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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) (RECLAIIM)

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ClinicalTrials.gov Identifier: NCT04044690
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Tracking Information
First Submitted Date  ICMJE August 1, 2019
First Posted Date  ICMJE August 5, 2019
Last Update Posted Date March 17, 2021
Actual Study Start Date  ICMJE October 21, 2019
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2019)
Responder Rate [ Time Frame: Weeks 17, 21, and 25 ]
A responder is defined as a subject with a total improvement score (TIS) ≥ 20 points at Week 25 and at least 1 of the previous scheduled visits (Week 17 or Week 21), who completes 24 weeks of randomized investigational medicinal product (IMP) treatment without the use of rescue corticosteroid treatment. The TIS is a sum response criterion which incorporates 6 weighted IMACS core set measures (CSMs). Thresholds for minimal, moderate, and major improvement were ≥ 20, ≥ 40, and ≥ 60 points on the TIS.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2020)
  • Mean Total Improvement Score (TIS) [ Time Frame: Up to Week 25 ]
    The TIS is a sum response criterion which incorporates 6 weighted IMACS core set measures (CSMs). A total improvement score (range 0 to 100), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were ≥ 20, ≥ 40, and ≥ 60 points on the TIS.
  • Mean difference (IgPro20 minus placebo) in TIS [ Time Frame: Up to week 25 ]
    The TIS is a sum response criterion which incorporates 6 weighted IMACS core set measures (CSMs). A total improvement score (range 0 to 100), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were ≥ 20, ≥ 40, and ≥ 60 points on the TIS.
  • Mean changes from Baseline in Manual Muscle Testing (MMT-8) [ Time Frame: Up to week 25 ]
    MMT-8 is a set of 8 designated muscles which will be tested bilaterally (potential score 0 to 150): 7 biaxial muscles with potential score 0 to140 and 1 axial (neck flexors) with potential score 0 to10. Improvement is documented with an increase in score.
  • Mean change difference (IgPro20 minus placebo) in MMT-8 [ Time Frame: Up to week 25 ]
    MMT-8 is a set of 8 designated muscles which will be tested bilaterally (potential score 0 to 150): 7 biaxial muscles with potential score 0 to140 and 1 axial (neck flexors) with potential score 0 to10. Improvement is documented with an increase in score.
  • Mean changes from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score [ Time Frame: Up to week 25 ]
    The CDASI in its modified version (v2) is a validated tool of skin disease activity (3 items) and damage (3 items) assessment. Scores range from 0-100 for activity and from 0-32 for damage. Improvement is documented with a decrease in score.
  • Mean change difference (IgPro20 minus placebo) in CDASI [ Time Frame: Up to week 25 ]
    The CDASI in its modified version (v2) is a validated tool of skin disease activity (3 items) and damage (3 items) assessment. Scores range from 0-100 for activity and from 0-32 for damage. Improvement is documented with a decrease in score.
  • Mean TIS [ Time Frame: Week 5 up to Week 53 ]
    The TIS is a sum response criterion which incorporates 6 weighted IMACS core set measures (CSMs). A total improvement score (range 0 to 100), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were ≥ 20, ≥ 40, and ≥ 60 points on the TIS.
  • Percentage of subjects achieving TIS ≥ 20, ≥ 40, and ≥ 60 points [ Time Frame: Week 5 up to Week 53 ]
  • Time to first achieving TIS ≥ 20, ≥ 40, and ≥ 60 points on the TIS [ Time Frame: Week 5 up to Week 53 ]
  • Percentage of subjects achieving TIS ≥ 20 points at the end of study period 2 [ Time Frame: Up to week 53 ]
  • Mean changes from baseline in individual CSMs (except muscle enzymes) and CDASI [ Time Frame: Between Week 5 and Week 25 ]
  • Mean changes in individual CSMs (except muscle enzymes) and CDASI [ Time Frame: From week 29 to week 53 ]
  • Number of subjects meeting Definition of Worsening (DOW) at least once, twice, or > twice [ Time Frame: Baseline up to Week 53 ]
    The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart:
    • Physician Global Activity Assessment Visual Analog Scale (VAS) worsening ≥ 2 cm* and Manual Muscle Test (MMT)-8 worsening ≥ absolute 10%, or
    • Extramuscular Global Assessment worsening ≥ 2 cm on the Myositis Disease Activity Assessment Tool (MDAAT) VAS, or
    • Any 3 of 6 CSM worsening by ≥ absolute 20%
  • Percentage of subjects meeting DOW at least once, twice, or > twice [ Time Frame: Baseline up to Week 53 ]
  • Time to meeting DOW for the first time [ Time Frame: Baseline up to Week 53 ]
  • Number of subjects meeting DOW and receiving rescue steroid treatment [ Time Frame: Baseline up to Week 53 ]
  • Percentage of subjects meeting DOW and receiving rescue steroid treatment [ Time Frame: Baseline up to Week 53 ]
  • Percentage of subjects receiving rescue steroid treatment [ Time Frame: Baseline up to Week 25 ]
  • Percentage of subjects whose rescue steroid treatment is tapered [ Time Frame: Baseline up to Week 25 ]
  • Number of subjects having at least 1 level, 2 levels, and more than 2 levels of improvement from Baseline in mobility, self-care, and usual activities domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) [ Time Frame: Baseline up to Week 53 ]
