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

November 24, 2025 updated by: CSL Behring

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1704ETD
        • 0320084 - DIM Clinica Privada
      • Buenos Aires, Argentina, C1426ABP
        • 0320081 - Fundacion Respirar
      • San Miguel de Tucumán, Argentina, T4000
        • 0320077 - Centro Medico Privado de Reumatolgia
    • Buenos Aires
      • Ciudad Autónoma Buenos Aires, Buenos Aires, Argentina, C1181ACH
        • 0320083 - Hospital Italiano de Buenos Aires
  • Belgium
      • Ghent, Belgium, 9000
        • 0560050 - Ghent Universit Hospital (UZ Gent)
      • Leuven, Belgium, 3000
        • 0560048 - Universitair Ziekenhuis (UZ) Leuven
      • Leuven, Belgium, 3000
        • 0560056 - Universitair Ziekenhuis Leuven
      • Liège, Belgium, 4000
        • 0560049 - CHU de Liège - Sart Tilman
  • France
      • Dijon, France, 21079
        • 2500146 - CHU De Dijon Hopital Du Bocage
      • Lille, France, 59037
        • 2500188 - Centre Hospitalier Regional Universitaire de Lille
      • Marseille, France, 13385
        • 2500133 - CHU - Hospital de la Timone
      • Nice, France, 06202
        • 2500135 - CHU Nice-Hopital Archet I
      • Paris, France, 75013
        • 2500132 - Hopital Pitie-Salpetriere
      • Strasbourg, France, 67098
        • 2500144 - Hopitaux Universitaire de Strasbourg
  • Germany
      • Berlin, Germany, 10117
        • 2760203 - Charité
      • Berlin, Germany, 10117
        • 2760211 - Charité - Universitätsmedizin Berlin
      • Cologne, Germany, 50937
        • 2760199 - University Hospital Köln
      • Dresden, Germany, 01307
        • 2760271 - Universitatsklinikum Carl Gustav Carus TU Dresden
      • Erlangen, Germany, 91504
        • 2760273 - Hautklinik des Uni-Klinikums Erlangen
      • Göttingen, Germany, 37075
        • 2760036 - University Medicine Göttingen
      • Hanover, Germany, 30625
        • 2760201 - Medizinische Hochschule Hannover (MHH)
      • Münster, Germany, 48149
        • 2760210 - University of Münster
      • Tübingen, Germany, 72076
        • 2760212 - University Hospital Of Tuebingen
      • Ulm, Germany, 89081
        • 2760268 - University of Ulm
  • Hungary
      • Debrecen, Hungary, 4032
        • 3480048 - University of Debrecen
  • Italy
      • Brescia, Italy, 25123
        • 3800133 - Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia
      • Catania, Italy, 95124
        • 3800132 - Universitaria Vittorio Emanuele
      • Florence, Italy, 50134
        • 3800139 - Universita degli Studi Firenze
      • Pisa, Italy, 56124
        • 3800134 - Azienda Ospedaliero Universitaria Pisana
  • Japan
      • Wakayama, Japan, 641-8509
        • 3920087 - Wakayama Medical University Hospital
      • Yamaguchi, Japan, 755-8505
        • 3920035 - Yamaguchi University Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 457-8510
        • 3920096 - Chukyo Hospital
    • Fukui
      • Yoshida-Gun, Fukui, Japan, 910-1193
        • 3920090 - University Of Fukui Hospital
    • Gunma
      • Maebashi, Gunma, Japan, 371-6511
        • 3920088 - Gunma University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • 3920089 - Hokkaido University Hospital
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • 3920086 - St. Marianna University Hospital
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8519
        • 3920125 - Tokyo Medical And Dental University Medical Hospital
      • Bunkyō-Ku, Tokyo, Japan, 113-8603
        • 3920091 - Nippon Medical School Hospital
      • Shinjuku-Ku, Tokyo, Japan, 162-8666
        • 3920097 - Tokyo Women's Medical University Hospital
  • Mexico
      • San Luis Potosí City, Mexico, 78213
        • 4840084 - Centro de Alta Especialidad en Reumatologia e Investigacion del Potosí, S.C.
