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Trial record 1 of 1 for:    IgPro20_2001
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Safety and Pharmacokinetics of IgPro20 and 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04137224
Recruitment Status : Completed
First Posted : October 23, 2019
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Tracking Information
First Submitted Date  ICMJE October 21, 2019
First Posted Date  ICMJE October 23, 2019
Last Update Posted Date August 3, 2022
Actual Study Start Date  ICMJE September 19, 2019
Actual Primary Completion Date May 17, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2019)
  • Number of subjects with adverse events (AEs) for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Percentage of subjects with AEs for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Number and percentage of subjects with treatment emergent adverse events (TEAEs) for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Number and percentage of subjects with seriouis adverse events (SAEs) for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Number and percentage of subjects with adverse events of special interest (AESIs) for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Number of patients with AEs categorized as infusion site reactions (ISRs) for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Percentage of patients with AEs categorized as ISRs for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Rate of ISRs per subject for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Rate of ISRs per infusion for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Onset of ISRs for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Duration of ISRs for IgPro20 [ Time Frame: Up to 16 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2019)
  • Number of subjects with adverse events (AEs) for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Percentage of subjects with AEs for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Number of patients with AEs categorized as infusion site reactions (ISRs) for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Percentage of patients with AEs categorized as ISRs for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Rate of ISRs per subject for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Rate of ISRs per infusion for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Onset of ISRs for IgPro20 [ Time Frame: Up to 16 weeks ]
  • Duration of ISRs for IgPro20 [ Time Frame: Up to 16 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2019)
  • IgPro20 relative bioavailability (%F) [ Time Frame: Up to 16 weeks ]
  • Area under the concentration curve to the end of the dosing period (AUC0-tau) for IgPro20 [ Time Frame: Up to 240 hours after first infusion ]
  • Area under the concentration curve up to the last measurable concentration (AUC0-last) for IgPro20 [ Time Frame: Up to 240 hours after first infusion ]
  • Maximum plasma drug concentration (Cmax) for IgPro20 [ Time Frame: Up to 240 hours after first infusion ]
  • Minimum plasma drug concentration (Ctrough) for IgPro20 [ Time Frame: Prior to infusion ]
  • Area under the concentration curve to the end of the dosing period (AUC0-tau) for IgPro10 [ Time Frame: Up to 672 hours after first infusion ]
  • Area under the concentration curve up to the last measurable concentration (AUC0-last) for IgPro10 [ Time Frame: Up to 672 hours after first infusion ]
  • Maximum plasma drug concentration (Cmax) for IgPro10 [ Time Frame: Up to 672 hours after first infusion ]
  • Minimum plasma drug concentration (Ctrough) for IgPro10 [ Time Frame: Prior to infusion ]
  • Number and percentage of subjects with AEs for IgPro10 [ Time Frame: Up to 16 weeks ]
  • Number and percentage of subjects with treatment emergent adverse events (TEAEs) for IgPro10 [ Time Frame: Up to 16 weeks ]
  • Number and percentage of subjects with seriouis adverse events (SAEs) for IgPro10 [ Time Frame: Up to 16 weeks ]
  • Number and percentage of subjects with adverse events of special interest (AESIs) for IgPro10 [ Time Frame: Up to 16 weeks ]
  • Number and percentage of subjects with AEs categorized as ISRs for IgPro10 [ Time Frame: Up to 16 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2019)
  • IgPro20 relative bioavailability (%F) [ Time Frame: Up to 16 weeks ]
  • Area under the concentration curve to the end of the dosing period (AUC0-tau) for IgPro20 [ Time Frame: Up to 240 hours after first infusion ]
  • Area under the concentration curve up to the last measurable concentration (AUC0-last) for IgPro20 [ Time Frame: Up to 240 hours after first infusion ]
  • Maximum plasma drug concentration (Cmax) for IgPro20 [ Time Frame: Up to 240 hours after first infusion ]
  • Minimum plasma drug concentration (Ctrough) for IgPro20 [ Time Frame: Prior to infusion ]
  • Area under the concentration curve to the end of the dosing period (AUC0-tau) for IgPro10 [ Time Frame: Up to 672 hours after first infusion ]
  • Area under the concentration curve up to the last measurable concentration (AUC0-last) for IgPro10 [ Time Frame: Up to 672 hours after first infusion ]
  • Maximum plasma drug concentration (Cmax) for IgPro10 [ Time Frame: Up to 672 hours after first infusion ]
  • Minimum plasma drug concentration (Ctrough) for IgPro10 [ Time Frame: Prior to infusion ]
  • Number and percentage of subjects with AEs for IgPro10 [ Time Frame: Up to 16 weeks ]
  • Number and percentage of subjects with AEs categorized as ISRs for IgPro10 [ Time Frame: Up to 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
Official Title  ICMJE A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) and IgPro10 (Intravenous Immunoglobulin, Privigen®) in Adults With Systemic Sclerosis (SSc)
Brief Summary This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in subjects with diffuse cutaneous systemic sclerosis (dcSSc). The pharmacokinetic study aims to evaluate the relative bioavailability of IgPro20, and characterize pharmacokinetics of IgPro20 and IgPro10, respectively, in subjects with dcSSc. Safety, tolerability, and pharmacokinetics of IgPro10 will also be evaluated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Cutaneous Systemic Sclerosis
Intervention  ICMJE
  • Biological: IgPro20
    Human normal immunoglobulin for subcutaneous administration
    Other Name: Hizentra
  • Biological: IgPro10
    Human normal immunoglobulin for intravenous administration
    Other Name: Privigen
Study Arms  ICMJE
  • Experimental: IgPro20
    20% liquid formulation of human immunoglobulin for subcutaneous use
    Intervention: Biological: IgPro20
  • Experimental: IgPro10
    10% liquid formulation of human immunoglobulin for intravenous use
    Intervention: Biological: IgPro10
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2021)
27
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2019)
26
Actual Study Completion Date  ICMJE May 17, 2022
Actual Primary Completion Date May 17, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years (male or female) at time of providing written informed consent
  • Documented diagnosis of systemic sclerosis (scleroderma) according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria 2013 (diffuse cutaneous form of SSc).
  • Modified Rodnan Skin Score (mRSS) ≥ 15 and ≤ 45 at screening
  • Disease duration ≤ 5 years defined as the time from the first non-Raynaud's phenomenon manifestation
  • Capable of providing written informed consent and willing and able to adhere to all protocol requirements

