A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome

Conditions

• Sjögren Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Remibrutinib — DRUG
  Remibrutinib 100 mg was administered orally as two 50 mg hard gelatin capsules. Patients in the remibrutinib 100 mg bid dose group took 2 capsules of active medication in the morning and 2 capsules of active medication in the evening. Patients in the remibrutinib 100 mg qd dose group took 2 capsules of active medication in the morning and 2 capsules of the placebo in the evening.
• Placebo — DRUG
  Placebo was administered orally as two hard gelatin capsules. Patients in the placebo dose group took 2 capsules of placebo in the morning and 2 capsules of placebo in the evening.

Study Details

This was an adaptive design phase 2 study to establish safety and efficacy; and to characterize the dose-response of LOU064 in subjects with moderate to severe Sjögren's syndrome. LOU064 is an oral Bruton's tyrosine kinase (BTK) inhibitor.

Key Dates

Start date

Jul 12, 2019

Status verified

Jan 2023

Primary completion

Nov 23, 2021

Completion

Nov 23, 2021

Study Design

Enrollment

73 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Remibrutinib 100 mg bid
  Remibrutinib 100 mg twice daily (bid)
• Experimental: Remibrutinib 100 mg qd
  Remibrutinib 100 mg once daily (qd)
• Placebo Comparator: Placebo
  Placebo group

Primary Outcome Measure

Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Total Score at Week 24 [ Time Frame: Baseline, Week 24 ]

Locations (1)

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