  • Aclaris Investigational Site

    Fort Smith, Arkansas, 72916, United States

  • Aclaris Investigational Site

    Encino, California, 91436, United States

  • Aclaris Investigational Site

    San Francisco, California, 94115, United States

  • Aclaris Investigational Site

    Thousand Oaks, California, 91436, United States

  • Aclaris Investigational Site

    Boca Raton, Florida, 33486, United States

  • Aclaris Investigational Site

    Hollywood, Florida, 33021, United States

  • Aclaris Investigational Site

    Tampa, Florida, 33613, United States

  • Aclaris Investigational Site

    Marietta, Georgia, 30060, United States

  • Aclaris Investigational Site

    Sandy Springs, Georgia, 30328, United States

  • Aclaris Investigational Site

    Metairie, Louisiana, 70006, United States

  • Aclaris Investigational Site

    Fort Gratiot, Michigan, 48059, United States

  • Aclaris Investigational Site

    Charlotte, North Carolina, 28277, United States

  • Aclaris Investigational Site

    Athens, Ohio, 45701, United States

  • Aclaris Investigational Site

    Mason, Ohio, 45040, United States

  • Aclaris Investigational Site

    Hershey, Pennsylvania, 17033, United States

  • Aclaris Investigational Site

    Anderson, South Carolina, 29621, United States

  • Aclaris Investigational Site

    Nashville, Tennessee, 37215, United States

  • Aclaris Investigational Site

    Houston, Texas, 77054, United States

  • Aclaris Investigational Site

    Sugar Land, Texas, 77478, United States

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Other studies related to the condition(s) this trial covers.