Exclusion Criteria:

  • Primary rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, dermatomyositis, as determined by the investigator. Note: Subjects with fibromyalgia, secondary Sjogren's syndrome, and scleroderma-associated myopathy at screening are not excluded
  • Subject has mRSS > 2 at the potential subcutaneous (SC) infusion sites
  • History of skin condition precluding SC infusion, or clinical signs and symptoms of a chronic skin disease other than systemic sclerosis or skin manifestation of an allergic disease or other dermatological conditions that would interfere with trial assessments or compromise safety (eg, dermatitis, eczema, psoriasis)
  • Subject has clinical signs and symptoms of skin irritation (eg, pruritus, burning, erythema) or hypo/ hyperpigmentation (eg, scars, tattoos) at the potential SC infusion sites
  • Significant pulmonary arterial hypertension as documented by mean pulmonary arterial pressure > 30 mmHg on right heart catheterization requiring SC or IV prostacyclin or use of dual oral therapies
  • Forced vital capacity < 50% predicted or a diffusing capacity of the lung for carbon dioxide (DLCO) ≤ 40% predicted (corrected for hemoglobin)
  • A female who is pregnant, breastfeeding, or is a woman of childbearing potential who does not agree to use acceptable methods of contraception; a male who does agree to use acceptable methods of contraception.
  • Evidence of chronic kidney disease with an estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2 or if subject is receiving dialysis. Subjects with current confirmed diagnosis of diabetes mellitus requiring medication with an eGFR < 90 ml/min/1.73m2
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   Italy,   Poland,   United Kingdom
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT04137224
Other Study ID Numbers  ICMJE IgPro20_2001
2018-003149-41 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

CSL will consider requests to share Individual Patient Data (IPD) from systematic 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.

Current Responsible Party CSL Behring
Original Responsible Party Same as current
Current Study Sponsor  ICMJE CSL Behring
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director CSL Behring
PRS Account CSL Behring
Verification Date August 2022

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