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

November 22, 2024 updated by: Aclaris Therapeutics, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Poland
      • Białystok, Poland, 15-707
        • Aclaris Investigational Site
      • Bydgoszcz, Poland, 85-168
        • Aclaris Investigational Site
      • Częstochowa, Poland, 42-200
        • Aclaris Investigational Site
      • Katowice, Poland, 40-040
        • Aclaris Investigational Site
      • Katowice, Poland, 40-081
        • Aclaris Investigational Site
      • Kraków, Poland, 30-363
        • Aclaris Investigational Site
      • Kraków, Poland, 30-510
        • Aclaris Investigational Site
      • Olsztyn, Poland, 10-341
        • Aclaris Investigational Site
      • Poznań, Poland, 60-702
        • Aclaris Investigational Site
      • Stalowa Wola, Poland, 37-450
        • Aclaris Investigational Site
      • Szczecin, Poland, 70-332
        • Aclaris Investigational Site
      • Toruń, Poland, 87-100
        • Aclaris Investigational Site
      • Warszawa, Poland, 04-141
        • Aclaris Investigational Site
      • Wrocław, Poland, 50-381
        • Aclaris Investigational Site
  • United States
    • Florida
      • Miami Lakes, Florida, United States, 33014
        • Aclaris Investigational Site
      • Tampa, Florida, United States, 33613
        • Aclaris Investigational Site
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Aclaris Clinical Operations
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Aclaris Clinical Operations
    • Ohio
      • Perrysburg, Ohio, United States, 43551
        • Aclaris Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Aclaris Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Aclaris Investigational Site
    • Texas
      • Mesquite, Texas, United States, 75150
        • Aclaris Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ATI-450
ATI-450 50mg oral tablet BID
Drug: ATI-450
Oral, small molecule MK2 inhibitor
Other Names:
  • CDD-450
Placebo Comparator: Placebo
Placebo oral tablet BID
Drug: Placebo Oral Tablet
Placebo tablet manufactured to match ATI-450 in appearance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of patients achieving ACR20 at Week 12
Time Frame: Baseline to Week 12
Baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of patients with ACR 50/70 at Week 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Proportion of patients with ACR 20/50/70 response at weeks 2, 4, 6, 8
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from baseline in tender joint count 68 at weeks 1, 2, 4, 6, 8, 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from baseline in swollen joint count 66 at weeks 1, 2, 4, 8, 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from baseline in Health Assessment Questionnaire - Disability Index at weeks 2, 4, 8, 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from baseline in patient's global assessment of disease activity at weeks 2, 4, 8, 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from baseline in physician's global assessment of disease activity at weeks 2, 4, 8, 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from baseline in Patients Pain VAS assessment at Weeks 2, 4, 8, 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from baseline in high sensitivity C-reactive protein (hs-CRP) at weeks 2, 4, 8, 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from baseline in Leeds Enthesitis Index over 12 weeks
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from baseline in Leeds Dactylitis Index over 12 weeks
Time Frame: Baseline to Week 12
Baseline to Week 12
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
Baseline to Week 12
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
Baseline to Week 12
Proportion of patients achieving MDA at weeks 2, 4, 8, 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from baseline in DAS28CRP at Weeks 2, 4, 8, 12
Time Frame: Baseline to Week 12
Baseline to Week 12
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
Baseline to Week 12
Mean change from baseline in PASI score at weeks 2, 4, 8, 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from baseline in Short-Form-36 Physical Component Summary at weeks 2, 4, 8, 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire at weeks 2, 4, 8, 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from baseline in Self-Assessment of Psoriasis Symptoms Questionnaire at weeks 2, 4, 8, 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Type and frequency of adverse events
Time Frame: Baseline to Week 12
Baseline to Week 12
Type and frequency of serious adverse events
Time Frame: Baseline to Week 12
Baseline to Week 12
Zunsemetinib trough concentration ng/mL
Time Frame: Baseline to Week 12
Baseline to Week 12
CDD-2164 metabolite trough concentration ng/mL
Time Frame: Baseline to Week 12
Baseline to Week 12
Zunsemetinib peak concentration (Cmax) ng/mL
Time Frame: Baseline to Week 12
Baseline to Week 12
CDD-2164 metabolite peak concentration (Cmax) ng/mL
Time Frame: Baseline to Week 12
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aclaris Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 3, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATI-450-PsA-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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