Hidradenitis Suppurativa
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Hidradenitis Suppurativa
ATI-450-HS-201 Enrolling

Clinical Trial for Hidradenitis Suppurativa (21 Weeks)


Age: 18 Years

Adults aged 18-70 with hidradenitis suppurativa (HS) for at least 1 year,may qualify to partcipate. Individuals must have HS lesions present in at least 2 distinct body areas, and a total abscess and inflammatory nodule (AN) count of 5 or more. In addition, qualified participants must not have a history of active skin disease other than HS that could interfere with the assessment of HS.

Participants will receive investigational oral medication (active study drug) or placebo. Study medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses maybe provided.
Total study duration lasts about 21 weeks and involves about 9 visits to the study centre.

Official Title

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 HS

ClinicalTrials.gov ID

NCT05216224

Sponsor

Aclaris Therapeutics, Inc.

Study Description

  • Brief Summary:

    Aclaris Therapeutics, Inc.

  • Condition or Disease:

    Hidradenitis Suppurativa

  • Intervention/Treatment:

    Drug: ATI-450 Drug: Placebo oral tablet
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and 70 Years (Adult,Older Adult)

  • Sexes Eligible for Study:

    All

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.


Participating Locations

COUNTRY
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United States

Participating Experts

Dr. Rocco Serrao, MD, FAAD

Dermatologist

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