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Monoclonal Antibodies

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

Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2, week 6, and week 12

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).

Eligible Conditions
  • Sjogren's Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2, week 6, and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, week 6, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With a Clinically Relevant Decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score
Secondary study objectives
Average Concentration (Caverage) of RO5459072
Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen A at Weeks 6, and 12
Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen B at Weeks 6, and 12
+16 more

Side effects data

From 2017 Phase 2 trial • 75 Patients • NCT02701985
16%
Viral Upper Respiratory Tract Infection
13%
Urticaria
13%
Rash
13%
Nausea
13%
Upper Respiratory Tract Infection
13%
Headache
8%
Abdominal Pain
8%
Arthralgia
5%
Influenza
5%
Pruritus
5%
Diarrhoea
5%
Fatigue
5%
Blood Thyroid Stimulating Hormone Decreased
5%
Eczema
3%
Bronchitis
3%
Iron Deficiency Anaemia
3%
Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
RO5459072

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RO5459072Experimental Treatment1 Intervention
RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day, for up to 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Matching-placebo capsules will be administered orally, 2 times a day, for up to 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Petesicatib
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,463 Previous Clinical Trials
1,103,052 Total Patients Enrolled
1 Trials studying Sjogren's Syndrome
30 Patients Enrolled for Sjogren's Syndrome
Clinical TrialsStudy DirectorHoffmann-La Roche
2,233 Previous Clinical Trials
902,162 Total Patients Enrolled
~8 spots leftby Jan 2026
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