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A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome

NCT02701985 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2018-08-01

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group study designed to evaluate the effects of RO5459072 treatment on disease activity and symptoms of Sjogren's syndrome in adult participants with moderate to severe primary Sjogren's syndrome. The total duration of the study for each participant will be approximately 18 weeks (including screening).

Conditions

  • Sjogren's Syndrome

Interventions

DRUG

Placebo

Matching-placebo capsules will be administered orally, 2 times a day with food.

DRUG

RO5459072

RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day with food.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-05
Primary Completion
2017-07-10
Completion
2017-07-10

Countries

  • United States
  • France
  • Germany
  • Poland
  • Portugal
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02701985 on ClinicalTrials.gov