A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2a/b Study Assessing the Efficacy, Safety and Tolerability of DDY391 in Participants With Active Moderate to Severe Psoriatic Arthritis
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Part A: Number of participants achieving American College of Rheumatology 50 (ACR50) response
Study Overview
Brief Summary
The purpose of this Phase 2a/b study is:
- to evaluate the efficacy, safety and tolerability of DDY391 in participants with psoriatic arthritis (PsA).
- to determine the dose-response relationship of DDY391 in participants with PsA to support dose selection for Phase 3.
Detailed Description
This study is a Phase 2a/b, randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy, safety, tolerability and dose-response relationship of DDY391 in participants with active moderate to severe PsA.
The study is composed of two sequential parts:
- Part A to evaluate efficacy, safety and tolerability of DDY391 compared with placebo.
- Part B to determine the dose-response relationship of multiple doses of DDY391 compared with placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female or male participants at least 18 years of age.
- •Diagnosis of PsA and meeting classification criteria for Psoriatic arthritis (CASPAR) at screening.
- •Moderate to severe PsA at screening and baseline.
Exclusion Criteria
- •Presence of inflammatory conditions other than psoriasis or PsA including but not limited to those associated with arthralgia or arthritis (e.g., rheumatoid arthritis, systemic lupus erythematosus, scleroderma, sarcoidosis) or presence of fibromyalgia or osteoarthritis with articular symptoms.
- •Use of bDMARD treatment within 4 weeks or 5 half-lives of randomization, whichever is longer
- •Prior use of JAK inhibitors or TYK2 inhibitors (e.g., deucravacitinib). Prior use of apremilast is allowed but must not be taken within 4 weeks of baseline.
- •Previous treatment with any cell-depleting therapies, including but not limited to anti-CD20, unless ≥ 12 months prior to baseline.
- •History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
- •Any active viral, bacterial or other infections at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infections.
- •Other protocol-defined inclusion/exclusion criteria may apply.
Arms & Interventions
Part A: DDY391-Schedule 1 Dose A
Participants will receive DDY391 Schedule 1 Dose A.
Intervention: DDY391 (Drug)
Part A: Placebo Schedule 1
Participants will receive matching placebo Schedule 1.
Intervention: Placebo (Drug)
Part B: DDY391- Schedule 1 Dose A
Participants will receive DDY391 Schedule 1 Dose A. Based on treatment response, participants will then either continue receiving DDY391 or switch to local standard of care (SOC).
Intervention: DDY391 (Drug)
Part B: DDY391- Schedule 1 Dose B
Participants will receive DDY391 Schedule 1 Dose B. Based on treatment response, participants will then either continue receiving DDY391 or switch to local SOC.
Intervention: DDY391 (Drug)
Part B: DDY391- Schedule 1 Dose C
Participants will receive DDY391 Schedule 1 Dose C. Based on treatment response, participants will then either continue receiving DDY391 or switch to local SOC.
Intervention: DDY391 (Drug)
Part B: Placebo Schedule 1
Participants will receive matching placebo Schedule 1. Based on treatment response, participants will then either switch to DDY391 Schedule 1 Dose A or receive local SOC.
Intervention: Placebo (Drug)
Part B: DDY391- Schedule 2 Dose C
Participants will receive DDY391 Schedule 2 Dose C. Based on treatment response, participants will then either switch to DDY391 Schedule 1 Dose A or receive local SOC.
Intervention: DDY391 (Drug)
Part B: Placebo Schedule 2
Participants will receive matching placebo Schedule 2. Based on treatment response, participants will then either switch to DDY391 Schedule 1 Dose A or receive local SOC.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Part A: Number of participants achieving American College of Rheumatology 50 (ACR50) response
Time Frame: Week 12
To evaluate the efficacy of DDY391 versus placebo through achievement of ACR 50. ACR 50 is a validated tool for assessing RA disease activity.
Part A and B: Number of participants achieving American College of Rheumatology 50 (ACR50) response
Time Frame: Week 12
To demonstrate the dose-response relationship of DDY391 compared to placebo in bDMARD-IR participants.
Secondary Outcomes
- Part B: Number of participants achieving American College of Rheumatology 50 (ACR50) response(Week 12)
- Part A and Part B: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)(From first dose through Week 12)