Phase 2
N=75
A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome
Sjogren's Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02701985 ↗Enrolled (actual)
75
Serious AEs
4.0%
Results posted
Aug 2018
Primary outcome: Primary: Percentage of Participants With a Clinically Relevant Decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score — 37.8; 42.1 Percentage of Participants — p=0.7955
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); RO5459072 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Clinically Relevant Decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score |
37.8; 42.1 | 0.7955 |
| SECONDARY Percentage of Participants With a Clinically Relevant Decrease in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score |
56.8; 57.9 | 0.9877 |
| SECONDARY Change From Baseline in ESSDAI Score at Week 12 |
11.27; 11.79; -3.06; -3.25 | 0.8905 |
| SECONDARY Change From Baseline in ESSPRI Score at Week 12 |
7.34; 6.98; -1.35; -1.51 | 0.6077 |
| SECONDARY Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Score at Week 12 |
42.09; 40.52; 4.52; 3.02 | 0.2846 |
| SECONDARY Change From Baseline in SF-36 Physical Score at Week 12 |
40.86; 40.71; 2.46; 3.01 | 0.8134 |
| SECONDARY Change From Baseline in ESSPRI Dryness Component Score at Week 12 |
7.54; 7.45; -1.15; -1.77 | — |
| SECONDARY Change From Baseline in ESSPRI Fatigue Component Score at Week 12 |
7.22; 7.24; -1.29; -1.94 | — |
| SECONDARY Change From Baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Pain Component Score at Week 12 |
7.27; 6.26; -1.62; -0.97 | — |
| SECONDARY Change From Baseline in Tear Flow Rate at Weeks 2, 6, and 12 |
7.53; 7.84; -0.54; -0.81; -1.39; -0.95 | 0.4266 |
| SECONDARY Change From Baseline in Mechanically Stimulated Salivary Flow Rate at Weeks 2, 6, and 12 |
0.45; 0.55; 0.10; -0.01; 0.10; 0.11 | 0.6429 |
| SECONDARY Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen A at Weeks 6, and 12 |
214.52; 217.78; -4.82; -1.47; -2.57; -5.20 | — |
| SECONDARY Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen B at Weeks 6, and 12 |
101.66; 76.94; 1.94; -2.55; 1.35; -4.47 | — |
| SECONDARY Change From Baseline in Rheumatoid Factor at Weeks 6, and 12 |
43.00; 117.84; -1.50; -28.03; -0.68; -57.77 | — |
| SECONDARY Change From Baseline in Total Immunoglobulin G (IgG) at Weeks 6, and 12 |
15.74; 13.59; 0.11; -0.30; 0.48; -0.50 | — |
| SECONDARY Change From Baseline in Total Immunoglobulin M (IgM) at Weeks 6, and 12 |
1.24; 1.26; 0.03; -0.10; 0.06; -0.17 | — |
| SECONDARY Minimum Concentration (Cmin) of RO5459072 |
1340 | — |
| SECONDARY Maximum Concentration (Cmax) of RO5459072 |
2350 | — |
| SECONDARY Average Concentration (Caverage) of RO5459072 |
1740 | — |
| SECONDARY Percentage of Participants With Adverse Events |
78.4; 76.3 | — |
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).
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT02701985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.