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

Dermatomyositis Clinical Trial

— RECLAIIM  

Official title:

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04044690
• Other study ID #: IgPro20_3007
• Secondary ID: 2018-003171-35
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 21, 2019
• Est. completion date: November 2027

Study information

• Verified date: April 2024
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: November 2027
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatomyositis

Intervention

Drug:
• human immunoglobulin G
human immunoglobulin G administered subcutaneously
• Placebo
contains 2% human albumin, similar excipients as IgPro20 (Hizentra), same volume, same duration, administered subcutaneously

Locations

Country	Name	City	State
Argentina	0320081 - Fundacion Respirar	Buenos Aires
Argentina	0320084 - DIM Clinica Privada	Buenos Aires
Argentina	0320083 - Hospital Italiano de Buenos Aires	Ciudad Autónoma Buenos Aires	Buenos Aires
Argentina	0320077 - Centro Medico Privado de Reumatolgia	Tucumán
Belgium	0560050 - Ghent Universit Hospital (UZ Gent)	Gent
Belgium	0560048 - Universitair Ziekenhuis (UZ) Leuven	Leuven
Belgium	0560056 - Universitair Ziekenhuis Leuven	Leuven
Belgium	0560049 - CHU de Liège - Sart Tilman	Liège
France	2500146 - CHU De Dijon Hopital Du Bocage	Dijon
France	2500188 - Centre Hospitalier Regional Universitaire de Lille	Lille Cedex
France	2500133 - CHU - Hospital de la Timone	Marseille
France	2500135 - CHU Nice-Hopital Archet I	Nice
France	2500132 - Hopital Pitie-Salpetriere	Paris
France	2500144 - Hopitaux Universitaire de Strasbourg	Strasbourg
Germany	2760203 - Charité	Berlin
Germany	2760211 - Charité - Universitätsmedizin Berlin	Berlin
Germany	2760271 - Universitatsklinikum Carl Gustav Carus TU Dresden	Dresden
Germany	2760273 - Hautklinik des Uni-Klinikums Erlangen	Erlangen
Germany	2760036 - University Medicine Göttingen	Göttingen
Germany	2760201 - Medizinische Hochschule Hannover (MHH)	Hannover
Germany	2760199 - University Hospital Köln	Köln
Germany	2760210 - University of Münster	Münster
Germany	2760212 - University Hospital Of Tuebingen	Tuebingen
Germany	2760268 - University of Ulm	Ulm
Hungary	3480048 - University of Debrecen	Debrecen
Italy	3800133 - Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia	Brescia
Italy	3800132 - Universitaria Vittorio Emanuele	Catania
Italy	3800139 - Universita degli Studi Firenze	Firenze
Italy	3800134 - Azienda Ospedaliero Universitaria Pisana	Pisa
Japan	3920125 - Tokyo Medical And Dental University Medical Hospital	Bunkyo	Tokyo
Japan	3920091 - Nippon Medical School Hospital	Bunkyo-Ku	Tokyo
Japan	3920086 - St. Marianna University Hospital	Kawasaki	Kanagawa
Japan	3920088 - Gunma University Hospital	Maebashi City	Gunma
Japan	3920096 - Chukyo Hospital	Nagoya	Aichi
Japan	3920089 - Hokkaido University Hospital	Sapporo	Hokkaido
Japan	3920097 - Tokyo Women's Medical University Hospital	Shinjuku-Ku	Tokyo
Japan	3920087 - Wakayama Medical University Hospital	Wakayama
Japan	3920035 - Yamaguchi University Hospital	Yamaguchi
Japan	3920090 - University Of Fukui Hospital	Yoshida-Gun	Fukui
Mexico	4840082 - CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.	Ciudad de México	Distrito Federal
Mexico	4840081 - Centro Integral en Reumatologia, SA de CV	Guadalajara	Jalisco
Mexico	4840084 - Centro de Alta Especialidad en Reumatologia e Investigacion del Potosí, S.C.	San Luis Potosí
Poland	6160104 - Zespol Poradni Specjalistycznych REUMED, ONYKSOWA Filia nr 2	Lublin
Poland	6160117 - MedicalConcierge Centrum Medyczne	Warszawa
Russian Federation	6430124 - ORIS Firm Limited Liability Company	Moscow
Russian Federation	6430122 - City Clinical Hospital No. 5	Nizhniy Novgorod
Russian Federation	6430125 - Medical Centre-Healthy Family	Novosibirsk
Russian Federation	6430120 - St. Petersburg City Rheumatological Hospital 25	Saint Petersburg
Russian Federation	6430123 - Yaroslavl Oblast Clinical Hospital	Yaroslavl
Spain	7240086 - Complejo Hospitalario Universitario A Coruña	A Coruña
Spain	7240011 - Hospital Universitario Valle de Hebron	Barcelona
Spain	7240112 - Hospital Clinic Barcelona	Barcelona
Switzerland	7560033 - University Hospital Bern Inselspital	Bern
Switzerland	7560028 - Kantonsspital St. Gallen	Saint Gallen
Ukraine	8040053 - Cherkassy Regional Hospital	Cherkasy
Ukraine	8040055 - Mechnikov Institute of Microbiology and Immunology	Kharkiv
Ukraine	8040057 - Khmelnitskiy Regional Hospital	Khmelnytskyi
Ukraine	8040058 - State Institution National Scientific Center Strazhesko	Kiev
Ukraine	8040051 - Kyiv Railway Clinical Hospital No.2	Kyiv
Ukraine	8040052 - Institute of Rheumatology	Kyiv
Ukraine	8040054 - Modern Clinic LLC	Zaporizhia
United States	8401473 - RecioMed Clinical Research Network, Inc.	Boynton Beach	Florida
United States	8401487 - Ohio State University	Columbus	Ohio
United States	8401152 - The University of Kansas Medical Center	Fairway	Kansas
