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

NCT02701985 | Completed Phase 2 Results

• 2 other identifiers: BP300372015-004476-30
• Study Type: interventional
• Target: 75
• Locations: 6 countries
• Sites: 31

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Clinically Relevant Decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score

  Percentage of participants with a clinically relevant decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score is defined as participants with absolute decrease of ≥ 3-points in ESSDAI score. ESSDAI is physician-assessed disease activity index developed by EULAR consortium consisting of 44 items in 12 organ-specific 'domains' (constitutional,lymphadenopathy, articular,muscular,cutaneous,glandular,pulmonary,renal,peripheral nervous system,central nervous system,hematological,biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A score ≥ 5 is considered moderate or severe disease activity and a clinically relevant change in ESSDAI score is defined as absolute decrease of ≥ 3-points.

  12 weeks

Secondary Outcomes (19)

• Percentage of Participants With a Clinically Relevant Decrease in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score

  12 weeks

• Change From Baseline in ESSDAI Score at Week 12

  Baseline (Week -1), Week 12

• Change From Baseline in ESSPRI Score at Week 12

  Baseline (Week -1), Week 12

• Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Score at Week 12

  Baseline (Week -1), Week 12

• Change From Baseline in SF-36 Physical Score at Week 12

  Baseline (Week -1), Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matching-placebo capsules will be administered orally, 2 times a day, for up to 12 weeks.

Drug: Placebo

RO5459072

EXPERIMENTAL

RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day, for up to 12 weeks.

Drug: RO5459072

Interventions

Placebo DRUG

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

Placebo

RO5459072 DRUG

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

RO5459072

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (31)

Wallace Rheumatic Study Center

Beverly Hills, California, 90211, United States

Location

Denver Arthritis Clinic

Denver, Colorado, 80230-7127, United States

Location

Ochsner Clinic Foundation

Baton Rouge, Louisiana, 70809, United States

Location

John Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

University Of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Shanahan Rheumatology & Immunology, PLLC

Raleigh, North Carolina, 27617, United States

Location

MetroHealth System

Cleveland, Ohio, 44109, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Clinical Research Center of Reading

Wyomissing, Pennsylvania, 19610, United States

Location

Ramesh Gupta - PP

Memphis, Tennessee, 38119, United States

Location

Hopital Avicenne, Paris

Bobigny, 93009, France

Location

C.H.U. Ambroise Pare (AP-HP)

Boulogne-Billancourt, 92104, France

Location

Hopital La Cavale Blanche; Rhumatologie

Brest, 29609, France

Location

Hopital Lapeyronie; Immunologie Rhumatologie

Montpellier, 34295, France

Location

Charité Research Organisation GmbH

Berlin, 10117, Germany

Location

Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob

Bydgoszcz, 85-168, Poland

Location

MedPolonia

Poznan, 60-693, Poland

Location

Niepubliczny Opieki Zdrowotnej; Reumatika - Ctr Reum.

Warsaw, 02-691, Poland

Location

Centrum Medyczne AMED

Warsaw, 03-291, Poland

Location

Instituto Portugues de Reumatologia

Lisbon, 1050-34, Portugal

Location

Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria

Lisbon, 1649-035, Portugal

Location

Centro Hospitalar do Porto - Hospital de Santo António

Porto, 4099-001, Portugal

Location

Centro Hospitalar de Sao Joao,E.P.E.

Porto, 4200-319, Portugal

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

Location

Barts and the London NHS Trust

London, E1 2ES, United Kingdom

Location

University College London Hospitals NHS Foundation Trust - University College Hospital

London, NW1 2PG, United Kingdom

Location

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust; Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

Great Western Hospitals NHS Foundation Trust.

Wiltshire, SN3 6BB, United Kingdom

Location

Related Publications (1)

• Bentley D, Fisher BA, Barone F, Kolb FA, Attley G. A randomized, double-blind, placebo-controlled, parallel group study on the effects of a cathepsin S inhibitor in primary Sjogren's syndrome. Rheumatology (Oxford). 2023 Nov 2;62(11):3644-3653. doi: 10.1093/rheumatology/kead092.

  PMID: 36864622 DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

petesicatib

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 8, 2016
• Study Start: July 5, 2016
• Primary Completion: July 10, 2017
• Study Completion: July 10, 2017
• Last Updated: August 1, 2018
• Results First Posted: August 1, 2018

Record last verified: 2018-07

Locations

DE (1); US (12); PL (4); FR (4); PT (4); GB (6)