Study Stopped
Due to business reasons, not safety issues
Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)
A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults With Systemic Sclerosis
2 other identifiers
interventional
N/A
13 countries
77
Brief Summary
This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period. Eligible subjects will be randomized at Baseline in a 2:1 ratio of treatment IgPro10 or placebo in the DB Treatment Period. All subjects who enter OL Treatment Period will receive IgPro10.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2019
Shorter than P25 for phase_2
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2019
CompletedFirst Posted
Study publicly available on registry
October 24, 2019
CompletedStudy Start
First participant enrolled
December 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2020
CompletedNovember 17, 2020
November 1, 2020
9 months
October 14, 2019
November 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Response on American College of Rheumatology Combined Response Index in Diffuse Systemic Sclerosis (ACR CRISS) score in IgPro10 vs Placebo
Over 48 weeks
Secondary Outcomes (28)
Proportion of subjects meeting cardiopulmonary or renal failure criteria in ACR CRISS Step 1 events
Over 48 weeks
Proportion of responders (ACR CRISS > 0.6)
Over 48 weeks
Mean change from Baseline in Modified Rodnan Skin Score (mRSS)
Baseline and over48 weeks
Mean change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Baseline and over 48 weeks
Mean change from Baseline in Forced Vital Capacity (FVC)% predicted
Baseline and over 48 weeks
- +23 more secondary outcomes
Study Arms (2)
IgPro10
EXPERIMENTAL10% liquid formulation of human immunoglobulin for intravenous use
Placebo
PLACEBO COMPARATOR0.5% human albumin solution stabilized with 250 mmol/L L-proline
Interventions
Eligibility Criteria
You may qualify if:
- \. Age ≥18 years (male or female) at time of providing written informed consent
- Documented diagnosis of SSc according to ACR / EULAR criteria 2013
- mRSS ≥ 15 and ≤ 45
- Disease duration ≤ 5 years defined as the time from the first non-Raynaud's phenomenon manifestation
- Subjects within first 18 months of disease duration from first non-Raynaud's phenomenon manifestation.
You may not qualify if:
- Primary rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, and dermatomyositis, as determined by the investigator Note: Subjects with fibromyalgia, secondary Sjogren's syndrome, and scleroderma-associated myopathy or myositis at Screening are not excluded
- Positive anti-centromere autoantibodies at Screening
- Evidence of severe chronic kidney disease with estimated glomerular filtration rate \< 45 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation) or receiving dialysis. Additionally, subjects with current confirmed diagnosis of diabetes mellitus and requiring medication, with eGFR \< 90 mL/min/1.73m2 will be excluded from the study.
- Documented thrombophilic abnormalities including blood hyperviscosity, protein S or protein C deficiency, anti-thrombin-3 deficiency, plasminogen deficiency, antiphospholipid syndrome, Factor V Leiden mutation, dysfibrinogenemia, or prothrombin G20210A mutation
- Greater than 3 specified current risk factors for TEEs (documented and currents conditions): atrial fibrillation, coronary disease, diabetes mellitus, dyslipidemia, hypertension, obesity (Body Mass Index ≥ 30 kg/m2), recent significant trauma, and immobility (wheelchair-bound or bedridden)
- Ongoing active serious infection at Screening (including, but not limited to, pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess)
- Malignancy in the past 2 years, except for non-melanoma skin cancer, cervical carcinoma in situ, or other in situ cancer if it has been excised and treated within in the past year
- Known hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration \> 0.2 g/L)
- Known IgA deficiency or serum IgA level \< 5% lower limit of normal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (77)
Mayo Clinic Arizona - Scottsdale
Scottsdale, Arizona, 85259, United States
Pacific Arthritis Care Center
Los Angeles, California, 90045, United States
University of California
Los Angeles, California, 90095, United States
Stanford University Medical Center
Palo Alto, California, 94304, United States
University of Colorado
Aurora, Colorado, 80045, United States
Lombardi Cancer Center-Georgetown University
Washington D.C., District of Columbia, 20007, United States
Alliance for Multispecialty Research
Wichita, Kansas, 67207, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103, United States
John Hopkins Bayview Medical Center
Baltimore, Maryland, 21287, United States
Boston University Amyloidosis Center
Boston, Massachusetts, 02118, United States
University of Michigan Health System
Ann Arbor, Michigan, 48108, United States
