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)

NCT05217472 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: M21-2632019-003131-31
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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)

Keywords

Sjogren's Syndrome (SS); Primary Sjogren's Syndrome (pSS); Ravagalimab; ABBV-323

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)

  ESSDAI is a systemic disease activity index including 12 domains (i.e., organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system, central nervous system, haematological, glandular, constitutional, lymphadenopathic and biological).

  Week 24

Secondary Outcomes (24)

• Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)

  Up to Week 16

• Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)

  Up to Week 24

• Change From Baseline in Tender Joint Count

  Up to Week 24

• Change From Baseline in Swollen Joint Count

  Up to Week 24

• Change From Baseline in Salivary Flow (Unstimulated)

  Up to Week 24

Study Arms (2)

Ravagalimab

EXPERIMENTAL

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)

Drug: Ravaglimab; Drug: Ravagalimab

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ravaglimab DRUG

Intravenous Injection

Also known as: ABBV-323

Ravagalimab

Ravagalimab DRUG

Subcutaneous Injection

Also known as: ABBV-323

Ravagalimab

Placebo DRUG

Intravenous Injection

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Universitair Medisch Centrum Utrecht /ID# 214029

Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 1, 2022
• Study Start: March 6, 2020
• Primary Completion: April 15, 2022
• Study Completion: May 15, 2022
• Last Updated: February 1, 2022

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

Locations

NL (1)