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Study of ATI-450 vs Placebo in Patients With Moderate to Severe Psoriatic Arthritis

Primary Purpose

Psoriatic Arthritis

Status
Recruiting
Phase
Phase 2
Locations
International
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 Psoriatic Arthritis focused on measuring Arthritis, Psoriatic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of PsA with symptom onset at least 6 months before the Screening Visit and fulfilment of the Classification Criteria for PsA.

  • Patient has moderate-to-severe PsA at Screening and Randomization Visits defined as

    • ≥3 tender joints (based on 68 joint counts) and
    • ≥3 swollen joints (based on 66 joint counts).
  • Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.

Exclusion Criteria:

  • Any arthritis with onset before age 17 years, or current diagnosis of inflammatory joint disease other than PsA, or other immunological disease (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).
  • Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results, eg, cirrhosis, previous malignancy, previous venous thromboembolism.
  • Any clinically significant laboratory abnormality that would affect interpretation of study data or safety of the patient's participation in the study, per judgment of the investigator.

Sites / Locations

  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Clinical Operations
  • Aclaris Clinical Operations
  • Aclaris Investigational Site
  • Aclaris Investigational SiteRecruiting
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational SiteRecruiting
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational SiteRecruiting
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational SiteRecruiting
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ATI-450

Placebo

Arm Description

ATI-450 50mg oral tablet BID

Placebo oral tablet BID

Outcomes

Primary Outcome Measures

Proportion of patients achieving ACR20 at Week 12

Secondary Outcome Measures

Proportion of patients with ACR 50/70 at Week 12
Proportion of patients with ACR 20/50/70 response at weeks 2, 4, 6, 8
Change from baseline in tender joint count 68 at weeks 1, 2, 4, 6, 8, 12
Change from baseline in swollen joint count 66 at weeks 1, 2, 4, 8, 12
Change from baseline in Health Assessment Questionnaire - Disability Index at weeks 2, 4, 8, 12
Change from baseline in patient's global assessment of disease activity at weeks 2, 4, 8, 12
Change from baseline in physician's global assessment of disease activity at weeks 2, 4, 8, 12
Change from baseline in Patients Pain VAS assessment at Weeks 2, 4, 8, 12
Change from baseline in high sensitivity C-reactive protein (hs-CRP) at weeks 2, 4, 8, 12
Change from baseline in Leeds Enthesitis Index over 12 weeks
Change from baseline in Leeds Dactylitis Index over 12 weeks
Proportion 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 Daily Assessment of Skin Pain at Weeks 2, 4, 8, 12 among patients with Baseline NRS ≥3
Proportion of patients achieving a sIGA of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline among those with a baseline investigator's global assessment of at least 3 over 12 weeks
Proportion of patients achieving MDA at weeks 2, 4, 8, 12
Change from baseline in DAS28CRP at Weeks 2, 4, 8, 12
Psoriasis Area Severity Index (PASI) 50/75/90 response (for patients with ≥3% body surface area psoriasis at baseline) at Week 12
Mean change from baseline in PASI score at weeks 2, 4, 8, 12
Change from baseline in Short-Form-36 Physical Component Summary at weeks 2, 4, 8, 12
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire at weeks 2, 4, 8, 12
Change from baseline in Self-Assessment of Psoriasis Symptoms Questionnaire at weeks 2, 4, 8, 12
Type and frequency of adverse events
Type and frequency of serious adverse events
Zunsemetinib trough concentration ng/mL
CDD-2164 metabolite trough concentration ng/mL
Zunsemetinib peak concentration (Cmax) ng/mL
CDD-2164 metabolite peak concentration (Cmax) ng/mL

Full Information

First Posted
July 29, 2022
Last Updated
June 6, 2023
Sponsor
Aclaris Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05511519
Brief Title
Study of ATI-450 vs Placebo in Patients With Moderate to Severe Psoriatic Arthritis
Official Title
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zunsemetinib vs Placebo in Patients With Moderate-to-Severe Active Psoriatic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

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
No

5. Study Description

Brief Summary
This is a Phase 2a study to investigate the efficacy, safety, tolerability, PK, and PD of ATI-450 versus placebo in patients with moderate to severe psoriatic arthritis.
Detailed Description
This is a Phase 2a, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, tolerability, PK, and PD of ATI-450 versus placebo in patients with moderate to severe psoriatic arthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Arthritis, Psoriatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
70 (Anticipated)

