Nipocalimab in Moderate to Severe Sjogren's Disease (DAFFODIL)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 3

Conditions: Sjogrens Syndrome

Treatments: Drug: Placebo; Drug: Standard of care treatment; Drug: Nipocalimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06741969

80202135SJS3001 (Other Identifier)

2024-513965-38-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).

Full description

This clinical development program for nipocalimab in SjD includes 2 identical double blind, placebo-controlled studies to evaluate the efficacy, safety, and tolerability of nipocalimab in participants greater than or equal to (>=) 18 years of age with moderate to severe SjD.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
• Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria
• Seropositive for antibodies to Ro/SSA (Ro60 and/or Ro52) at screening
• Total ClinESSDAI score greater than or equal to (>=) 5 at screening
• Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization

Exclusion criteria

• Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory
• Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation
• Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency
• Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example [e.g.], monoclonal antibodies, intravenous immunoglobulin)
• Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

600 participants in 2 patient groups, including a placebo group

Nipocalimab

Experimental group

Description:

Participants will receive nipocalimab subcutaneously (SC) along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) phase, where they will continue to receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.

Treatment:

Drug: Nipocalimab

Drug: Standard of care treatment

Placebo

Placebo Comparator group

Description:

Participants will receive placebo subcutaneously along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an OLE phase, where they will receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.

Treatment:

Drug: Standard of care treatment

Drug: Placebo