Rutgers Clinical Research Center
New Brunswick, New Jersey, 08901, United States
Northwell Health
Great Neck, New York, 11021, United States
Hospital For Special Surgery
New York, New York, 10021, United States
Cleveland Clinic - Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Altoona Center For Research
Duncansville, Pennsylvania, 16635, United States
University of Pennsylvania - Perelman Center
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
The University Of Texas Medical School At Houston (Utms)
Houston, Texas, 77030, United States
APRILLUS Asistencia e Investigacion Clinica
Buenos Aires, C1194AAO, Argentina
Hospital Militar Central
Buenos Aires, C1426AAL, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, S2000SDV, Argentina
Sanatorio Parque S.A y Consultorios Externos Asociados
Rosario, C1181ACH, Argentina
John Hunter Hospital / Autoimmune Resource and Research Centre
New Lambton Heights, New South Wales, 2305, Australia
PARC Clinical Research
Adelaide, South Australia, 5005, Australia
UZ Gent
Ghent, 9000, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Mount Sinai Hospital, The Rebecca Macdonald Centre For Arthritis
Toronto, M5T 3L9, Canada
CHU de Caen
Caen, 14000, France
CHRU de Lille Hopital Huriez
Lille, 59037, France
Internal Medicine, Nantes University Hospital
Nantes, 44000, France
Assistance Publique - Hopitaux de Paris (AP-HP)
Paris, 75014, France
CHU de Rennes-Hopital Sud
Rennes, 35203, France
Centre Hospitalier Universitaire de Rouen-Hopital
Rouen, 76000, France
CHU Hautepierre
Strasbourg, 67098, France
Kerckhoff Klinik GmbH, Abteilung für Rheumatologie und Klinische Immunologie Rheumatologie
Bad Nauheim, 61231, Germany
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, 10117, Germany
Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, 10117, Germany
University Hospital of Cologne
Cologne, 50937, Germany
Universitaetsklinikum Freiburg- Klinik fuer Rheumatologie und Klinische Immunologie
Freiburg im Breisgau, 79106, Germany
Universitaetsmedizin der Johannes Gutenberg
Mainz, 55131, Germany
University Hospital Of Tuebingen
Tübingen, 72076, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Hospital St. Josef
Wuppertal, 42105, Germany
Universita degli Study di Ancona
Ancona, 60121, Italy
Universita Degli Studi Di Bari Aldo Moro
Bari, 70121, Italy
Universita degli Studi Di Brescia
Brescia, 25123, Italy
Universita degli Studi Firenze
Florence, 50139, Italy
UOC Immunoreumatologia
L’Aquila, 67100, Italy
Azienda Ospedaliera Gaetano Pini
Milan, 20122, Italy
Modena University
Modena, 41121, Italy
Universita degli Studi di Napoli Federico II
Napoli, 80138, Italy
IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
Rome, 00161, Italy
Centro Integral en Reumatologia, SA de CV
Guadalajara, 44160, Mexico
Centro De Estudios De Investigation Basica Y Clinica S.C
Jalisco, 44690, Mexico
Cliditer, S.A. DE C.V.
Mexico City, 06700, Mexico
Centro de Investigacion y Tratamiento Reumatologico S.C.
Mexico City, 11850, Mexico
Instituto Nacional De Ciencias Medicas Y Nutricion
México, 14080, Mexico
Centro de Alta Especialidad en Reumatologia
San Luis Potosí City, 78213, Mexico
Uniwersytecki Szpital Kliniczny W Bialymstoku
Bialystok, 15-369, Poland
University Clinical Centre, Medical University of Gdansk
Gdansk, 80-211, Poland
Samodzielny Publiczny Szpital Kliniczny
Katowice, 40-635, Poland
Klinika Dermatologii Szpital im. Dzieciątka Jezus
Warsaw, 00-001, Poland
Klinika i Poliklinika Układowych Chorób Tkanki Łącznej Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, 02-637, Poland
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006, Spain
Hospital Universitari Materno Infantil Vall Dhebron
Barcelona, 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28009, Spain
Hospital Univ 12 de Octubre
Madrid, 28041, Spain
Hospital Infanta Luisa Quirónsalud
Seville, 41010, Spain
Hospital Universitari Dr.Peset
Valencia, 46017, Spain
Cantonal Hospital St. Gallen - Klinik fuer Rheumatologie
Sankt Gallen, 9007, Switzerland
Countess of Chester Hospital
Chester, CH2 1UL, United Kingdom
Chapel Allerton Hospital
Leeds, LS7 4SA, United Kingdom
Royal Free Hospital-Royal Free London NHS Foundation Trust
London, NW3 2QG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
CSL Behring
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2019
First Posted
October 24, 2019
Study Start
December 20, 2019
Primary Completion
September 16, 2020
Study Completion
September 16, 2020
Last Updated
November 17, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
- Access Criteria
- Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee. An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee. The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
CSL will consider requests to share Individual Patient Data (IPD) from systemic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.