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

NCT07801495 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: CDDY391A122012025-524512-102025
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this Phase 2a/b study is:

1. 1.to evaluate the efficacy, safety and tolerability of DDY391 in participants with psoriatic arthritis (PsA).
2. 2.to determine the dose-response relationship of DDY391 in participants with PsA to support dose selection for Phase 3.

Conditions

Moderate to Severe Psoriatic Arthritis

Keywords

Psoriatic arthritis; Psoriasis; bDMARD; csDMARD; ACR50; Molecular Glue Degrader; VAV1

Outcome Measures

Primary Outcomes (2)

• Part A: Number of participants achieving American College of Rheumatology 50 (ACR50) response

  To evaluate the efficacy of DDY391 versus placebo through achievement of ACR 50. ACR 50 is a validated tool for assessing RA disease activity.

  Week 12

• Part A and B: Number of participants achieving American College of Rheumatology 50 (ACR50) response

  To demonstrate the dose-response relationship of DDY391 compared to placebo in bDMARD-IR participants.

  Week 12

Secondary Outcomes (2)

• 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

Study Arms (8)

Part A: DDY391-Schedule 1 Dose A

EXPERIMENTAL

Participants will receive DDY391 Schedule 1 Dose A.

Drug: DDY391

Part A: Placebo Schedule 1

PLACEBO COMPARATOR

Participants will receive matching placebo Schedule 1.

Drug: Placebo

Part B: DDY391- Schedule 1 Dose A

EXPERIMENTAL

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).

Drug: DDY391

Part B: DDY391- Schedule 1 Dose B

EXPERIMENTAL

Participants will receive DDY391 Schedule 1 Dose B. Based on treatment response, participants will then either continue receiving DDY391 or switch to local SOC.

Drug: DDY391

Part B: DDY391- Schedule 1 Dose C

EXPERIMENTAL

Participants will receive DDY391 Schedule 1 Dose C. Based on treatment response, participants will then either continue receiving DDY391 or switch to local SOC.

Drug: DDY391

Part B: Placebo Schedule 1

EXPERIMENTAL

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.

Drug: Placebo

Part B: DDY391- Schedule 2 Dose C

EXPERIMENTAL

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.

Drug: DDY391

Part B: Placebo Schedule 2

EXPERIMENTAL

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.

Drug: Placebo

Interventions

DDY391 DRUG

DDY391

Part A: DDY391-Schedule 1 Dose A; Part B: DDY391- Schedule 1 Dose A; Part B: DDY391- Schedule 1 Dose B; Part B: DDY391- Schedule 1 Dose C; Part B: DDY391- Schedule 2 Dose C

Placebo DRUG

Matching placebo

Part A: Placebo Schedule 1; Part B: Placebo Schedule 1; Part B: Placebo Schedule 2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Precision Comprehensive Research

Colleyville, Texas, 76034, United States

RECRUITING

Rheumatology Associates of South Texas

San Antonio, Texas, 78251, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start (Estimated): October 14, 2026
• Primary Completion (Estimated): December 13, 2028
• Study Completion (Estimated): January 12, 2029
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (2)