    The subject will select which best describes his own health state at the study visit in the following dimensions: Mobility, Self-care, Usual Activities. The subject will also select a point on a scale drawn like a thermometer to indicate how good or bad the health state is, with best state as "100" and worst state as "0."
  • Percentage of subjects having at least 1 level, 2 levels, and more than 2 levels of improvement from Baseline in mobility, self-care, and usual activities domains of EQ-5D-5L [ Time Frame: Baseline up to Week 53 ]
  • Number of subjects having no reduction in levels, at least 1 level, 2 levels, and more than 2 levels of improvement in mobility, self-care, and usual activities domains of EQ-5D-5L from Week 25 [ Time Frame: From Week 25 up to week 53 ]
  • Percentage of subjects having no reduction in levels, at least 1 level, 2 levels, and more than 2 levels of improvement in mobility, self-care, and usual activities domains of EQ-5D-5L from Week 25 [ Time Frame: From Week 25 up to week 53 ]
  • Percentage of subjects with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to week 197 ]
  • Percentage of subjects with related TEAEs [ Time Frame: Up to week 197 ]
  • Percentage of subjects with serious TEAEs [ Time Frame: Up to week 197 ]
  • Rate of TEAEs per days with infusion [ Time Frame: Up to week 197 ]
  • Rate of TEAEs per days with infusion, by severity [ Time Frame: Up to week 197 ]
  • Rate of related TEAEs per days with infusion [ Time Frame: Up to week 197 ]
  • Rate of serious TEAEs per days with infusion [ Time Frame: Up to week 197 ]
  • Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% [ Time Frame: Up to Week 25 ]
  • Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% [ Time Frame: Up to Week 25 ]
  • The odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% [ Time Frame: Up to Week 25 ]
  • Number of subjects who start oral corticosteroid dose taper [ Time Frame: Baseline up to Week 53 ]
  • Percentage of subjects who start oral corticosteroid dose taper [ Time Frame: Baseline up to Week 53 ]
  • Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% [ Time Frame: Baseline up to Week 25 ]
  • Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% [ Time Frame: Baseline up to Week 25 ]
  • Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% [ Time Frame: Baseline up to Week 53 ]
  • Time to first intake of rescue corticosteroid treatment [ Time Frame: Baseline up to Week 25 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2019)
  • Mean Total Improvement Score (TIS) [ Time Frame: Up to Week 25 ]
    The TIS is a sum response criterion which incorporates 6 weighted IMACS core set measures (CSMs).
  • Mean difference (IgPro20 minus placebo) in TIS [ Time Frame: Up to week 25 ]
  • Mean changes from Baseline in Manual Muscle Testing (MMT-8) [ Time Frame: Up to week 25 ]
    MMT-8 is a set of 8 designated muscles which will be tested bilaterally (potential score 0 to 150): 7 biaxial muscles with potential score 0 to140 and 1 axial (neck flexors) with potential score 0 to10. Improvement is documented with an increase in score.
  • Mean change difference (IgPro20 minus placebo) in MMT-8 [ Time Frame: Up to week 25 ]
  • Mean changes from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score [ Time Frame: Up to week 25 ]
    The CDASI in its modified version (v2) is a validated tool of skin disease activity (3 items) and damage (3 items) assessment. Improvement is documented with a decrease in score.
  • Mean change difference (IgPro20 minus placebo) in CDASI [ Time Frame: Up to week 25 ]
  • Mean TIS throughout the study [ Time Frame: Baseline up to week 53 ]
  • Percentage of subjects achieving TIS ≥ 20, ≥ 40, and ≥ 60 points [ Time Frame: Up to week 53 ]
  • Time to first achieving TIS ≥ 20, ≥ 40, and ≥ 60 points on the TIS [ Time Frame: Up to week 53 ]
  • Percentage of subjects achieving TIS ≥ 20 points at the end of the study participation [ Time Frame: Up to week 53 ]
  • Mean changes from baseline in individual CSMs (except muscle enzymes and CDASI) [ Time Frame: Baseline Up to week 25 ]
  • Mean changes in individual CSMs (except muscle enzymes and CDASI) from Week 25 [ Time Frame: From week 25 to week 53 ]
  • Number of subjects meeting Definition of Worsening (DOW) at least once, twice, or > twice [ Time Frame: From week 9 up to week 25 ]
    The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart:
    • Physician Global Activity Assessment Visual Analog Scale (VAS) worsening ≥ 2 cm* and Manual Muscle Test (MMT)-8 worsening ≥ absolute 10%, or
    • Extramuscular Global Assessment worsening ≥ 2 cm on the Myositis Disease Activity Assessment Tool (MDAAT) VAS, or
    • Any 3 of 6 CSM worsening by ≥ absolute 20%
  • Percentage of subjects meeting DOW at least once, twice, or > twice [ Time Frame: From week 9 up to week 25 ]
  • Time to meeting DOW for the first time [ Time Frame: From week 9 up to week 25 ]
  • Number of subjects meeting DOW and receiving rescue steroid treatment [ Time Frame: From week 9 up to week 25 ]
  • Percentage of subjects meeting DOW and receiving rescue steroid treatment [ Time Frame: From week 9 up to week 25 ]
  • Percentage of subjects receiving rescue steroid treatment [ Time Frame: From week 9 up to week 25 ]
