A Study of INCB050465 in Primary Sjögren's Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 24 August 2021
• Main ID: NCT03627065
• Date of registration: 08/08/2018
• Prospective Registration: Yes
• Primary sponsor: Incyte Corporation
• Public title: A Study of INCB050465 in Primary Sjögren's Syndrome
• Scientific title: An Open-Label Phase 2 Study of INCB050465 in Participants With Primary Sjögren's Syndrome
• Date of first enrolment: February 28, 2019
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03627065
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Kathleen Butler, MD
• Affiliation: Incyte Corporation

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sjögren's Syndrome

Intervention(s)

Drug: Parsaclisib

Primary Outcome(s)

Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands [Time Frame: Week 4 and Week 12]

Secondary Outcome(s)

Change in EULAR Sjögren's Syndrome Disease Activity Index [Time Frame: Week 12]

Patient Global Impression of Change Questionnaire [Time Frame: Baseline, Weeks 4, 8, and 12]

Change in EULAR Sjögren's Syndrome Patient Reported Index [Time Frame: Weeks 4, 8, and 12]

Female Participants Only : Change in Female Sexual Function Index [Time Frame: Weeks 4, 8, and 12]

Percentage Change in European Quality of Life 5 Dimensions Questionnaire [Time Frame: Weeks 4, 8, and 12]

Percentage Change in Symptom Scores for Dryness [Time Frame: Weeks 4, 8, and 12.]

Percentage Change in EULAR Sjögren's Syndrome Disease Activity Index [Time Frame: Week 12]

Number of Participants With Treatment-emergent Adverse Events [Time Frame: Up to 21 weeks]

Percentage Change in EULAR Sjögren's Syndrome Patient Reported Index [Time Frame: Weeks 4, 8, and 12]

Change in Symptom Scores for Dryness [Time Frame: Weeks 4, 8, and 12.]

Female Participants Only : Percentage Change in Female Sexual Function Index [Time Frame: Weeks 4, 8, and 12]

Change in European Quality of Life 5 Dimensions Questionnaire [Time Frame: Weeks 4, 8, and 12]

Percentage Change in PROMIS Fatigue Short Form [Time Frame: Weeks 4, 8, and 12]

Change in PROMIS Fatigue Short Form [Time Frame: Weeks 4, 8, and 12]

Change in Whole Salivary Flow [Time Frame: Baseline, Weeks 4, 8, and 12]

Change From Baseline in Salivary CXCL13 Levels [Time Frame: Baseline, Week 4 and Week 12]

Percentage Change in Whole Salivary Flow [Time Frame: Baseline, Weeks 4, 8, and 12]

Secondary ID(s)

Parsaclisib

INCB 50465-207

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/03/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03627065