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Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04138485
Recruitment Status : Recruiting
First Posted : October 24, 2019
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Tracking Information
First Submitted Date  ICMJE October 14, 2019
First Posted Date  ICMJE October 24, 2019
Last Update Posted Date March 23, 2020
Actual Study Start Date  ICMJE December 20, 2019
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2019)
Response on American College of Rheumatology Combined Response Index in Diffuse Systemic Sclerosis (ACR CRISS) score in IgPro10 vs Placebo [ Time Frame: Over 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2019)
  • Proportion of subjects meeting cardiopulmonary or renal failure criteria in ACR CRISS Step 1 events [ Time Frame: Over 48 weeks ]
  • Proportion of responders (ACR CRISS > 0.6) [ Time Frame: Over 48 weeks ]
  • Mean change from Baseline in Modified Rodnan Skin Score (mRSS) [ Time Frame: Baseline and over48 weeks ]
  • Mean change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Baseline and over 48 weeks ]
  • Mean change from Baseline in Forced Vital Capacity (FVC)% predicted [ Time Frame: Baseline and over 48 weeks ]
  • Mean change from Baseline in diffusing capacity of lung for carbon monoxide (DLCO)% predicted [ Time Frame: Baseline and over 48 weeks ]
  • Mean change from Baseline in Physician Global Assessment (MDGA) [ Time Frame: Baseline and over 48 weeks ]
    MDGA evaluates the overall impact of SSc on the participant as assessed by the physician on a 11-point Numeric rating scale scale from 0 (excellent) to 10 (extremely poor)
  • Mean change from Baseline in Patient Global Assessment (PGA) [ Time Frame: Baseline and over 48 weeks ]
    PGA evaluates the overall impact of SSc on the participant as assessed by the physician on a 11-point Numeric rating scale scale from 0 (excellent) to 10 (extremely poor)
  • Mean change from Baseline in UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract 2.0 (UCLA SCTC GIT 2.0) total score and subscale [ Time Frame: Baseline and over 48 weeks ]
    This survey consists of 34 questions and items are scored on a scale of 0 (better health) to 3 (worse health). Scores are combined to form total score.
  • Mean change from Baseline in Scleroderma Skin Patient Reported Outcome (SSPRO) score in IgPro10 vs Placebo [ Time Frame: Baseline and up to 48 weeks ]
  • Proportion of responders in mRSS [ Time Frame: Up to 48 weeks ]
    Response is decrease of mRSS ≥ 5 points and change of ≥ 25% from Baseline in IgPro10 vs Placebo
  • Time to treatment failure (time from first infusion to time of first event) in IgPro10 vs Placebo [ Time Frame: Over 48 weeks ]
    Treatment failure - defined as occurrence of SSc associated complications in ACR CRISS step 1 events, digital ischemia (requiring hospitalization for IV prostacyclin, surgical intervention or amputation), serious gastrointestinal events (events requiring parenteral nutrition due to SSc -such as total parenteral nutrition or enteral nutrition), all-cause mortality
  • Proportion of subjects with events at Week 48 in IgPro10 vs Placebo [ Time Frame: Over 48 weeks ]
    Events defined as occurrence of SSc associated complications in ACR CRISS step 1 events, digital ischemia (requiring hospitalization for IV prostacyclin, surgical intervention or amputation), serious gastrointestinal events (events requiring parenteral nutrition due to SSc -such as total parenteral nutrition or enteral nutrition), all -cause mortality
  • Mean change from Baseline in Cochin Hand Function Scale in IgPro10 vs Placebo [ Time Frame: Baseline and over 48 weeks ]
  • Mean change from Baseline in Scleroderma Health Assessment Questionnaire (SHAQ) score in IgPro10 vs Placebo [ Time Frame: Baseline and over 48 weeks ]
  • Mean change from baseline in muscle strength as measured by Manual Muscle Testing 8 (MMT) in IgPro10 vs Placebo [ Time Frame: Baseline and over 48 weeks ]
  • Number of subjects with adverse events (AEs) including any AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs) [ Time Frame: Over 48 weeks ]
  • Percentage of subjects with AEs, TEAEs, SAEs, AESIs [ Time Frame: Over 48 weeks ]
  • Concentration of serum trough IgG levels at Baseline and prior to first infusion [ Time Frame: Baseline and up to 72 weeks ]
  • Mean change from Baseline in Modified Rodnan skin score (mRSS) [ Time Frame: Baseline and over 72 weeks ]
  • Mean change from Baseline in Patient global assessment (PGA) [ Time Frame: Baseline and over 72 weeks ]
  • Proportion of responders (ACR CRISS > 0.6) [ Time Frame: Over 72 weeks ]
  • Mean change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Baseline and over 72 weeks ]
  • Mean change from Baseline in Forced Vital Capacity (FVC)% predicted [ Time Frame: Baseline and over 72 weeks ]
  • Mean change from Baseline in diffusing capacity of lung for carbon monoxide (DLCO)% predicted [ Time Frame: Baseline and over 72 weeks ]
  • Mean change from Baseline in Physician Global Assessment (MDGA) [ Time Frame: Baseline and over 72 weeks ]
  • Number of subjects with adverse events (AEs) including any AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs) [ Time Frame: Over 72 weeks ]
  • Percentage of subjects with AEs, TEAEs, SAEs, AESIs [ Time Frame: Over 72 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Cutaneous Systemic Sclerosis
Intervention  ICMJE
  • Biological: IgPro10
    10% liquid formulation of human immunoglobulin for IVIG
    Other Name: Human normal immunoglobulin
  • Biological: Placebo
    0.5% human albumin solution stabilized with 250 mmol/L L-proline
    Other Name: Albumin
Study Arms  ICMJE
  • Experimental: IgPro10
    10% liquid formulation of human immunoglobulin for intravenous use
    Intervention: Biological: IgPro10
  • Placebo Comparator: Placebo
    0.5% human albumin solution stabilized with 250 mmol/L L-proline
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 22, 2019)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Age ≥18 years (male or female) at time of providing written informed consent
  • Documented diagnosis of dcSSc 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.

Exclusion Criteria:

  • 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.
  • History of documented thrombotic episode eg, PE, DVT, myocardial infarction, thromboembolic stroke at any time Note: past superficial thrombophlebitis more than two years from Screening is not exclusionary
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Registration Coordinator 610-878-4000 clinicaltrials@cslbehring.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Canada,   France,   Germany,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04138485
Other Study ID Numbers  ICMJE IgPro10_2001
2019-000906-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (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.

Responsible Party CSL Behring
Study Sponsor  ICMJE CSL Behring
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director CSL Behring
PRS Account CSL Behring
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP