An Efficacy and Safety Study of Injectable Ravagalimab to Assess Change in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) in Adult Participants With Moderately to Severely Active Primary Sjogren's Syndrome (pSS)

NCT ID: NCT05217472

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-06
• Study Completion Date: 2022-05-15

Brief Summary

Sjogren's syndrome (SS) is a chronic, multisystem autoimmune disease characterized by lacrimal and salivary gland inflammation, with resultant dryness of the eyes and mouth and occasional glandular enlargement. In addition, a variety of systemic manifestations may occur; including fatigue, musculoskeletal symptoms, rashes, and internal organ (e.g., pulmonary, renal, hepatic, and neurologic) disease. Sjogren's syndrome may occur in isolation, primary Sjogren's syndrome (pSS), or in a secondary form, often associated with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), or systemic sclerosis. Ravagalimab is an investigational drug being developed to help treat patients with inflammatory diseases like SS. This study will evaluate how well ravagalimab works within the body and how safe it is in patients with primary SS (pSS).

Ravagalimab, a potent CD40 antagonist is an investigational drug being developed for the treatment of Sjogren's syndrome (SS). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Participants 18-75 years of age with Sjogren's syndrome (SS) will be enrolled. Around 45 participants will be enrolled in the study in multiple sites within Netherlands.

Participants will receive ravagalimab intravenous (IV) loading dose or IV placebo at baseline followed by subcutaneous (SC) ravagalimab or matching placebo for 22 weeks.

There will be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, labial gland (lip) biopsy, and checking for side effects and completing questionnaires.

Conditions

Sjogren's Syndrome (SS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ravagalimab

Participants will receive a loading dose of intravenous (IV) ravagalimab dose A at Week 0 followed by subcutaneous (SC) ravagalimab dose A every other week (eow)

Group Type: EXPERIMENTAL

Ravaglimab

Intervention Type: DRUG

Intravenous Injection

Ravagalimab

Intervention Type: DRUG

Subcutaneous Injection

Placebo

Participants will receive a loading dose of intravenous (IV) placebo at Week 0 followed by subcutaneous (SC) placebo every other week (eow)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous Injection

Placebo

Intervention Type: DRUG

Subcutaneous Injection

Interventions

Ravaglimab

Intravenous Injection

Intervention Type: DRUG

Ravagalimab

Subcutaneous Injection

Intervention Type: DRUG

Placebo

Intravenous Injection

Intervention Type: DRUG

Placebo

Subcutaneous Injection

Intervention Type: DRUG

Other Intervention Names

ABBV-323; ABBV-323

Eligibility Criteria

Inclusion Criteria

• Primary Sjogren's syndrome (pSS) diagnosed according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2016 Criteria.
• Lymphocyte focus score (local lymphocytic infiltrates) >= 1 in sublabial salivary gland specimen. Subjects with sublabial salivary gland biopsy obtained 3 months prior to Screening and meeting this criterion will be eligible without a biopsy at Screening. Subjects without a sublabial salivary gland biopsy within 3 months of Screening will obtain a biopsy for a lymphocyte focus score at Screening.
• EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) >= 5 at Screening.
• EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) >= 6 at Screening.

Exclusion Criteria

• History of clinically significant drug or alcohol abuse within the last 6 months.
• History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients), the ingredients of Chinese hamster ovary cells and/or other products in the same class.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

Universitair Medisch Centrum Utrecht /ID# 214029

Utrecht, , Netherlands

Countries

Netherlands

Other Identifiers

2019-003131-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M21-263

Identifier Type: -

Identifier Source: org_study_id