Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome

A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Subjects With Moderate to Severe Primary Sjögren's Syndrome

Sponsoren

Hauptsponsor: Bristol-Myers Squibb

Quelle Bristol-Myers Squibb
Kurze Zusammenfassung

The primary objective of this study is to evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's syndrome as measured by the change from baseline in ESSDAI at Week 12 between active treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm.

Gesamtstatus Terminated
Anfangsdatum October 18, 2016
Fertigstellungstermin July 24, 2017
Primäres Abschlussdatum July 24, 2017
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Mean Change From Baseline in ESSDAI At baseline and week 12
Sekundäres Ergebnis
Messen Zeitfenster
Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8 At baseline, week 4 and week 8
Mean Change From Baseline in ESSPRI Score at Week 4, Week 8, and Week 12. At baseline, week 4, week 8, and week 12
Proportion of Subjects With a > = 3 Point Improvement From Baseline in ESSDAI at Week 12 At week 12
Proportion of Subjects With Both >= 3 Points Improvement in ESSDAI and >= 1 Point Improvement in ESSPRI From Baseline at Week 12 At week 12
Proportions of Subjects With >=1 Point of Improvement From Baseline in ESSPRI At week 12
Mean Change in Baseline in ESSPRI Individual Component of Dryness At baseline, week 4, week 8, and week 12
Mean Change in Baseline in ESSPRI Individual Component of Fatigue At baseline, week 4, week 8, and week 12
Mean Change in Baseline in ESSPRI Individual Component of Pain At baseline, week 4, week 8, and week 12
Mean Change From Baseline in Unstimulated Salivary Flow Rate At baseline, week 4, week 8, and week 12
Mean Change From Baseline in Stimulated Salivary Flow Rate At baseline, week 4, week 8, and week 12
Mean Change From Baseline in Ocular Surface Staining At baseline, week 4, week 8, and week 12
Mean Change From Baseline in Schrimer's Test At baseline, week 4, week 8, and week 12
Mean Change From Baseline in the Tear Break-up Time Test At baseline, week 4, week 8, and week 12
Mean Change From Baseline in Numeric Rating Scale (NRS) for Mouth, Eye and Vaginal Dryness At baseline, at week 2, week 4, week 6, week 8, week 10, week 12, and week 18
Mean Change From Baseline in Subject Global Assessment of Disease Activity (SubGDA) At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
Mean Change Form Baseline in Physician Global Assessment of Disease Activity (phyGDA) At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
Mean Change From Baseline in Short Form-36 (SF-36) At baseline, week 4, week 8, week 12, and week 18
Mean Change From Baseline in Female Sexual Function Index (FSFI) At baseline, week 4, week 8, week 12, and week 18
Mean Change From Baseline in Work Participation and Activity Impairment Questionnaire (WPAI) At baseline, week 4, week 8, week 12, and week 18
Einschreibung 45
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: BMS-931699

Beschreibung: Specified dose on specified days

Armgruppenetikett: BMS-931699

Anderer Name: lulizumab

Interventionsart: Drug

Interventionsname: BMS-986142

Beschreibung: Specified dose on specified days

Armgruppenetikett: BMS-986142

Interventionsart: Drug

Interventionsname: Placebo

Beschreibung: Specified dose on specified days

Teilnahmeberechtigung

Kriterien:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

- Subjects diagnosed or classified as having moderate to severe primary Sjögren's Syndrome based on the 2016 ACR-EULAR Sjögren's Syndrome Classification Criteria for at least 16 weeks prior to screening

- ESSDAI ≥ 5 including disease activity (any score > 0) in at least one of the following domains: Glandular, Articular, Hematological, Biological, Lymphadenopathy

- Positive anti-SS-A/Ro and/or anti-SS-B/La autoantibody

- Unstimulated whole saliva secretion > 0.01 ml/min

- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug and must not be pregnant or breastfeeding. Male and female subjects must be willing to adhere to protocol-mandated highly effective contraception for the duration of the study and for the protocol-specified follow up period. Hormone-based contraceptive methods are not permitted

Exclusion Criteria:

- Secondary Sjögren's syndrome or the presence of any other systemic autoimmune disease (eg, RA, SLE, multiple sclerosis, vasculitis)

