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

NCT ID: NCT05216224

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-29

Study Completion Date

2023-01-24

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Hidradenitis Suppurativa

Keywords

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Hidradenitis Suppurativa HS Acne inversa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, placebo-controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The blinded placebo drug is packaged to match the active study drug and will be stored under the same conditions.

Study Groups

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ATI-450

ATI-450 50mg oral tablet BID

Group Type EXPERIMENTAL

ATI-450

Intervention Type DRUG

Oral, small molecule MK2 inhibitor

Placebo

Placebo oral tablet BID

Group Type EXPERIMENTAL

Placebo oral tablet

Intervention Type DRUG

Placebo tablet manufactured to match ATI-450 in appearance

Interventions

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ATI-450

Oral, small molecule MK2 inhibitor

Intervention Type DRUG

Placebo oral tablet

Placebo tablet manufactured to match ATI-450 in appearance

Intervention Type DRUG

Other Intervention Names

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Zunsemetinib Placebo

Eligibility Criteria

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Inclusion Criteria

* Able to comprehend and be willing to sign the Institutional Review Board (IRB)-approved patient informed consent form 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aclaris Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ajay Aggarwal

Role: STUDY_DIRECTOR

Aclaris Therapeutics, Inc.

Locations

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Aclaris Investigational Site

Birmingham, Alabama, United States

Site Status

Aclaris Investigational Site

Fort Smith, Arkansas, United States

Site Status

Aclaris Investigational Site

Encino, California, United States

Site Status

Aclaris Investigational Site

San Francisco, California, United States

Site Status

Aclaris Investigational Site

Thousand Oaks, California, United States

Site Status

Aclaris Investigational Site

Boca Raton, Florida, United States

Site Status

Aclaris Investigational Site

Hollywood, Florida, United States

Site Status

Aclaris Investigational Site

Tampa, Florida, United States

Site Status

Aclaris Investigational Site

Marietta, Georgia, United States

Site Status

Aclaris Investigational Site

Sandy Springs, Georgia, United States

Site Status

Aclaris Investigational Site

Metairie, Louisiana, United States

Site Status

Aclaris Investigational Site

Fort Gratiot, Michigan, United States

Site Status

Aclaris Investigational Site

Charlotte, North Carolina, United States

Site Status

Aclaris Investigational Site

Athens, Ohio, United States

Site Status

Aclaris Investigational Site

Mason, Ohio, United States

Site Status

Aclaris Investigational Site

Hershey, Pennsylvania, United States

Site Status

Aclaris Investigational Site

Anderson, South Carolina, United States

Site Status

Aclaris Investigational Site

Nashville, Tennessee, United States

Site Status

Aclaris Investigational Site

Houston, Texas, United States

Site Status

Aclaris Investigational Site

Sugar Land, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ATI-450-HS-201

Identifier Type: -

Identifier Source: org_study_id