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DDY391 · 2 trials · 2 indications
To evaluate the efficacy of DDY391 versus placebo through achievement of ACR 50. ACR 50 is a validated tool for assessing RA disease activity.
To demonstrate the dose-response relationship of DDY391 compared to placebo in bDMARD-IR participants.
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a validated tool for assessing disease activity in SjD. Score range is 0-123. Higher scores on the ESSDAI scale are associated with poorer health states. A negative change from baseline indicates improvement in disease status.
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a validated disease outcome measure for SjD. It consists of three domains of dryness, pain, and fatigue. The participant will assess severity of symptoms they experienced over the last 14 days on a single 0-10 numerical rating scale for each of the three domains. The ESSPRI score is defined as the mean of scores from the three scales: (dryness + pain + fatigue) /3. The total ESSPRI score ranges from 0 (no symptoms) to 10 (maximal symptom severity).
| Arm | Type | Description |
|---|---|---|
| Part A: DDY391-Schedule 1 Dose A | EXPERIMENTAL | Participants will receive DDY391 Schedule 1 Dose A. |
| Part A: Placebo Schedule 1 | PLACEBO_COMPARATOR | Participants will receive matching placebo Schedule 1. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Part A- DDY391 dose level 1 | EXPERIMENTAL | DDY391 dose level 1 |
| Part A-Placebo | EXPERIMENTAL | Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2. |
| Part B- DDY391 dose level 1 | EXPERIMENTAL | DDY391 dose level 1 |
| Part B- DDY391 dose level 2 | EXPERIMENTAL | DDY391 dose level 2 |
| Part B- DDY391 dose level 3 | EXPERIMENTAL | DDY391 dose level 3 |
| Part B- Placebo | EXPERIMENTAL | Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2. |
| Part C- DDY391 dose level 1 | EXPERIMENTAL | DDY391 dose level 1 |
| Part C- Placebo | EXPERIMENTAL | Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2. |
| Name | Type | Description |
|---|---|---|
| DDY391 | DRUG | DDY391 |
| Placebo | DRUG | Matching placebo |
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 o...
DDY391 is an investigational small molecule being developed by Novartis AG for moderate to severe psoriatic arthritis and Sjögren's disease. It is currently in Phase 2 clinical development and has not been approved by the FDA. Both programs are actively recruiting participants in randomized, double-blind, placebo-controlled trials.
DDY391 is being studied for the treatment of moderate to severe psoriatic arthritis and Sjögren's disease. Both are immune-mediated conditions, and the drug is in Phase 2 development for each indication. It is investigational and has not received regulatory approval for any use.
DDY391 is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is running the clinical program, including a Phase 2 psoriatic arthritis trial and a Phase 2a/b Sjögren's disease trial.
DDY391 is in Phase 2 clinical development. Novartis is running a Phase 2 study in moderate to severe psoriatic arthritis and a Phase 2a/b study in Sjögren's disease. The drug is investigational and has not been approved by the FDA.
DDY391 is being evaluated in two recruiting trials. NCT07801495 is a Phase 2 study in moderate to severe psoriatic arthritis enrolling 220 participants in the United States. NCT07737743 is a Phase 2a/b study in Sjögren's disease enrolling 344 participants across the United States, Australia, Canada, China, and Israel.
DDY391 is a small molecule given as a systemic therapy in its clinical trials. Both the psoriatic arthritis and Sjögren's disease studies are randomized, double-blind, and placebo-controlled, enrolling adults 18 years and older. The trials do not select participants based on a biomarker.