Clinical trial NCT04044690: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
Official title: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dermatomyositis
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2019-08-05
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Responder Rate
timeFrame: Weeks 17, 21, and 25
Secondary outcomes:
measure: Mean Total Improvement Score (TIS)
timeFrame: Up to Week 25
measure: Mean difference (IgPro20 minus placebo) in TIS
timeFrame: Up to week 25
measure: Mean changes from Baseline in Manual Muscle Testing (MMT-8)
timeFrame: Up to week 25
measure: Mean change difference (IgPro20 minus placebo) in MMT-8
timeFrame: Up to week 25
measure: Mean changes from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score
timeFrame: Up to week 25
measure: Mean change difference (IgPro20 minus placebo) in CDASI
timeFrame: Up to week 25
measure: Mean TIS
timeFrame: Week 5 up to Week 53
measure: Percentage of subjects achieving TIS ≥ 20, ≥ 40, and ≥ 60 points
timeFrame: Week 5 up to Week 53
measure: Time to first achieving TIS ≥ 20, ≥ 40, and ≥ 60 points on the TIS
timeFrame: Week 5 up to Week 53
measure: Percentage of subjects achieving TIS ≥ 20 points at the end of study period 2
timeFrame: Up to week 53
measure: Mean changes from baseline in individual CSMs (except muscle enzymes) and CDASI
timeFrame: Between Week 5 and Week 25
measure: Mean changes in individual CSMs (except muscle enzymes) and CDASI
timeFrame: From week 29 to week 53
measure: Number of subjects meeting Definition of Worsening (DOW) at least once, twice, or > twice
timeFrame: Baseline up to Week 53
measure: Percentage of subjects meeting DOW at least once, twice, or > twice
timeFrame: Baseline up to Week 53
measure: Time to meeting DOW for the first time
timeFrame: Baseline up to Week 53
measure: Number of subjects meeting DOW and receiving rescue steroid treatment
timeFrame: Baseline up to Week 53
measure: Percentage of subjects meeting DOW and receiving rescue steroid treatment
timeFrame: Baseline up to Week 53
measure: Percentage of subjects receiving rescue steroid treatment
timeFrame: Baseline up to Week 25
measure: Percentage of subjects whose rescue steroid treatment is tapered
timeFrame: Baseline up to Week 25
measure: 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)
timeFrame: Baseline up to Week 53
measure: 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
timeFrame: Baseline up to Week 53
measure: 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
timeFrame: From Week 25 up to week 53
measure: 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
timeFrame: From Week 25 up to week 53
measure: Percentage of subjects with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 8 years
measure: Percentage of subjects with related TEAEs
timeFrame: Up to 8 years
measure: Percentage of subjects with serious TEAEs
timeFrame: Up to 8 years
measure: Rate of TEAEs per days with infusion
timeFrame: Up to 8 years
measure: Rate of TEAEs per days with infusion, by severity
timeFrame: Up to 8 years
measure: Rate of related TEAEs per days with infusion
timeFrame: Up to 8 years
measure: Rate of serious TEAEs per days with infusion
timeFrame: Up to 8 years
measure: Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%
timeFrame: Up to Week 25
measure: Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%
timeFrame: Up to Week 25
measure: The odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%
timeFrame: Up to Week 25
measure: Number of subjects who start oral corticosteroid dose taper
timeFrame: Baseline up to Week 53
measure: Percentage of subjects who start oral corticosteroid dose taper
timeFrame: Baseline up to Week 53
measure: Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%
timeFrame: Baseline up to Week 25
measure: Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%
timeFrame: Baseline up to Week 25
measure: Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%
timeFrame: Baseline up to Week 53
measure: Time to first intake of rescue corticosteroid treatment
timeFrame: Baseline up to Week 25
Other outcomes:
Locations:
city: Glendale
country: United States
facility: 8401117 - Arizona Arthritis & Rheumatology Research
state: Arizona
city: Phoenix
country: United States
facility: 8401199 - Neuromuscular Research Center
state: Arizona
city: Los Angeles
country: United States
facility: 8401129 - UCLA - Rheumatology Los Angeles
state: California
city: Boynton Beach
country: United States
facility: 8401473 - RecioMed Clinical Research Network, Inc.
