A Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis

Conditions

• Moderate to Severe Psoriatic Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• DDY391 — DRUG
  DDY391
• Placebo — DRUG
  Matching placebo

Study Details

The purpose of this Phase 2a/b study is: 1. to evaluate the efficacy, safety and tolerability of DDY391 in participants with psoriatic arthritis (PsA). 2. to determine the dose-response relationship of DDY391 in participants with PsA to support dose selection for Phase 3.

Key Dates

First listed

Sep 3, 2026

Start date

Oct 14, 2026

Status verified

Sep 2026

Primary completion

Dec 13, 2028

Completion

Jan 12, 2029

Study Design

Enrollment

220 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A: DDY391-Schedule 1 Dose A
  Participants will receive DDY391 Schedule 1 Dose A.
• Placebo Comparator: Part A: Placebo Schedule 1
  Participants will receive matching placebo Schedule 1.
• Experimental: 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).
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.

Primary Outcome Measure

Part A: Number of participants achieving American College of Rheumatology 50 (ACR50) response [ Time Frame: Week 12 ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111

Locations (1)

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