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DDY391 · 1 trial · 1 indication
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 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 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
| Placebo | DRUG | Matching Placebo |
Key Inclusion Criteria: • Participants must have a diagnosis of SjD according to the ACR/EULAR 2016 classification criteria at screening: \- Positive anti-Ro (SSA) antibodies at screening. Participants negative for anti-Ro/SSA antibodies are eligible if they have documented previous biopsy showing...
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DDY391 is an investigational small molecule being developed for the treatment of Sjögren's Disease, an autoimmune condition that primarily affects moisture-producing glands. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
DDY391 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's efficacy, safety, and tolerability in patients with Sjögren's Disease.
DDY391 is currently in Phase 2 clinical development. It is being studied in a Phase 2a/b trial designed to assess its efficacy, safety, and tolerability in participants with Sjögren's Disease. The drug is investigational and has not yet received regulatory approval.
DDY391 is being evaluated in a single Phase 2a/b clinical trial registered as NCT07737743. This randomized, double-blind, controlled study aims to enroll 344 participants aged 18 years and older with Sjögren's Disease. The trial is not yet recruiting participants.
DDY391 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Sjögren's Disease. The ongoing clinical trial is designed to assess its efficacy, safety, and tolerability, but the drug has not yet been authorized for commercial use.