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

ConditionPrimary Sjogren's Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVor Biopharma

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female aged 18 to 75 years of age (both inclusive) at screening

Participants must meet the 2016 American College of Rheumatology (ACR)/EULAR classification criteria for primary Sjogren's Syndrome at the time of screening.

ESSDAI ≥5 at screening (score calculated excluding renal, pulmonary and neurological domains)

Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at the Screening Visit.

Disqualifiers

Participants who have a systemic autoimmune disease other than Primary Sjogren's Disease, such as rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis, that can better explain the majority of the symptoms (i.e., secondary Sjogren's Disease)

Participants who have another autoimmune disease or inflammatory condition that could interfere with assessment of response of Primary Sjogren's Disease to therapy (e.g., systemic sclerosis, inflammatory bowel disease, gout).

Participants with severe fibromyalgia that could interfere with the assessment of response of Primary Sjogren's Disease to therapy

Active life-threatening or organ-threatening complications of Primary Sjogren's Disease at the time of screening based on investigator evaluation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Telitacicept

    Biological/Vaccine

    Subcutaneous injection

  • Placebo

    Drug

    Subcutaneous injection

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: TelitaciceptExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.

Time frame
Week 48

Secondary outcomes

1

To evaluate the efficacy of telitacicept versus placebo at Week 48 in the treatment of adult participants with pSD.

To evaluate the efficacy of telitacicept versus placebo at Week 48 in the treatment of adult participants with pSD.

Time frame
Week 48
2

To evaluate the efficacy of telitacicept versus placebo in improving glandular function during the trial.

Change from baseline in the stimulated whole salivary flow at Week 48.

Time frame
Week 48
3

To evaluate the effect of telitacicept versus placebo in improving patient-reported outcomes (i.e., how participants feel and function) during the trial.

Change from baseline in the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score at Week 48

Time frame
Week 48
4

To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the physician's global assessment of disease activity (Physician GDA) score at Week 48

Change from baseline in the physician's global assessment of disease activity (Physician GDA) score at Week 48

Time frame
Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vor Biopharma

Lead sponsor

Source ClinicalTrials.gov
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