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

NCT05216224 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2026-01-07

Study results available
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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).

Conditions

Interventions

DRUG

ATI-450

Oral, small molecule MK2 inhibitor

DRUG

Placebo oral tablet

Placebo tablet manufactured to match ATI-450 in appearance

Sponsors & Collaborators

  • Aclaris Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ajay Aggarwal · Aclaris Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-29
Primary Completion
2022-12-23
Completion
2023-01-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05216224 on ClinicalTrials.gov