Study Stopped
Primary endpoint not attained
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
RECLAIIM
3 other identifiers
interventional
134
14 countries
76
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2019
Longer than P75 for phase_3
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2019
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedStudy Start
First participant enrolled
October 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2024
CompletedResults Posted
Study results publicly available
December 9, 2025
CompletedDecember 9, 2025
November 1, 2025
5.1 years
August 1, 2019
October 17, 2025
November 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Responder Rate
A responder was defined as a participant with a TIS \>= 20 points at Week 25 and at least 1 of the previous scheduled visits (Week 17 or 21), who completes 24 weeks of randomized IMP treatment without the use of rescue corticosteroid treatment. The TIS was a sum response criterion which incorporates 6 weighted international myositis assessment and clinical studies (IMACS) core set measures (CSMs) including Physician and Patient Global Disease Activity (PGA), Manual Muscle Testing-8 (MMT-8), Health Assessment Questionnaire, Muscle Enzyme, and Extramuscular Global Activity (EGA). Thresholds for minimal, moderate, and major improvement were \>= 20, \>= 40, and \>= 60 points, respectively on the TIS. Percentage of responders at Week 25 based on TIS are reported here. Multiple imputation (MI) was used to impute missing values for participants who discontinued due to the military activities in Ukraine.
At Week 25
Secondary Outcomes (33)
Mean TIS
At Week 25
Mean Changes From Baseline in MMT-8
From Baseline to Week 25
Mean Changes From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Total Activity Score (CDASI-A)
From Baseline to Week 25
Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%
At Week 25
Period 1: Mean TIS at Each Visit
At Week 5, 9, 13, 17, 21, and 25
- +28 more secondary outcomes
Study Arms (2)
IgPro20
EXPERIMENTALhuman immunoglobulin G administered subcutaneously
Placebo
PLACEBO COMPARATORhuman albumin solution administered subcutaneously
Interventions
human immunoglobulin G administered subcutaneously
contains 2% human albumin, similar excipients as IgPro20 (Hizentra), same volume, same duration, administered subcutaneously
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (76)
8401117 - Arizona Arthritis & Rheumatology Research
Glendale, Arizona, 85306, United States
8401199 - Neuromuscular Research Center
Phoenix, Arizona, 85028, United States
8401129 - UCLA - Rheumatology Los Angeles
Los Angeles, California, 90095, United States
8401473 - RecioMed Clinical Research Network, Inc.
Boynton Beach, Florida, 33472, United States
8401160 - Center For Rheumatology
Fort Lauderdale, Florida, 33334, United States
8401132 - Omega Research Maitland
Orlando, Florida, 32810, United States
8401107 - Morsani Center for Advanced Health Care (CAHC)
Tampa, Florida, 33616, United States
8401152 - The University of Kansas Medical Center
Fairway, Kansas, 66205, United States
8401476 - DS Research
Louisville, Kentucky, 40241, United States
8401487 - Ohio State University
Columbus, Ohio, 43210, United States
8401486 - Oregon Health and Science University
Portland, Oregon, 97239, United States
8401210 - University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
8401151 - Biomedical Science Tower
Pittsburgh, Pennsylvania, 15261, United States
8401474 - West Tennessee Research Institute, LLC
Jackson, Tennessee, 38305, United States
8401115 - The University of Texas Medical School at Houston
Houston, Texas, 77030, United States
0320083 - Hospital Italiano de Buenos Aires
Ciudad Autónoma Buenos Aires, Buenos Aires, C1181ACH, Argentina
0320084 - DIM Clinica Privada
Buenos Aires, B1704ETD, Argentina
0320081 - Fundacion Respirar
Buenos Aires, C1426ABP, Argentina
0320077 - Centro Medico Privado de Reumatolgia
San Miguel de Tucumán, T4000, Argentina
0560050 - Ghent Universit Hospital (UZ Gent)
Ghent, 9000, Belgium
0560048 - Universitair Ziekenhuis (UZ) Leuven
Leuven, 3000, Belgium
0560056 - Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
0560049 - CHU de Liège - Sart Tilman
Liège, 4000, Belgium
2500146 - CHU De Dijon Hopital Du Bocage
Dijon, 21079, France
2500188 - Centre Hospitalier Regional Universitaire de Lille
Lille, 59037, France
2500133 - CHU - Hospital de la Timone
Marseille, 13385, France
2500135 - CHU Nice-Hopital Archet I
Nice, 06202, France
2500132 - Hopital Pitie-Salpetriere
