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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 : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dermatomyositis Drug: human immunoglobulin G Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study
Actual Study Start Date : October 21, 2019
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : November 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: IgPro20
human immunoglobulin G administered subcutaneously
 Drug: human immunoglobulin G
human immunoglobulin G administered subcutaneously
Other Names:
  • IgPro20
  • Hizentra
Placebo Comparator: Placebo
human albumin solution administered subcutaneously
 Drug: Placebo
contains 2% human albumin, similar excipients as IgPro20 (Hizentra), same volume, same duration, administered subcutaneously


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Percentage of subjects achieving TIS ≥ 20, ≥ 40, and ≥ 60 points [ Time Frame: Week 5 up to Week 53 ]
  9. Time to first achieving TIS ≥ 20, ≥ 40, and ≥ 60 points on the TIS [ Time Frame: Week 5 up to Week 53 ]
  10. Percentage of subjects achieving TIS ≥ 20 points at the end of study period 2 [ Time Frame: Up to week 53 ]
  11. Mean changes from baseline in individual CSMs (except muscle enzymes) and CDASI [ Time Frame: Between Week 5 and Week 25 ]
  12. Mean changes in individual CSMs (except muscle enzymes) and CDASI [ Time Frame: From week 29 to week 53 ]
  13. 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%

  14. Percentage of subjects meeting DOW at least once, twice, or > twice [ Time Frame: Baseline up to Week 53 ]
  15. Time to meeting DOW for the first time [ Time Frame: Baseline up to Week 53 ]
  16. Number of subjects meeting DOW and receiving rescue steroid treatment [ Time Frame: Baseline up to Week 53 ]
  17. Percentage of subjects meeting DOW and receiving rescue steroid treatment [ Time Frame: Baseline up to Week 53 ]
  18. Percentage of subjects receiving rescue steroid treatment [ Time Frame: Baseline up to Week 25 ]
  19. Percentage of subjects whose rescue steroid treatment is tapered [ Time Frame: Baseline up to Week 25 ]
  20. 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."

  21. 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 ]
  22. 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 ]
  23. 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 ]
  24. Percentage of subjects with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to week 197 ]
  25. Percentage of subjects with related TEAEs [ Time Frame: Up to week 197 ]
  26. Percentage of subjects with serious TEAEs [ Time Frame: Up to week 197 ]
  27. Rate of TEAEs per days with infusion [ Time Frame: Up to week 197 ]
  28. Rate of TEAEs per days with infusion, by severity [ Time Frame: Up to week 197 ]
  29. Rate of related TEAEs per days with infusion [ Time Frame: Up to week 197 ]
  30. Rate of serious TEAEs per days with infusion [ Time Frame: Up to week 197 ]
  31. Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% [ Time Frame: Up to Week 25 ]
  32. Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% [ Time Frame: Up to Week 25 ]
  33. The odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% [ Time Frame: Up to Week 25 ]
  34. Number of subjects who start oral corticosteroid dose taper [ Time Frame: Baseline up to Week 53 ]
  35. Percentage of subjects who start oral corticosteroid dose taper [ Time Frame: Baseline up to Week 53 ]
  36. Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% [ Time Frame: Baseline up to Week 25 ]
  37. Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% [ Time Frame: Baseline up to Week 25 ]
  38. Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% [ Time Frame: Baseline up to Week 53 ]
  39. Time to first intake of rescue corticosteroid treatment [ Time Frame: Baseline up to Week 25 ]

Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT04044690


Contacts
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Contact: Trial Registration Coordinator 610-878-4000 clinicaltrials@cslbehring.com

Locations
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Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Study Director CSL Behring
More Information
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT04044690    
Other Study ID Numbers: IgPro20_3007
2018-003171-35 ( EudraCT Number )
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
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
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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Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
 Skin Diseases
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs