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

Sponsor
CSL Behring (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04044690
Collaborator
(none)
126
80
2
51.4
1.6
0

Study Details

Study Description

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
  • Drug: human immunoglobulin G
  • Drug: Placebo
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 21, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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

    Primary Outcome Measures

    1. Responder Rate [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) [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 [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) [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 [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 [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 [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 [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 [Week 5 up to Week 53]

    9. Time to first achieving TIS ≥ 20, ≥ 40, and ≥ 60 points on the TIS [Week 5 up to Week 53]

    10. Percentage of subjects achieving TIS ≥ 20 points at the end of study period 2 [Up to week 53]

    11. Mean changes from baseline in individual CSMs (except muscle enzymes) and CDASI [Between Week 5 and Week 25]

    12. Mean changes in individual CSMs (except muscle enzymes) and CDASI [From week 29 to week 53]

    13. Number of subjects meeting Definition of Worsening (DOW) at least once, twice, or > twice [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 [Baseline up to Week 53]

    15. Time to meeting DOW for the first time [Baseline up to Week 53]

    16. Number of subjects meeting DOW and receiving rescue steroid treatment [Baseline up to Week 53]

    17. Percentage of subjects meeting DOW and receiving rescue steroid treatment [Baseline up to Week 53]

    18. Percentage of subjects receiving rescue steroid treatment [Baseline up to Week 25]

    19. Percentage of subjects whose rescue steroid treatment is tapered [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) [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 [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 [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 [From Week 25 up to week 53]

    24. Percentage of subjects with Treatment Emergent Adverse Events (TEAEs) [Up to week 197]

    25. Percentage of subjects with related TEAEs [Up to week 197]

    26. Percentage of subjects with serious TEAEs [Up to week 197]

    27. Rate of TEAEs per days with infusion [Up to week 197]

    28. Rate of TEAEs per days with infusion, by severity [Up to week 197]

    29. Rate of related TEAEs per days with infusion [Up to week 197]

    30. Rate of serious TEAEs per days with infusion [Up to week 197]

    31. Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% [Up to Week 25]

    32. Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% [Up to Week 25]

    33. The odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% [Up to Week 25]

    34. Number of subjects who start oral corticosteroid dose taper [Baseline up to Week 53]

    35. Percentage of subjects who start oral corticosteroid dose taper [Baseline up to Week 53]

    36. Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% [Baseline up to Week 25]

    37. Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% [Baseline up to Week 25]

    38. Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% [Baseline up to Week 53]