Paris, 75013, France
2500144 - Hopitaux Universitaire de Strasbourg
Strasbourg, 67098, France
2760203 - Charité
Berlin, 10117, Germany
2760211 - Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
2760199 - University Hospital Köln
Cologne, 50937, Germany
2760271 - Universitatsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307, Germany
2760273 - Hautklinik des Uni-Klinikums Erlangen
Erlangen, 91504, Germany
2760036 - University Medicine Göttingen
Göttingen, 37075, Germany
2760201 - Medizinische Hochschule Hannover (MHH)
Hanover, 30625, Germany
2760210 - University of Münster
Münster, 48149, Germany
2760212 - University Hospital Of Tuebingen
Tübingen, 72076, Germany
2760268 - University of Ulm
Ulm, 89081, Germany
3480048 - University of Debrecen
Debrecen, 4032, Hungary
3800133 - Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123, Italy
3800132 - Universitaria Vittorio Emanuele
Catania, 95124, Italy
3800139 - Universita degli Studi Firenze
Florence, 50134, Italy
3800134 - Azienda Ospedaliero Universitaria Pisana
Pisa, 56124, Italy
3920096 - Chukyo Hospital
Nagoya, Aichi-ken, 457-8510, Japan
3920090 - University Of Fukui Hospital
Yoshida-Gun, Fukui, 910-1193, Japan
3920088 - Gunma University Hospital
Maebashi, Gunma, 371-6511, Japan
3920089 - Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
3920086 - St. Marianna University Hospital
Kawasaki, Kanagawa, 216-8511, Japan
3920125 - Tokyo Medical And Dental University Medical Hospital
Bunkyo, Tokyo, 113-8519, Japan
3920091 - Nippon Medical School Hospital
Bunkyō-Ku, Tokyo, 113-8603, Japan
3920097 - Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo, 162-8666, Japan
3920087 - Wakayama Medical University Hospital
Wakayama, 641-8509, Japan
3920035 - Yamaguchi University Hospital
Yamaguchi, 755-8505, Japan
4840081 - Centro Integral en Reumatologia, SA de CV
Guadalajara, Jalisco, 44160, Mexico
4840082 - CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
Mexico City, Mexico City, 11850, Mexico
4840084 - Centro de Alta Especialidad en Reumatologia e Investigacion del Potosí, S.C.
San Luis Potosí City, 78213, Mexico
6160104 - Zespol Poradni Specjalistycznych REUMED, ONYKSOWA Filia nr 2
Lublin, 20-582, Poland
6160117 - MedicalConcierge Centrum Medyczne
Warsaw, 02-798, Poland
6430124 - ORIS Firm Limited Liability Company
Moscow, 117321, Russia
6430122 - City Clinical Hospital No. 5
Nizhny Novgorod, 603005, Russia
6430125 - Medical Centre-Healthy Family
Novosibirsk, 630099, Russia
6430120 - St. Petersburg City Rheumatological Hospital 25
Saint Petersburg, 190068, Russia
6430123 - Yaroslavl Oblast Clinical Hospital
Yaroslavl, 150007, Russia
7240086 - Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
7240011 - Hospital Universitario Valle de Hebron
Barcelona, 08035, Spain
7240112 - Hospital Clinic Barcelona
Barcelona, 08036, Spain
7560033 - University Hospital Bern Inselspital
Bern, 3010, Switzerland
7560028 - Kantonsspital St. Gallen
Sankt Gallen, 9007, Switzerland
8040053 - Cherkassy Regional Hospital
Cherkasy, 18009, Ukraine
8040055 - Mechnikov Institute of Microbiology and Immunology
Kharkiv, 61029, Ukraine
8040057 - Khmelnitskiy Regional Hospital
Khmelnytskyi, 29000, Ukraine
8040058 - State Institution National Scientific Center Strazhesko
Kiev, 03151, Ukraine
8040052 - Institute of Rheumatology
Kyiv, 02081, Ukraine
8040051 - Kyiv Railway Clinical Hospital No.2
Kyiv, 03049, Ukraine
8040054 - Modern Clinic LLC
Zaporizhia, 69005, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
A Good Clinical Practice (GCP) breach was identified and reported to regulatory authorities regarding insufficient safety information provided by one site for one Suspected Unexpected Serious Adverse Reaction (SUSAR) and one Adverse Event of Special Interest (AESI). The sponsor made repeated requests to obtain verification of the data, which the site did not provide. This limitation may have impacted the completeness of safety data characterization for these specific events.
Results Point of Contact
- Title
- Study Director
- Organization
- CSL Behring
Study Officials
- STUDY DIRECTOR
Study Director
CSL Behring
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2019
First Posted
August 5, 2019
Study Start
October 21, 2019
Primary Completion
December 2, 2024
Study Completion
December 2, 2024
Last Updated
December 9, 2025
Results First Posted
December 9, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, 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.
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.