A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept in Adult Participants With Active Primary Sjögren's Disease

Plain English Summary

Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease is a Phase 3 clinical trial sponsored by Vor Biopharma studying Primary Sjogren's Disease. Tests Telitacicept, a new drug, to see if it helps people with active Primary Sjögren's Disease. For adults aged 18 to 75 who have symptoms of Primary Sjögren's Disease and meet specific health criteria. Participation involves taking weekly injections of Telitacicept or a placebo for 48 weeks. Alternative treatments include other medications or therapies prescribed by your doctor. The trial aims to enroll 250 participants.

Official Summary

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

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible participants are adults aged 18 to 75 with Primary Sjögren's Disease and certain health criteria. Excluded are those with other autoimmune diseases or severe health issues that could interfere with the study. Participants must be able to travel to one of the study locations in the US for regular check-ups. This trial is studying Primary Sjogren's Disease, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures the change in disease activity score, indicating how well the drug works to reduce symptoms. The specific primary outcome measures are: 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. (Week 48). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to fill a treatment gap for those with active Primary Sjögren's Disease, offering a potential new therapy. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Primary Sjogren's Disease, where improved treatment options are needed.

Investor Insight

The large market size and lack of effective treatments make this trial significant, with a high probability of approval. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if you meet the eligibility criteria and if this trial is right for you. Participation involves weekly injections and regular check-ups at one of the study locations. This trial is currently recruiting participants. The trial is being conducted at 5 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 250 participants

Interventions

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

Primary Outcomes

• 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. (Week 48)

Secondary Outcomes

• To evaluate the efficacy of telitacicept versus placebo at Week 48 in the treatment of adult participants with pSD. (Week 48)
• To evaluate the efficacy of telitacicept versus placebo in improving glandular function during the trial. (Week 48)
• To evaluate the effect of telitacicept versus placebo in improving patient-reported outcomes (i.e., how participants feel and function) during the trial. (Week 48)
• 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 (Week 48)
• To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 48 (Week 48)

Full Eligibility Criteria

Inclusion Criteria:

1. Male or female aged 18 to 75 years of age (both inclusive) at screening
2. Participants must meet the 2016 American College of Rheumatology (ACR)/EULAR classification criteria for primary Sjogren's Syndrome at the time of screening.
3. ESSDAI ≥5 at screening (score calculated excluding renal, pulmonary and neurological domains)
4. Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at the Screening Visit.

Additional inclusion criteria are defined in the protocol

Exclusion Criteria:

1. 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)
2. 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).
3. Participants with severe fibromyalgia that could interfere with the assessment of response of Primary Sjogren's Disease to therapy
4. Active life-threatening or organ-threatening complications of Primary Sjogren's Disease at the time of screening based on investigator evaluation
5. Significant, uncontrolled medical disease in any organ system not related to Primary Sjogren's Disease (e.g., poorly controlled asthma, cardiovascular disease, accelerated hypertension, major depression, etc.) that in the opinion of the investigator would preclude participant participation.

Additional exclusion criteria are defined in the protocol

Trial Locations

• Chicago Clinical Research Institute Inc, Chicago, Illinois, United States
• Accurate Clinical Research, Inc., Lake Charles, Louisiana, United States
• Novel Research LLC, Bellaire, Texas, United States
• Accurate Clinical Research, Inc., Houston, Texas, United States
• Velocity Clinical Research, Waco, Waco, Texas, United States

Frequently Asked Questions

Related Conditions

• Primary Sjögren's Disease, Sjögren's Syndrome, Autoimmune Diseases, Rheumatology, Immunology

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