Recruiting
Phase 2

DDY391

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07801495

Conditions

Moderate to Severe Psoriatic Arthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

DDY391

Placebo

Study Details

Brief summary:

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.

Conditions

Moderate to Severe Psoriatic Arthritis

Study ID

NCT07801495

Start date

Oct 14, 2026

Status verified date

Sep, 2026

Completion date

Jan 12, 2029

Anticipated

Primary completion date

Dec 13, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key 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.

Key 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.

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

DDY391

DDY391

Placebo

Matching placebo

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

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

Novartis Pharmaceuticals

+41613241111

Locations

Rheumatology Associates of South Texas

Recruiting

San Antonio, Texas, United States, 78251

Contacts

Veronica Gonzales

VGonzales@biopharmainfo.net

Principal Investigator:

Jane Barbosa Ayala

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-09-17.