  • Percentage of subjects whose rescue steroid treatment is tapered [ Time Frame: From week 9 up to week 25 ]
  • Number of subjects having at least 1 level, 2 levels, and more than 2 levels of improvement from Baseline in mobility, self-care, and usual activities domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) [ Time Frame: Up to week 25 ]
    The subject will select which best describes his own health state at the study visit in the following dimensions: Mobility, Self-care, Usual Activities. The subject will also select a point on a scale drawn like a thermometer to indicate how good or bad the health state is, with best state as "100" and worst state as "0."
  • Percentage of subjects having at least 1 level, 2 levels, and more than 2 levels of improvement from Baseline in mobility, self-care, and usual activities domains of EQ-5D-5L [ Time Frame: Up to week 25 ]
  • Number of subjects having no reduction in levels, at least 1 level, 2 levels, and more than 2 levels of improvement in mobility, self-care, and usual activities domains of EQ-5D-5L from Week 25 [ Time Frame: From Week 25 up to week 53 ]
  • Percentage of subjects having no reduction in levels, at least 1 level, 2 levels, and more than 2 levels of improvement in mobility, self-care, and usual activities domains of EQ-5D-5L from Week 25 [ Time Frame: From Week 25 up to week 53 ]
  • Percentage of subjects with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to week 56 ]
  • Percentage of subjects with related TEAEs [ Time Frame: Up to week 56 ]
  • Percentage of subjects with serious TEAEs [ Time Frame: Up to week 56 ]
  • Rate of TEAEs per infusion [ Time Frame: Up to week 56 ]
  • Rate of TEAEs per infusion, by severity [ Time Frame: Up to week 56 ]
  • Rate of related TEAEs per infusion [ Time Frame: Up to week 56 ]
  • Rate of serious TEAEs per infusion [ Time Frame: Up to week 56 ]
  • Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% [ Time Frame: Up to Week 25 ]
  • Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% [ Time Frame: Up to Week 25 ]
  • The odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% [ Time Frame: Up to Week 25 ]
  • Number of subjects who start oral corticosteroid dose taper [ Time Frame: Up to Week 25 ]
  • Percentage of subjects who start oral corticosteroid dose taper [ Time Frame: Up to Week 25 ]
  • Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% [ Time Frame: Up to Week 25 ]
  • Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% [ Time Frame: Up to Week 25 ]
  • Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% [ Time Frame: Up to Week 53 ]
  • Time to first intake of rescue corticosteroid treatment [ Time Frame: Week 9 up to Week 25 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
Official Title  ICMJE A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study
Brief Summary This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of IgPro20 subcutaneous (SC) doses in comparison to placebo in adult subjects with DM, as measured by responder status based on Total Improvement Score (TIS) assessments.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dermatomyositis
Intervention  ICMJE
  • Drug: human immunoglobulin G
    human immunoglobulin G administered subcutaneously
    Other Names:
    • IgPro20
    • Hizentra
  • Drug: Placebo
    contains 2% human albumin, similar excipients as IgPro20 (Hizentra), same volume, same duration, administered subcutaneously
Study Arms  ICMJE
  • Experimental: IgPro20
    human immunoglobulin G administered subcutaneously
    Intervention: Drug: human immunoglobulin G
  • Placebo Comparator: Placebo
    human albumin solution administered subcutaneously
    Intervention: Drug: 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: August 1, 2019)
126
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2024
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects ≥ 18 years of age
  • Diagnosis of at least probable idiopathic inflammatory myopathies (IIM) per European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria which includes confirmation of dermatomyositis (DM) rash/manifestation, disease activity defined by presence of DM rash / manifestation or an objective disease activity measure
  • Disease severity defined by Physician global activity visual analog scale (VAS) with a minimum value of 2.0 cm on a 10 cm scale and MMT-8 ≤ 142 or CDASI total activity score ≥ 14.
  • Corticosteroid daily dose less than that or equal to 20 mg prednisolone equivalent

Exclusion Criteria:

  • Cancer-associated myositis
  • Evidence of active malignant disease or malignancies diagnosed within the previous 5 years
  • Physician Global Damage score ≥ 3, or clinically relevant improvement between Screening Visit and Baseline
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 Australia,   Belgium,   France,   Germany,   Italy,   Japan,   Mexico,   Poland,   Russian Federation,   Spain,   Switzerland,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04044690
Other Study ID Numbers  ICMJE IgPro20_3007
2018-003171-35 ( 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 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.

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 March 2021

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