- Very severe primary Sjögren's syndrome or severe complications of primary Sjögren's syndrome at the time of the screening visit

- Active systemic or latent bacterial (including tuberculosis), viral or fungal infection, evidence of current or chronic Hepatitis B or C infection, or HIV infection

- Any significant concurrent medical condition at the time of screening or baseline visit

- Use of methotrexate, cyclophosphamide, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil (MMF) or leflunomide within 12 weeks of screening visit

- Previous treatment with biologics therapies either marketed or in development within 6 months prior to screening visit

- Treatment started or an unstable dose of hydroxychloroquine within 8 weeks of screening visit

- Oral corticosteroids > 10 mg/day within 14 days of dosing (Day 1), corticosteroid therapy ≥ 1 mg/kg during the 4 weeks preceding enrollment, or intravenous, intramuscular or intra-articular corticosteroids within 4 weeks of screening visit

Other protocol defined inclusion/exclusion criteria could apply

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 70 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Ort
Einrichtung:
St Joseph Heritage Healthcare | Fullerton, California, 92835, United States
Local Institution | Palo Alto, California, 94304, United States
Local Institution | Sarasota, Florida, 34239, United States
North Georgia Rheumatology Group | Lawrenceville, Georgia, 30096, United States
Clinical Pharmacology Study Group | Worcester, Massachusetts, 01605, United States
Local Institution | Tupelo, Mississippi, 38801, United States
Arthritis And Osteoporosis Associates, Pa | Freehold, New Jersey, 07728, United States
New Mexico Clinical Research & Osteoporosis Center | Albuquerque, New Mexico, 87109, United States
Local Institution | Mineola, New York, 11501, United States
Pmg Research Of Wilmington Llc | Wilmington, North Carolina, 28401, United States
Paramount Medical Research & Consulting, Llc | Middleburg Heights, Ohio, 44130, United States
Altoona Center For Clinical Research | Duncansville, Pennsylvania, 16635-8406, United States
Local Institution | Philadelphia, Pennsylvania, 19104, United States
Local Institution | Wexford, Pennsylvania, 15090, United States
Acme Research, Llc | Orangeburg, South Carolina, 29118, United States
West Tennessee Research Institute | Jackson, Tennessee, 38305, United States
Tekton Research Inc | Austin, Texas, 78745, United States
Local Institution | Camperdown, New South Wales, 2050, Australia
Local Institution | Santiago De Chile, Metropolitana, 7501126, Chile
Local Institution | Bogota, Cundinamarca, Colombia
Local Institution | Bogota, Colombia
Local Institution | Cali, Colombia
Azienda Ospedaliera Universitaria Pisana | Pisa, 56126, Italy
Local Institution | Mexico City, Distrito Fededral, 11850, Mexico
Local Institution | Guadalajara, Jalisco, 44650, Mexico
Local Institution | Merida, Yucatan, 97070, Mexico
Local Institution | Veracruz, 91910, Mexico
Local Institution | Cercado De Lima, Lima, 1, Peru
Local Institution | Lima, LIMA 31, Peru
Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac | Lima, LIMA 33, Peru
Klinika Reumatologii i Chorob Wewnetrznych | Wroclaw, 50-556, Poland
Local Institution | San Juan, 00909, Puerto Rico
Local Institution | Moscow, 121374, Russian Federation
Local Institution | Stellenbosch, Western CAPE, 7600, South Africa
Standort Länder

Australia

Chile

Colombia

Italy

Mexico

Peru

Poland

Puerto Rico

Russian Federation

South Africa

United States

Überprüfungsdatum

October 2018

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 3
Armgruppe

Etikette: BMS-931699

Art: Experimental

Beschreibung: Subcutaneous weekly injection + daily oral placebo tablets

Etikette: BMS-986142

Art: Experimental

Beschreibung: Daily oral tablets + subcutaneous placebo (weekly) injection

Etikette: Placebo

Art: Placebo Comparator

Beschreibung: Weekly subcutaneous placebo injection +daily oral placebo tablets

Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Double (Participant, Investigator)

Quelle: ClinicalTrials.gov