NCT05216224

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 29, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2023

Completed
3 years until next milestone

Results Posted

Study results publicly available

January 7, 2026

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

January 19, 2022

Results QC Date

December 15, 2025

Last Update Submit

December 15, 2025

Conditions

Hidradenitis Suppurativa

Keywords

HidradenitisSuppurativaHSAcne inversa

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 12

    AN count was the sum of number of abscess and inflammatory nodules across anatomical regions. The least square (LS) mean change from baseline in the count at Week 12 was estimated from the Mixed Model Repeated Measures (MMRM) model.

    Baseline, Week 12

Secondary Outcomes (7)

  • Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 12

    Week 12

  • Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) at Week 12

    Baseline, Week 12

  • Percentage of Participants Achieving NRS30

    Week 12

  • Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HSPGA) at Week 12

    Baseline, Week 12

  • Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12

    Baseline, Week 12

  • +2 more secondary outcomes

Study Arms (2)

ATI-450

EXPERIMENTAL

ATI-450 50 milligrams (mg) oral tablet twice daily (BID)

Drug: ATI-450

Placebo

EXPERIMENTAL

Placebo oral tablet BID

Drug: Placebo oral tablet

Interventions

ATI-450DRUG

Oral, small molecule MK2 inhibitor

Also known as: Zunsemetinib
ATI-450
Placebo oral tabletDRUG

Placebo tablet manufactured to match ATI-450 in appearance

Also known as: Placebo
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Aclaris Investigational Site

Birmingham, Alabama, 35244, United States

Location

Aclaris Investigational Site

Fort Smith, Arkansas, 72916, United States

Location

Aclaris Investigational Site

Encino, California, 91436, United States

Location

Aclaris Investigational Site

San Francisco, California, 94115, United States

Location

Aclaris Investigational Site

Thousand Oaks, California, 91436, United States

Location

Aclaris Investigational Site

Boca Raton, Florida, 33486, United States

Location

Aclaris Investigational Site

Hollywood, Florida, 33021, United States

Location

Aclaris Investigational Site

Tampa, Florida, 33613, United States

Location

Aclaris Investigational Site

Marietta, Georgia, 30060, United States

Location

Aclaris Investigational Site

Sandy Springs, Georgia, 30328, United States

Location

Aclaris Investigational Site

Metairie, Louisiana, 70006, United States

Location

Aclaris Investigational Site

Fort Gratiot, Michigan, 48059, United States

Location

Aclaris Investigational Site

Charlotte, North Carolina, 28277, United States

Location

Aclaris Investigational Site

Athens, Ohio, 45701, United States

Location

Aclaris Investigational Site

Mason, Ohio, 45040, United States

Location

Aclaris Investigational Site

Hershey, Pennsylvania, 17033, United States

Location

Aclaris Investigational Site

Anderson, South Carolina, 29621, United States

Location

Aclaris Investigational Site

Nashville, Tennessee, 37215, United States

Location

Aclaris Investigational Site

Houston, Texas, 77054, United States

Location

Aclaris Investigational Site

Sugar Land, Texas, 77478, United States

Location

MeSH Terms

Conditions

Hidradenitis SuppurativaHidradenitis

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesSweat Gland Diseases

Results Point of Contact

Title
Clinical Operations
Organization
Aclaris Therapeutics, Inc.
clinicaloperations@aclaristx.com
1-833-225-2747

Study Officials

  • Ajay Aggarwal

    Aclaris Therapeutics, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The blinded placebo drug is packaged to match the active study drug and will be stored under the same conditions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, placebo-controlled study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2022

First Posted

January 31, 2022

Study Start

December 29, 2021

Primary Completion

December 23, 2022

Study Completion

January 24, 2023

Last Updated

January 7, 2026

Results First Posted

January 7, 2026

Record last verified: 2025-12

Locations

US(20)