At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 75 enrolled

Drug / intervention

Placebo +1 moredrug

Likely dose

RO5459072 100 milligramsfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02701985

NCT02701985Phase 2Completed

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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2A Study to Assess the Efficacy of RO5459072 in Patients With Primary Sjogren's Syndrome

Hoffmann-La Roche·interventional·Posted Mar 8, 2016·Updated Aug 1, 2018

In Brief

A Phase 2 clinical trial evaluating Placebo and RO5459072 for Sjogren's Syndrome. Completed, enrolled 75 participants across 31 sites in 6 countries.

Detailed 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSjogren's Syndrome

CountriesFrance, Germany, Poland, Portugal, United Kingdom, United States

Collaborators--

Timeline

Phase 2CompletedFinished

20162017201820192020202120222023202420252026

First PostedMar 2016

Enrollment StartJul 2016

Primary CompletionJul 2017

TodayJul 2026

First PostedMar 8, 2016

Enrollment StartJul 5, 2016

Primary CompletionJul 10, 2017

TodayJul 2, 2026

Enrollment to primary: 1.0 yearsPosted 10.3 years ago

Interventions

Placebodrug

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

RO5459072drug

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