Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease

Conditions

• Primary Sjogren's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Telitacicept — BIOLOGICAL
  Subcutaneous injection
• Placebo — DRUG
  Subcutaneous injection

Study Details

Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)

Key Dates

Start date

Feb 26, 2026

Status verified

Mar 2026

Primary completion

Dec 31, 2028

Completion

Jan 31, 2029

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Telitacicept
  Telitacicept
• Placebo Comparator: Placebo
  Placebo

Primary Outcome Measure

To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48. [ Time Frame: Week 48 ]

Central Contacts

• Jeremy Sokolove
  6176556580
  [email protected]

Locations (26)

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