Psoriatic ArthritisPhase 2NCT05511519
Study of ATI-450 vs Placebo in Patients With Moderate to Severe Psoriatic Arthritis
A Phase 2 study testing ATI-450 in people with Psoriatic Arthritis, run by Aclaris Therapeutics, Inc. at 22 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- ATI-450
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 12 Jul 2022to 3 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
Poland14 sites
Aclaris Investigational Site
Bialystok, 15-707
Aclaris Investigational Site
Bydgoszcz, 85-168
Aclaris Investigational Site
Częstochowa, 42-200
Aclaris Investigational Site
Katowice, 40-040
Aclaris Investigational Site
Katowice, 40-081
Aclaris Investigational Site
Krakow, 30-363
Aclaris Investigational Site
Krakow, 30-510
Aclaris Investigational Site
Olsztyn, 10-341
Aclaris Investigational Site
Poznan, 60-702
Aclaris Investigational Site
Stalowa Wola, 37-450
Aclaris Investigational Site
Szczecin, 70-332
Aclaris Investigational Site
Torun, 87-100
Aclaris Investigational Site
Warsaw, 04-141
Aclaris Investigational Site
Wroclaw, 50-381
United States8 sites
Aclaris Clinical Operations
Charlotte, North Carolina, 28210
Aclaris Investigational Site
Duncansville, Pennsylvania, 16635
Aclaris Clinical Operations
Freehold, New Jersey, 07728
Aclaris Investigational Site
Memphis, Tennessee, 38119
Aclaris Investigational Site
Mesquite, Texas, 75150
Aclaris Investigational Site
Miami Lakes, Florida, 33014
Aclaris Investigational Site
Perrysburg, Ohio, 43551
Aclaris Investigational Site
Tampa, Florida, 33613
About this study
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
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.
Read the 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.
- Conditions
- Psoriatic Arthritis
- Being tested
- ATI-450, Placebo Oral Tablet
- Keywords
- Arthritis, Psoriatic
- Medical subject headings
- Arthritis, Psoriatic, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATI-450Drug
Also called CDD-450
Oral, small molecule MK2 inhibitor
Placebo Oral TabletDrug
Placebo tablet manufactured to match ATI-450 in appearance
| Study group | Role | What they receive |
|---|---|---|
| ATI-450 | Experimental | ATI-450 50mg oral tablet BID Receives: Drug: ATI-450 |
| Placebo | Placebo comparator | Placebo oral tablet BID Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving ACR20 at Week 12
Measured: Baseline to Week 12
Secondary outcomes (26)
Proportion of patients with ACR 50/70 at Week 12
Measured: Baseline to Week 12
Proportion of patients with ACR 20/50/70 response at weeks 2, 4, 6, 8
Measured: Baseline to Week 12
Change from baseline in tender joint count 68 at weeks 1, 2, 4, 6, 8, 12
Measured: Baseline to Week 12
Change from baseline in swollen joint count 66 at weeks 1, 2, 4, 8, 12
Measured: Baseline to Week 12
Change from baseline in Health Assessment Questionnaire - Disability Index at weeks 2, 4, 8, 12
Measured: Baseline to Week 12
Change from baseline in patient's global assessment of disease activity at weeks 2, 4, 8, 12
Measured: Baseline to Week 12
Change from baseline in physician's global assessment of disease activity at weeks 2, 4, 8, 12
Measured: Baseline to Week 12
Change from baseline in Patients Pain VAS assessment at Weeks 2, 4, 8, 12
Measured: Baseline to Week 12
Change from baseline in high sensitivity C-reactive protein (hs-CRP) at weeks 2, 4, 8, 12
Measured: Baseline to Week 12
Change from baseline in Leeds Enthesitis Index over 12 weeks
Measured: Baseline to Week 12
Change from baseline in Leeds Dactylitis Index over 12 weeks
Measured: 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
Measured: 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
Measured: Baseline to Week 12
Proportion of patients achieving MDA at weeks 2, 4, 8, 12
Measured: Baseline to Week 12
Change from baseline in DAS28CRP at Weeks 2, 4, 8, 12
Measured: 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
Measured: Baseline to Week 12
Mean change from baseline in PASI score at weeks 2, 4, 8, 12
