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Trial record 1 of 2 for:    igpro10_2001
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Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)

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ClinicalTrials.gov Identifier: NCT04138485
Recruitment Status : Active, not recruiting
First Posted : October 24, 2019
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
CSL Behring

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.


Condition or disease Intervention/treatment Phase
Diffuse Cutaneous Systemic Sclerosis Biological: IgPro10 Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 20, 2019
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023


Arm Intervention/treatment
Experimental: IgPro10
10% liquid formulation of human immunoglobulin for intravenous use
Biological: IgPro10
10% liquid formulation of human immunoglobulin for IVIG
Other Name: Human normal immunoglobulin

Placebo Comparator: Placebo
0.5% human albumin solution stabilized with 250 mmol/L L-proline
Biological: Placebo
0.5% human albumin solution stabilized with 250 mmol/L L-proline
Other Name: Albumin




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Proportion of subjects meeting cardiopulmonary or renal failure criteria in ACR CRISS Step 1 events [ Time Frame: Over 48 weeks ]
  2. Proportion of responders (ACR CRISS > 0.6) [ Time Frame: Over 48 weeks ]
  3. Mean change from Baseline in Modified Rodnan Skin Score (mRSS) [ Time Frame: Baseline and over48 weeks ]
  4. Mean change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Baseline and over 48 weeks ]
  5. Mean change from Baseline in Forced Vital Capacity (FVC)% predicted [ Time Frame: Baseline and over 48 weeks ]
  6. Mean change from Baseline in diffusing capacity of lung for carbon monoxide (DLCO)% predicted [ Time Frame: Baseline and over 48 weeks ]
  7. 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)

  8. 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)

  9. 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.

  10. Mean change from Baseline in Scleroderma Skin Patient Reported Outcome (SSPRO) score in IgPro10 vs Placebo [ Time Frame: Baseline and up to 48 weeks ]
  11. 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

  12. 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

  13. 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

  14. Mean change from Baseline in Cochin Hand Function Scale in IgPro10 vs Placebo [ Time Frame: Baseline and over 48 weeks ]
  15. Mean change from Baseline in Scleroderma Health Assessment Questionnaire (SHAQ) score in IgPro10 vs Placebo [ Time Frame: Baseline and over 48 weeks ]
  16. 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 ]
  17. 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 ]
  18. Percentage of subjects with AEs, TEAEs, SAEs, AESIs [ Time Frame: Over 48 weeks ]
  19. Concentration of serum trough IgG levels at Baseline and prior to first infusion [ Time Frame: Baseline and up to 72 weeks ]
  20. Mean change from Baseline in Modified Rodnan skin score (mRSS) [ Time Frame: Baseline and over 72 weeks ]
  21. Mean change from Baseline in Patient global assessment (PGA) [ Time Frame: Baseline and over 72 weeks ]
  22. Proportion of responders (ACR CRISS > 0.6) [ Time Frame: Over 72 weeks ]
  23. Mean change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Baseline and over 72 weeks ]
  24. Mean change from Baseline in Forced Vital Capacity (FVC)% predicted [ Time Frame: Baseline and over 72 weeks ]
  25. Mean change from Baseline in diffusing capacity of lung for carbon monoxide (DLCO)% predicted [ Time Frame: Baseline and over 72 weeks ]
  26. Mean change from Baseline in Physician Global Assessment (MDGA) [ Time Frame: Baseline and over 72 weeks ]
  27. 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 ]
  28. Percentage of subjects with AEs, TEAEs, SAEs, AESIs [ Time Frame: Over 72 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04138485


Locations
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Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Study Director CSL Behring

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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT04138485    
Other Study ID Numbers: IgPro10_2001
2019-000906-31 ( EudraCT Number )
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
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
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.


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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
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs