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

  • STATUS
    Recruiting
  • End date
    Dec 14, 2022
  • participants needed
    70
  • sponsor
    Aclaris Therapeutics, Inc.
Updated on 14 March 2022

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).

Description

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

Details
Condition Hidradenitis Suppurativa
Treatment Placebo Oral Tablet, ATI-450
Clinical Study IdentifierNCT05216224
SponsorAclaris Therapeutics, Inc.
Last Modified on14 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to comprehend and be willing to sign the Institutional Review. Board (IRB)-approved patient prior to administration of any study-related procedures
Patient 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

Patient has a history of active skin disease other than HS that could interfere with the assessment of HS
Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results, e.g., previous malignancy, previous venous thromboembolism
Patient 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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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