A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease

Conditions

• Sjögren's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• DDY391 — DRUG
  DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3
• Placebo — DRUG
  Matching Placebo

Study Details

To evaluate efficacy, safety, and tolerability of DDY391 up to 52 weeks in participants with Sjögren's disease (SjD) and to determine the dose response relationship of DDY391 in participants with SjD, to support dose selection for Phase 3.

Key Dates

First listed

Jul 30, 2026

Start date

Aug 24, 2026

Status verified

Aug 2026

Primary completion

Feb 19, 2029

Completion

Mar 19, 2029

Study Design

Enrollment

344 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A- DDY391 dose level 1
  DDY391 dose level 1
• Experimental: Part A-Placebo
  Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.
• Experimental: Part B- DDY391 dose level 1
  DDY391 dose level 1
• Experimental: Part B- DDY391 dose level 2
  DDY391 dose level 2
• Experimental: Part B- DDY391 dose level 3
  DDY391 dose level 3
• Experimental: Part B- Placebo
  Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.
• Experimental: Part C- DDY391 dose level 1
  DDY391 dose level 1
• Experimental: Part C- Placebo
  Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.

Primary Outcome Measure

Part A and B: Change from baseline in ESSDAI score [ Time Frame: Baseline, Week 24 ]

Central Contacts

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

Locations (3)

Find similar trials in Tampa, FL