United States	8401160 - Center For Rheumatology	Fort Lauderdale	Florida
United States	8401117 - Arizona Arthritis & Rheumatology Research	Glendale	Arizona
United States	8401115 - The University of Texas Medical School at Houston	Houston	Texas
United States	8401474 - West Tennessee Research Institute, LLC	Jackson	Tennessee
United States	8401129 - UCLA - Rheumatology Los Angeles	Los Angeles	California
United States	8401476 - DS Research	Louisville	Kentucky
United States	8401132 - Omega Research Maitland	Orlando	Florida
United States	8401210 - University of Pennsylvania	Philadelphia	Pennsylvania
United States	8401199 - Neuromuscular Research Center	Phoenix	Arizona
United States	8401151 - Biomedical Science Tower	Pittsburgh	Pennsylvania
United States	8401486 - Oregon Health and Science University	Portland	Oregon
United States	8401107 - Morsani Center for Advanced Health Care (CAHC)	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  France,  Germany,  Hungary,  Italy,  Japan,  Mexico,  Poland,  Russian Federation,  Spain,  Switzerland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder Rate	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.	Weeks 17, 21, and 25
Secondary	Mean Total Improvement Score (TIS)	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.	Up to Week 25
Secondary	Mean difference (IgPro20 minus placebo) in TIS	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.	Up to week 25
Secondary	Mean changes from Baseline in Manual Muscle Testing (MMT-8)	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.	Up to week 25
Secondary	Mean change difference (IgPro20 minus placebo) in MMT-8	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.	Up to week 25
Secondary	Mean changes from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score	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.	Up to week 25
Secondary	Mean change difference (IgPro20 minus placebo) in CDASI	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.	Up to week 25
Secondary	Mean TIS	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.	Week 5 up to Week 53
Secondary	Percentage of subjects achieving TIS = 20, = 40, and = 60 points		Week 5 up to Week 53
Secondary	Time to first achieving TIS = 20, = 40, and = 60 points on the TIS		Week 5 up to Week 53
Secondary	Percentage of subjects achieving TIS = 20 points at the end of study period 2		Up to week 53
Secondary	Mean changes from baseline in individual CSMs (except muscle enzymes) and CDASI		Between Week 5 and Week 25
Secondary	Mean changes in individual CSMs (except muscle enzymes) and CDASI		From week 29 to week 53
Secondary	Number of subjects meeting Definition of Worsening (DOW) at least once, twice, or > twice	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%	Baseline up to Week 53
Secondary	Percentage of subjects meeting DOW at least once, twice, or > twice		Baseline up to Week 53
Secondary	Time to meeting DOW for the first time		Baseline up to Week 53
Secondary	Number of subjects meeting DOW and receiving rescue steroid treatment		Baseline up to Week 53
Secondary	Percentage of subjects meeting DOW and receiving rescue steroid treatment		Baseline up to Week 53
Secondary	Percentage of subjects receiving rescue steroid treatment		Baseline up to Week 25
Secondary	Percentage of subjects whose rescue steroid treatment is tapered		Baseline up to Week 25
Secondary	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)	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."	Baseline up to Week 53
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of subjects with Treatment Emergent Adverse Events (TEAEs)		Up to 8 years
Secondary	Percentage of subjects with related TEAEs		Up to 8 years
Secondary	Percentage of subjects with serious TEAEs		Up to 8 years
Secondary	Rate of TEAEs per days with infusion		Up to 8 years
Secondary	Rate of TEAEs per days with infusion, by severity		Up to 8 years
Secondary	Rate of related TEAEs per days with infusion		Up to 8 years
Secondary	Rate of serious TEAEs per days with infusion		Up to 8 years
Secondary	Number of subjects who are able to reduce the oral corticosteroid dose by = 25%		Up to Week 25
Secondary	Percentage of subjects who are able to reduce the oral corticosteroid dose by = 25%		Up to Week 25
Secondary	The odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by = 25%		Up to Week 25
Secondary	Number of subjects who start oral corticosteroid dose taper		Baseline up to Week 53
Secondary	Percentage of subjects who start oral corticosteroid dose taper		Baseline up to Week 53
Secondary	Number of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75%		Baseline up to Week 25
Secondary	Percentage of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75%		Baseline up to Week 25
Secondary	Number of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75%		Baseline up to Week 53
Secondary	Time to first intake of rescue corticosteroid treatment		Baseline up to Week 25