state: Florida
city: Fort Lauderdale
country: United States
facility: 8401160 - Center For Rheumatology
state: Florida
city: Orlando
country: United States
facility: 8401132 - Omega Research Maitland
state: Florida
city: Tampa
country: United States
facility: 8401107 - Morsani Center for Advanced Health Care (CAHC)
state: Florida
city: Fairway
country: United States
facility: 8401152 - The University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: 8401476 - DS Research
state: Kentucky
city: Columbus
country: United States
facility: 8401487 - Ohio State University
state: Ohio
city: Portland
country: United States
facility: 8401486 - Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: 8401210 - University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 8401151 - Biomedical Science Tower
state: Pennsylvania
city: Jackson
country: United States
facility: 8401474 - West Tennessee Research Institute, LLC
state: Tennessee
city: Houston
country: United States
facility: 8401115 - The University of Texas Medical School at Houston
state: Texas
city: Ciudad Autónoma Buenos Aires
country: Argentina
facility: 0320083 - Hospital Italiano de Buenos Aires
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: 0320084 - DIM Clinica Privada
city: Buenos Aires
country: Argentina
facility: 0320081 - Fundacion Respirar
city: Tucumán
country: Argentina
facility: 0320077 - Centro Medico Privado de Reumatolgia
city: Gent
country: Belgium
facility: 0560050 - Ghent Universit Hospital (UZ Gent)
city: Leuven
country: Belgium
facility: 0560048 - Universitair Ziekenhuis (UZ) Leuven
city: Leuven
country: Belgium
facility: 0560056 - Universitair Ziekenhuis Leuven
city: Liège
country: Belgium
facility: 0560049 - CHU de Liège - Sart Tilman
city: Dijon
country: France
facility: 2500146 - CHU De Dijon Hopital Du Bocage
city: Lille Cedex
country: France
facility: 2500188 - Centre Hospitalier Regional Universitaire de Lille
city: Marseille
country: France
facility: 2500133 - CHU - Hospital de la Timone
city: Nice
country: France
facility: 2500135 - CHU Nice-Hopital Archet I
city: Paris
country: France
facility: 2500132 - Hopital Pitie-Salpetriere
city: Strasbourg
country: France
facility: 2500144 - Hopitaux Universitaire de Strasbourg
city: Berlin
country: Germany
facility: 2760203 - Charité
city: Berlin
country: Germany
facility: 2760211 - Charité - Universitätsmedizin Berlin
city: Dresden
country: Germany
facility: 2760271 - Universitatsklinikum Carl Gustav Carus TU Dresden
city: Erlangen
country: Germany
facility: 2760273 - Hautklinik des Uni-Klinikums Erlangen
city: Göttingen
country: Germany
facility: 2760036 - University Medicine Göttingen
city: Hannover
country: Germany
facility: 2760201 - Medizinische Hochschule Hannover (MHH)
city: Köln
country: Germany
facility: 2760199 - University Hospital Köln
city: Münster
country: Germany
facility: 2760210 - University of Münster
city: Tuebingen
country: Germany
facility: 2760212 - University Hospital Of Tuebingen
city: Ulm
country: Germany
facility: 2760268 - University of Ulm
city: Debrecen
country: Hungary
facility: 3480048 - University of Debrecen
city: Brescia
country: Italy
facility: 3800133 - Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia
city: Catania
country: Italy
facility: 3800132 - Universitaria Vittorio Emanuele
city: Firenze
country: Italy
facility: 3800139 - Universita degli Studi Firenze
city: Pisa
country: Italy
facility: 3800134 - Azienda Ospedaliero Universitaria Pisana
city: Nagoya
country: Japan
facility: 3920096 - Chukyo Hospital
state: Aichi
city: Yoshida-Gun
country: Japan
facility: 3920090 - University Of Fukui Hospital
state: Fukui
city: Maebashi City
country: Japan
facility: 3920088 - Gunma University Hospital
state: Gunma
city: Sapporo
country: Japan
facility: 3920089 - Hokkaido University Hospital
state: Hokkaido
city: Kawasaki
country: Japan
facility: 3920086 - St. Marianna University Hospital
state: Kanagawa
city: Bunkyo
country: Japan
facility: 3920125 - Tokyo Medical And Dental University Medical Hospital
state: Tokyo
city: Bunkyō-Ku
country: Japan
facility: 3920091 - Nippon Medical School Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: 3920097 - Tokyo Women's Medical University Hospital
state: Tokyo
city: Wakayama
country: Japan
facility: 3920087 - Wakayama Medical University Hospital
city: Yamaguchi
country: Japan
facility: 3920035 - Yamaguchi University Hospital
city: Ciudad de México
country: Mexico
facility: 4840082 - CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: 4840081 - Centro Integral en Reumatologia, SA de CV
state: Jalisco
city: San Luis Potosí
country: Mexico
facility: 4840084 - Centro de Alta Especialidad en Reumatologia e Investigacion del Potosí, S.C.
city: Lublin
country: Poland
facility: 6160104 - Zespol Poradni Specjalistycznych REUMED, ONYKSOWA Filia nr 2
city: Warszawa
country: Poland
facility: 6160117 - MedicalConcierge Centrum Medyczne
city: Moscow
country: Russian Federation
facility: 6430124 - ORIS Firm Limited Liability Company
city: Nizhniy Novgorod
country: Russian Federation
facility: 6430122 - City Clinical Hospital No. 5
city: Novosibirsk
country: Russian Federation
facility: 6430125 - Medical Centre-Healthy Family
city: Saint Petersburg
country: Russian Federation
facility: 6430120 - St. Petersburg City Rheumatological Hospital 25
city: Yaroslavl
country: Russian Federation
facility: 6430123 - Yaroslavl Oblast Clinical Hospital
city: A Coruña
country: Spain
facility: 7240086 - Complejo Hospitalario Universitario A Coruña
city: Barcelona
country: Spain
facility: 7240011 - Hospital Universitario Valle de Hebron
city: Barcelona
country: Spain
facility: 7240112 - Hospital Clinic Barcelona
city: Bern
country: Switzerland
facility: 7560033 - University Hospital Bern Inselspital
city: Saint Gallen
country: Switzerland
facility: 7560028 - Kantonsspital St. Gallen
city: Cherkasy
country: Ukraine
facility: 8040053 - Cherkassy Regional Hospital
city: Kharkiv
country: Ukraine
facility: 8040055 - Mechnikov Institute of Microbiology and Immunology
city: Khmelnytskyi
country: Ukraine
facility: 8040057 - Khmelnitskiy Regional Hospital
city: Kiev
country: Ukraine
facility: 8040058 - State Institution National Scientific Center Strazhesko
city: Kyiv
country: Ukraine
facility: 8040052 - Institute of Rheumatology
city: Kyiv
country: Ukraine
facility: 8040051 - Kyiv Railway Clinical Hospital No.2
city: Zaporizhia
country: Ukraine
facility: 8040054 - Modern Clinic LLC
Study officials:
affiliation: CSL Behring
name: Study Director
role: STUDY_DIRECTOR
References: