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

Primary Purpose

Hidradenitis Suppurativa

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ATI-450
Placebo oral tablet
Sponsored by
Aclaris Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis, Suppurativa, HS, Acne inversa

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ATI-450

Placebo

Arm Description

ATI-450 50mg oral tablet BID

Placebo oral tablet BID

Outcomes

Primary Outcome Measures

Efficacy measured as the change from Baseline in inflammatory nodule/abscess count at Week 12.

Secondary Outcome Measures

Percentage of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.
Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) over time for the 12-week treatment period.
Percentage of patients achieving at least a 30% reduction and at least 1 unit reduction from Baseline in the numerical rating scale (NRS30) in Patient's Global Assessment of Skin Pain at Week 12 among patients with Baseline NRS ≥3.
Change from Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HSPGA) over time for the 12-week treatment period
Change from Baseline in Dermatology Life Quality Index (DLQI) over time for the 12-week treatment period
Incidence of adverse events (AEs), serious AEs (SAEs), laboratory value abnormalities, electrocardiogram (ECG) abnormalities, vital signs abnormalities
To assess trough and 2 hour concentrations of ATI-450 and its metabolite

Full Information

First Posted
January 19, 2022
Last Updated
March 31, 2023
Sponsor
Aclaris Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05216224
Brief Title
ATI-450 vs Placebo in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 29, 2021 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
January 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aclaris Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis, Suppurativa, HS, Acne inversa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The blinded placebo drug is packaged to match the active study drug and will be stored under the same conditions.
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATI-450
Arm Type
Experimental
Arm Description
ATI-450 50mg oral tablet BID
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo oral tablet BID
Intervention Type
Drug
Intervention Name(s)
ATI-450
Other Intervention Name(s)
Zunsemetinib
Intervention Description
Oral, small molecule MK2 inhibitor
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Other Intervention Name(s)
Placebo
Intervention Description
Placebo tablet manufactured to match ATI-450 in appearance
Primary Outcome Measure Information:
Title
Efficacy measured as the change from Baseline in inflammatory nodule/abscess count at Week 12.
Time Frame
Baseline through Week 12.
Secondary Outcome Measure Information:
Title
Percentage of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.
Time Frame
Baseline through Week 12.
Title
Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) over time for the 12-week treatment period.
Time Frame
Baseline through Week 12.
Title
Percentage of patients achieving at least a 30% reduction and at least 1 unit reduction from Baseline in the numerical rating scale (NRS30) in Patient's Global Assessment of Skin Pain at Week 12 among patients with Baseline NRS ≥3.
Time Frame
Baseline through Week 12.
Title
Change from Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HSPGA) over time for the 12-week treatment period
Time Frame
Baseline through Week 12.
Title
Change from Baseline in Dermatology Life Quality Index (DLQI) over time for the 12-week treatment period
Time Frame
Baseline through Week 12.
Title
Incidence of adverse events (AEs), serious AEs (SAEs), laboratory value abnormalities, electrocardiogram (ECG) abnormalities, vital signs abnormalities
Time Frame
Baseline through Week 12.
Title
To assess trough and 2 hour concentrations of ATI-450 and its metabolite
Time Frame
Day 1, 8, and 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajay Aggarwal
Organizational Affiliation
Aclaris Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Aclaris Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Aclaris Investigational Site
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Aclaris Investigational Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Aclaris Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Aclaris Investigational Site
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Aclaris Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Aclaris Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Aclaris Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Aclaris Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Aclaris Investigational Site
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Aclaris Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Aclaris Investigational Site
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Aclaris Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Aclaris Investigational Site
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
Aclaris Investigational Site
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Aclaris Investigational Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Aclaris Investigational Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Aclaris Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Aclaris Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Aclaris Investigational Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States

12. IPD Sharing Statement

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

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