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
Placebo Comparator
Arm Description
Placebo oral tablet BID
Intervention Type
Drug
Intervention Name(s)
ATI-450
Other Intervention Name(s)
CDD-450
Intervention Description
Oral, small molecule MK2 inhibitor
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo tablet manufactured to match ATI-450 in appearance
Primary Outcome Measure Information:
Title
Proportion of patients achieving ACR20 at Week 12
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Proportion of patients with ACR 50/70 at Week 12
Time Frame
Baseline to Week 12
Title
Proportion of patients with ACR 20/50/70 response at weeks 2, 4, 6, 8
Time Frame
Baseline to Week 12
Title
Change from baseline in tender joint count 68 at weeks 1, 2, 4, 6, 8, 12
Time Frame
Baseline to Week 12
Title
Change from baseline in swollen joint count 66 at weeks 1, 2, 4, 8, 12
Time Frame
Baseline to Week 12
Title
Change from baseline in Health Assessment Questionnaire - Disability Index at weeks 2, 4, 8, 12
Time Frame
Baseline to Week 12
Title
Change from baseline in patient's global assessment of disease activity at weeks 2, 4, 8, 12
Time Frame
Baseline to Week 12
Title
Change from baseline in physician's global assessment of disease activity at weeks 2, 4, 8, 12
Time Frame
Baseline to Week 12
Title
Change from baseline in Patients Pain VAS assessment at Weeks 2, 4, 8, 12
Time Frame
Baseline to Week 12
Title
Change from baseline in high sensitivity C-reactive protein (hs-CRP) at weeks 2, 4, 8, 12
Time Frame
Baseline to Week 12
Title
Change from baseline in Leeds Enthesitis Index over 12 weeks
Time Frame
Baseline to Week 12
Title
Change from baseline in Leeds Dactylitis Index over 12 weeks
Time Frame
Baseline to Week 12
Title
Proportion 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 Daily Assessment of Skin Pain at Weeks 2, 4, 8, 12 among patients with Baseline NRS ≥3
Time Frame
Baseline to Week 12
Title
Proportion of patients achieving a sIGA of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline among those with a baseline investigator's global assessment of at least 3 over 12 weeks
Time Frame
Baseline to Week 12
Title
Proportion of patients achieving MDA at weeks 2, 4, 8, 12
Time Frame
Baseline to Week 12
Title
Change from baseline in DAS28CRP at Weeks 2, 4, 8, 12
Time Frame
Baseline to Week 12
Title
Psoriasis Area Severity Index (PASI) 50/75/90 response (for patients with ≥3% body surface area psoriasis at baseline) at Week 12
Time Frame
Baseline to Week 12
Title
Mean change from baseline in PASI score at weeks 2, 4, 8, 12
Time Frame
Baseline to Week 12
Title
Change from baseline in Short-Form-36 Physical Component Summary at weeks 2, 4, 8, 12
Time Frame
Baseline to Week 12
Title
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire at weeks 2, 4, 8, 12
Time Frame
Baseline to Week 12
Title
Change from baseline in Self-Assessment of Psoriasis Symptoms Questionnaire at weeks 2, 4, 8, 12
Time Frame
Baseline to Week 12
Title
Type and frequency of adverse events
Time Frame
Baseline to Week 12
Title
Type and frequency of serious adverse events
Time Frame
Baseline to Week 12
Title
Zunsemetinib trough concentration ng/mL
Time Frame
Baseline to Week 12
Title
CDD-2164 metabolite trough concentration ng/mL
Time Frame
Baseline to Week 12
Title
Zunsemetinib peak concentration (Cmax) ng/mL
Time Frame
Baseline to Week 12
Title
CDD-2164 metabolite peak concentration (Cmax) ng/mL
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of PsA with symptom onset at least 6 months before the Screening Visit and fulfilment of the Classification Criteria for PsA. Patient has moderate-to-severe PsA at Screening and Randomization Visits defined as ≥3 tender joints (based on 68 joint counts) and ≥3 swollen joints (based on 66 joint counts). Diagnosis of active plaque psoriasis or documented history of plaque psoriasis. Exclusion Criteria: Any arthritis with onset before age 17 years, or current diagnosis of inflammatory joint disease other than PsA, or other immunological disease (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results, eg, cirrhosis, previous malignancy, previous venous thromboembolism. Any clinically significant laboratory abnormality that would affect interpretation of study data or safety of the patient's participation in the study, per judgment of the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Engle
Phone
1-267-691-2563
Email
clinicaloperations@aclaristx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Salamea
Phone
1-484-540-6296
Email
clinicaloperations@aclaristx.com
Facility Information:
Facility Name
Aclaris Investigational Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Clinical Operations
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Clinical Operations
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Białystok
ZIP/Postal Code
15-707
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Częstochowa
ZIP/Postal Code
42-200
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Kraków
ZIP/Postal Code
30-363
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Olsztyn
ZIP/Postal Code
10-341
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Poznań
ZIP/Postal Code
60-702
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Stalowa Wola
ZIP/Postal Code
37-450
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Szczecin
ZIP/Postal Code
70-332
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933
Facility Name
Aclaris Investigational Site
City
Wrocław
ZIP/Postal Code
50-381
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aclaris Clinical Operations
Phone
484-324-7933

12. IPD Sharing Statement

Learn more about this trial

Study of ATI-450 vs Placebo in Patients With Moderate to Severe Psoriatic Arthritis

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