Measured: Baseline to Week 12
Change from baseline in Short-Form-36 Physical Component Summary at weeks 2, 4, 8, 12
Measured: Baseline to Week 12
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire at weeks 2, 4, 8, 12
Measured: Baseline to Week 12
Change from baseline in Self-Assessment of Psoriasis Symptoms Questionnaire at weeks 2, 4, 8, 12
Measured: Baseline to Week 12
Type and frequency of adverse events
Measured: Baseline to Week 12
Type and frequency of serious adverse events
Measured: Baseline to Week 12
Zunsemetinib trough concentration ng/mL
Measured: Baseline to Week 12
CDD-2164 metabolite trough concentration ng/mL
Measured: Baseline to Week 12
Zunsemetinib peak concentration (Cmax) ng/mL
Measured: Baseline to Week 12
CDD-2164 metabolite peak concentration (Cmax) ng/mL
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start12 Jul 2022
- Primary completion6 Dec 2023
- Study completion3 Jan 2024
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511519
- Sponsor's protocol ID
- ATI-450-PsA-201
- Status last verified
- Nov 2024
- First submitted
- 29 Jul 2022
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05511519
- Acronym / sponsor ID
- ATI-450-PsA-201
- Conditions
- Psoriatic Arthritis
- Keywords
- Arthritis, Psoriatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATI-450 | Experimental | Drug: ATI-450ATI-450 50mg oral tablet BID |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo oral tablet BID |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATI-450Also: CDD-450Oral, small molecule MK2 inhibitor | Drug | ATI-450 |
| Placebo Oral TabletPlacebo tablet manufactured to match ATI-450 in appearance | Drug | Placebo |
Primary outcome
Proportion of patients achieving ACR20 at Week 12
Time frame: Baseline to Week 12
26 secondary outcomes
Proportion of patients with ACR 50/70 at Week 12
Time frame: 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
Change from baseline in tender joint count 68 at weeks 1, 2, 4, 6, 8, 12
Time frame: 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
Change from baseline in Health Assessment Questionnaire - Disability Index at weeks 2, 4, 8, 12
Time frame: 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
Change from baseline in physician's global assessment of disease activity at weeks 2, 4, 8, 12
Time frame: Baseline to Week 12
Change from baseline in Patients Pain VAS assessment at Weeks 2, 4, 8, 12
Time frame: 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
Change from baseline in Leeds Enthesitis Index over 12 weeks
Time frame: Baseline to Week 12
Change from baseline in Leeds Dactylitis Index over 12 weeks
Time frame: 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
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
Proportion of patients achieving MDA at weeks 2, 4, 8, 12
Time frame: Baseline to Week 12
Change from baseline in DAS28CRP at Weeks 2, 4, 8, 12
Time frame: 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
Mean change from baseline in PASI score at weeks 2, 4, 8, 12
Time frame: 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
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire at weeks 2, 4, 8, 12
Time frame: 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
Type and frequency of adverse events
Time frame: Baseline to Week 12
Type and frequency of serious adverse events
Time frame: Baseline to Week 12
Zunsemetinib trough concentration ng/mL
Time frame: Baseline to Week 12
CDD-2164 metabolite trough concentration ng/mL
Time frame: Baseline to Week 12
Zunsemetinib peak concentration (Cmax) ng/mL
Time frame: Baseline to Week 12
CDD-2164 metabolite peak concentration (Cmax) ng/mL
Time frame: Baseline to Week 12
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATI-450 in people with Psoriatic Arthritis, run by Aclaris Therapeutics, Inc. at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Poland, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving ACR20 at Week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.