    39. Time to first intake of rescue corticosteroid treatment [Baseline up to Week 25]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 8401117 - Arizona Arthritis & Rheumatology Research Glendale Arizona United States 85306
    2 8401199 - Neuromuscular Research Center Phoenix Arizona United States 85028
    3 8401129 - UCLA - Rheumatology Los Angeles Los Angeles California United States 90095
    4 8401473 - RecioMed Clinical Research Network, Inc. Boynton Beach Florida United States 33472
    5 8401160 - Center For Rheumatology Fort Lauderdale Florida United States 33334
    6 8401132 - Omega Research Maitland Orlando Florida United States 32810
    7 8401107 - Morsani Center for Advanced Health Care (CAHC) Tampa Florida United States 33616
    8 8401152 - The University of Kansas Medical Center Fairway Kansas United States 66205
    9 8401476 - DS Research Louisville Kentucky United States 40241
    10 8401111 - Ochsner Clinic Foundation Baton Rouge Louisiana United States 70809
    11 8401130 - University Of Michigan Ann Arbor Michigan United States 48106
    12 8401181 - Northwell Health Physicians Great Neck New York United States 11021
    13 8400169 - HSS-Weill Medical College of Cornell University New York New York United States 10021
    14 8401487 - Ohio State University Columbus Ohio United States 43210
    15 8401131 - Paramount Medical Research & Consulting Middleburg Heights Ohio United States 44130
    16 8401486 - Oregon Health and Science University Portland Oregon United States 97239
    17 8401210 - University of Pennsylvania Philadelphia Pennsylvania United States 19104
    18 8401151 - Biomedical Science Tower Pittsburgh Pennsylvania United States 15261
    19 8401113 - Wesley Neurology Clinic Cordova Tennessee United States 38018
    20 8401474 - West Tennessee Research Institute, LLC Jackson Tennessee United States 38305
    21 8401115 - The University of Texas Medical School at Houston Houston Texas United States 77030
    22 0360094 - Murdoch University Murdoch Western Australia Australia 6150
    23 0560050 - Ghent Universit Hospital (UZ Gent) Gent Belgium 9000
    24 0560048 - Universitair Ziekenhuis (UZ) Leuven Leuven Belgium 3000
    25 0560049 - CHU de Liège - Sart Tilman Liège Belgium 4000
    26 2500146 - CHU De Dijon Hopital Du Bocage Dijon France 21079
    27 2500188 - Centre Hospitalier Regional Universitaire de Lille Lille Cedex France 59037
    28 2500133 - CHU - Hospital de la Timone Marseille France 13385
    29 2500135 - CHU Nice-Hopital Archet I Nice France 06202
    30 2500132 - Hopital Pitie-Salpetriere Paris France 75013
    31 2500144 - Hopitaux Universitaire de Strasbourg Strasbourg France 67098
    32 2760203 - Charité Berlin Germany 10117
    33 2760211 - Charité - Universitätsmedizin Berlin Berlin Germany 10117
    34 2760094 - University Essen Essen Germany 45147
    35 2760036 - University Medicine Göttingen Göttingen Germany 37075
    36 2760197 - Universitätsklinikum Hamburg-Eppendorf (UKE) Hamburg Germany 20246
    37 2760201 - Medizinische Hochschule Hannover (MHH) Hannover Germany 30625
    38 2760199 - University Hospital Köln Köln Germany 50937
    39 2760210 - University of Münster Münster Germany 48149
    40 2760212 - University Hospital Of Tuebingen Tuebingen Germany 72076
    41 2760268 - University of Ulm Ulm Germany 89081
    42 3800133 - Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia Brescia Italy 25123
    43 3800132 - Universitaria Vittorio Emanuele Catania Italy 95124
    44 3800139 - Universita degli Studi Firenze Firenze Italy 50134
    45 3800134 - Azienda Ospedaliero Universitaria Pisana Pisa Italy 56124
    46 3800135 - University of Sacred Heart Policlinico A. Gemelli Roma Italy 00168
    47 3920096 - Chukyo Hospital Nagoya Aichi Japan 457-8510
    48 3920090 - University Of Fukui Hospital Yoshida-Gun Fukui Japan 910-1193
    49 3920088 - Gunma University Hospital Maebashi City Gunma Japan 371-6511
    50 3920089 - Hokkaido University Hospital Sapporo Hokkaido Japan 060-8648
    51 3920086 - St. Marianna University Hospital Kawasaki Kanagawa Japan 216-8511
    52 3920125 - Tokyo Medical And Dental University Medical Hospital Bunkyo Tokyo Japan 113-8519
    53 3920091 - Nippon Medical School Hospital Bunkyō-Ku Tokyo Japan 113-8603
    54 3920097 - Tokyo Women's Medical University Hospital Shinjuku-Ku Tokyo Japan 162-8666
    55 3920087 - Wakayama Medical University Hospital Wakayama Japan 641-8509
    56 3920035 - Yamaguchi University Hospital Yamaguchi Japan 755-8505
    57 4840082 - CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C. Ciudad de México Distrito Federal Mexico 11850
    58 4840081 - Centro Integral en Reumatologia, SA de CV Guadalajara Jalisco Mexico 44160
    59 4840084 - Centro de Alta Especialidad en Reumatologia e Investigacion del Potosí, S.C. San Luis Potosí Mexico 78213
    60 5280065 - Amsterdam Universitair Medische Centra (UMC) Amsterdam Netherlands 1105 AZ
    61 6160106 - Specjalistyczne Gabinety Sp. z o.o Krakow Poland 30-539
    62 6160104 - Zespol Poradni Specjalistycznych REUMED, ONYKSOWA Filia nr 2 Lublin Poland 20-582
    63 6160105 - Samodzielny Publiczny Szpital Szczecin Poland 70-111
    64 6430124 - ORIS Firm Limited Liability Company Moscow Russian Federation 117321
    65 6430122 - City Clinical Hospital No. 5 Nizhniy Novgorod Russian Federation 603005
    66 6430125 - Medical Centre-Healthy Family Novosibirsk Russian Federation 630099
    67 6430120 - St. Petersburg City Rheumatological Hospital 25 Saint Petersburg Russian Federation 190068
    68 6430123 - Yaroslavl Oblast Clinical Hospital Yaroslavl Russian Federation 150007
    69 7240086 - Complejo Hospitalario Universitario A Coruña A Coruña Spain 15006
    70 7240011 - Hospital Universitario Valle de Hebron Barcelona Spain 08035
    71 7560033 - University Hospital Bern Inselspital Bern Switzerland 3010
    72 7560028 - Kantonsspital St. Gallen Saint Gallen Switzerland 9007
    73 8040053 - Cherkassy Regional Hospital Cherkasy Ukraine 18009
    74 8040055 - Mechnikov Institute of Microbiology and Immunology Kharkiv Ukraine 61029
    75 8040057 - Khmelnitskiy Regional Hospital Khmelnytskyi Ukraine 29000
    76 8040058 - State Institution National Scientific Center Strazhesko Kiev Ukraine 03151
    77 8040052 - Institute of Rheumatology Kyiv Ukraine 02081
    78 8040051 - Kyiv Railway Clinical Hospital No.2 Kyiv Ukraine 03049
    79 8040054 - Modern Clinic LLC Zaporizhia Ukraine 69005
    80 8260119 - Doncaster Royal Infirmary Doncaster United Kingdom DN2 5LT

    Sponsors and Collaborators

    • CSL Behring

    Investigators

    • Study Director: Study Director, CSL Behring

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CSL Behring
    ClinicalTrials.gov Identifier:
    NCT04044690
    Other Study ID Numbers:
    • IgPro20_3007
    • 2018-003171-35
    First Posted:
    Aug 5, 2019
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:

    Study Results

    No Results Posted as of Aug 1, 2022