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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02701985
• Date of registration: 03/03/2016
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome
• Scientific title: 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
• Date of first enrolment: July 5, 2016
• Target sample size: 75
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02701985
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

France, Germany, Poland, Portugal, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- A diagnosis of primary Sjogren's syndrome according to the revised American-European
Consensus Group (AECG) criteria

- ESSDAI score greater than or equal to (>/=) 5

- ESSPRI score >/=5

- Elevated serum titers of anti-Sjogren's-syndrome-related antigen A (anti-SSA) and/or
anti-Sjogren's-syndrome-related antigen B (anti-SSB) antibodies at screening

- Negative pregnancy test at screening and baseline (for women only)

- Willing to comply with the study procedures and restrictions, including measures to
prevent pregnancy and restrictions on sperm donation

Exclusion Criteria:

- A diagnosis of secondary Sjogren's syndrome according to the revised AECG criteria

- Severe complications of Sjogren's syndrome

- Systemic immunosuppressant therapy, cyclophosphamide, or B-cell depleting therapy
within 6 months prior to the screening visit

- Corticosteroid therapy exceeding 7.5 mg prednisone equivalents per day

- A positive test result for hepatitis B (HBV), hepatitis C (HCV), or human
immunodeficiency virus (HIV), or tuberculosis, or any other active viral, fungal,
yeast or bacterial infection at screening

- A history suggesting reduced immune function or any other conditions predisposing
participants to serious infection

- A history of lymphoma, myeloma or monoclonal gammopathy of unknown significance
(MGUS), or any other malignancies within the past 5 years

- A diagnosis of fibromyalgia or significant depression

- Having any concomitant disease or condition that could interfere with the conduct of
the study, or that would pose an unacceptable risk to the individual

- Participation in an investigational drug or device study within 3 months prior to
screening

- Inability to comply with the study protocol for any other reason

- Women who are lactating, breastfeeding or planning to nurse

- Using other prohibited medication (moderate or potent inhibitors of CYP3A4; strong
inducers of CYP3A4; strong inhibitors of the transporter P-glycoprotein [P-gp];
sensitive substrates of CYP3A4 with a narrow therapeutic index)



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sjogren's Syndrome

Intervention(s)

Drug: RO5459072

Drug: Placebo

Primary Outcome(s)

Percentage of Participants With a Clinically Relevant Decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score [Time Frame: 12 weeks]

Secondary Outcome(s)

Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Score at Week 12 [Time Frame: Baseline (Week -1), Week 12]

Change From Baseline in SF-36 Physical Score at Week 12 [Time Frame: Baseline (Week -1), Week 12]

Change From Baseline in Tear Flow Rate at Weeks 2, 6, and 12 [Time Frame: Baseline, Week 2, Week 6, and Week 12]

Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen A at Weeks 6, and 12 [Time Frame: Baseline, Week 6, and Week 12]

Change From Baseline in Total Immunoglobulin G (IgG) at Weeks 6, and 12 [Time Frame: Baseline, Week 6, and Week 12]

Change From Baseline in ESSPRI Dryness Component Score at Week 12 [Time Frame: Baseline (Week -1), Week 12]

Change From Baseline in Mechanically Stimulated Salivary Flow Rate at Weeks 2, 6, and 12 [Time Frame: Baseline, Week 2, Week 6, and Week 12]

Change From Baseline in ESSPRI Score at Week 12 [Time Frame: Baseline (Week -1), Week 12]

Change From Baseline in ESSDAI Score at Week 12 [Time Frame: Baseline (Week -1), Week 12]

Change From Baseline in ESSPRI Fatigue Component Score at Week 12 [Time Frame: Baseline (Week -1), Week 12]

Change From Baseline in Total Immunoglobulin M (IgM) at Weeks 6, and 12 [Time Frame: Baseline, Week 6, and Week 12]

Maximum Concentration (Cmax) of RO5459072 [Time Frame: Week 2, Week 6, and Week 12]

Change From Baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Pain Component Score at Week 12 [Time Frame: Baseline (Week -1), Week 12]

Percentage of Participants With Adverse Events [Time Frame: Baseline up to Week 14]

Average Concentration (Caverage) of RO5459072 [Time Frame: Week 2, Week 6, and Week 12]

Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen B at Weeks 6, and 12 [Time Frame: Baseline, Week 6, and Week 12]

Change From Baseline in Rheumatoid Factor at Weeks 6, and 12 [Time Frame: Baseline, Week 6, and Week 12]

Minimum Concentration (Cmin) of RO5459072 [Time Frame: Week 2, Week 6, and Week 12]

Percentage of Participants With a Clinically Relevant Decrease in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score [Time Frame: 12 weeks]

Secondary ID(s)

BP30037

2015-004476-30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02701985