A Study of INCB050465 in Primary Sjögren's Syndrome

NCT03627065 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: INCB 50465-207Parsaclisib
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of Sjögren's syndrome (SS).

Conditions

Primary Sjögren's Syndrome

Keywords

Primary Sjögren's syndrome; PI3Kδ inhibitor

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands

  The SGUS is a combination of the scores of the 4 salivary glands (2 parotid and 2 submandibular) each gland is scored on a 5-point scale (0 to 4; 4 being more severe), with the maximum total score being 16.

  Week 4 and Week 12

Secondary Outcomes (17)

• Change From Baseline in Salivary CXCL13 Levels

  Baseline, Week 4 and Week 12

• Number of Participants With Treatment-emergent Adverse Events

  Up to 21 weeks

• Change in Whole Salivary Flow

  Baseline, Weeks 4, 8, and 12

• Change in EULAR Sjögren's Syndrome Disease Activity Index

  Week 12

• Change in EULAR Sjögren's Syndrome Patient Reported Index

  Weeks 4, 8, and 12

Study Arms (1)

Parsaclisib

EXPERIMENTAL

Drug: Parsaclisib

Interventions

Parsaclisib DRUG

Parsaclisib administered orally once daily at the protocol-defined dose.

Also known as: INCB050465

Parsaclisib

Eligibility Criteria

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

You may qualify if:

• Primary SS diagnosed according to the revised American-European Consensus Group (AECG) criteria.
• Minimum score of 2 on the SGUS score for parotid and submandibular glands.
• EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥ 5.
• Positive serum titers of anti-SS-A and/or anti-SS-B antibodies.
• Symptomatic oral dryness score of at least 5 on patient questionnaire.
• Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

You may not qualify if:

• Diagnosis of secondary SS according to the revised AECG criteria (eg, the presence of a previously diagnosed or a present diagnosis of rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis, dermatomyositis, immunoglobulin G4-related disorder, sarcoidosis, or any other defined autoimmune rheumatologic disorder).
• Concurrent conditions and history of other diseases per protocol-defined criteria.
• Positive test results for tuberculosis (TB) from the QuantiFERON-TB Gold test or T-spot.TB test.
• Positive serology test results for HIV antibody, hepatitis B surface antigen, hepatitis B surface antigen antibody, HBV core antibody, or HCV (HCV antibody with positive HCV-RNA).
• Severely impaired liver function (Child-Pugh Class C).
• Prior or ongoing therapy with protocol-defined drugs.
• Receipt of any live vaccine in the 30 days before screening.
• No major surgery within 30 days before screening. Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
• Current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the dose regimen and study evaluations.
• Laboratory values at screening outside the protocol-defined ranges.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (4)

Advanced Pharma CR

Miami, Florida, 33147, United States

Location

North Georgia Rheumatology Group

Lawrenceville, Georgia, 30046, United States

Location

The Center for Rheumatology and Bone Research

Wheaton, Maryland, 20902, United States

Location

Ramesh C. Gupta, MD

Memphis, Tennessee, 38119-5208, United States

Location

MeSH Terms

Interventions

parsaclisib

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Kathleen Butler, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 13, 2018
• Study Start: February 28, 2019
• Primary Completion: December 7, 2019
• Study Completion: January 2, 2020
• Last Updated: August 13, 2021
• Results First Posted: March 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)