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • 4840081 - Centro Integral en Reumatologia, SA de CV
    • Mexico City
      • Mexico City, Mexico City, Mexico, 11850
        • 4840082 - CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
  • Poland
      • Lublin, Poland, 20-582
        • 6160104 - Zespol Poradni Specjalistycznych REUMED, ONYKSOWA Filia nr 2
      • Warsaw, Poland, 02-798
        • 6160117 - MedicalConcierge Centrum Medyczne
  • Russia
      • Moscow, Russia, 117321
        • 6430124 - ORIS Firm Limited Liability Company
      • Nizhny Novgorod, Russia, 603005
        • 6430122 - City Clinical Hospital No. 5
      • Novosibirsk, Russia, 630099
        • 6430125 - Medical Centre-Healthy Family
      • Saint Petersburg, Russia, 190068
        • 6430120 - St. Petersburg City Rheumatological Hospital 25
      • Yaroslavl, Russia, 150007
        • 6430123 - Yaroslavl Oblast Clinical Hospital
  • Spain
      • A Coruña, Spain, 15006
        • 7240086 - Complejo Hospitalario Universitario A Coruña
      • Barcelona, Spain, 08035
        • 7240011 - Hospital Universitario Valle de Hebron
      • Barcelona, Spain, 08036
        • 7240112 - Hospital Clinic Barcelona
  • Switzerland
      • Bern, Switzerland, 3010
        • 7560033 - University Hospital Bern Inselspital
      • Sankt Gallen, Switzerland, 9007
        • 7560028 - Kantonsspital St. Gallen
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • 8040053 - Cherkassy Regional Hospital
      • Kharkiv, Ukraine, 61029
        • 8040055 - Mechnikov Institute of Microbiology and Immunology
      • Khmelnytskyi, Ukraine, 29000
        • 8040057 - Khmelnitskiy Regional Hospital
      • Kiev, Ukraine, 03151
        • 8040058 - State Institution National Scientific Center Strazhesko
      • Kyiv, Ukraine, 02081
        • 8040052 - Institute of Rheumatology
      • Kyiv, Ukraine, 03049
        • 8040051 - Kyiv Railway Clinical Hospital No.2
      • Zaporizhia, Ukraine, 69005
        • 8040054 - Modern Clinic LLC
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • 8401117 - Arizona Arthritis & Rheumatology Research
      • Phoenix, Arizona, United States, 85028
        • 8401199 - Neuromuscular Research Center
    • California
      • Los Angeles, California, United States, 90095
        • 8401129 - UCLA - Rheumatology Los Angeles
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • 8401473 - RecioMed Clinical Research Network, Inc.
      • Fort Lauderdale, Florida, United States, 33334
        • 8401160 - Center For Rheumatology
      • Orlando, Florida, United States, 32810
        • 8401132 - Omega Research Maitland
      • Tampa, Florida, United States, 33616
        • 8401107 - Morsani Center for Advanced Health Care (CAHC)
    • Kansas
      • Fairway, Kansas, United States, 66205
        • 8401152 - The University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • 8401476 - DS Research
    • Ohio
      • Columbus, Ohio, United States, 43210
        • 8401487 - Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • 8401486 - Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • 8401210 - University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • 8401151 - Biomedical Science Tower
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • 8401474 - West Tennessee Research Institute, LLC
    • Texas
      • Houston, Texas, United States, 77030
        • 8401115 - The University of Texas Medical School at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IgPro20
human immunoglobulin G administered subcutaneously
Drug: human immunoglobulin G
human immunoglobulin G administered subcutaneously
Other Names:
  • Hizentra
  • IgPro20
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Responder Rate
Time Frame: At Week 25
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean TIS
Time Frame: At Week 25
The TIS was a sum response criterion which incorporates 6 weighted IMACS CSMs including Physician and PGA, MMT-8, Health Assessment Questionnaire, Muscle Enzyme, and EGA. A total improvement score (range 0 to 100; higher the score, better the condition), 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, respectively on the TIS. Least squares (LS) means were estimated using a mixed model repeated measures (MMRM) including treatment, visit, the interaction between treatment and visit, region, and baseline MMT-8 (<=142 points vs >142 points) as fixed effects, participant as a random effect.
At Week 25
Mean Changes From Baseline in MMT-8
Time Frame: From Baseline to Week 25
The MMT-8 was a set of 8 designated muscles which were tested bilaterally (potential score ranging from 0 to 150): 7 biaxial muscles with a potential score 0 to 140 and 1 axial (neck flexors) with a potential score of 0 to 10. Improvement is documented with an increase in score. LS means were estimated using a MMRM including treatment, visit, the interaction between treatment and visit, and region as fixed effects, baseline MMT-8 as a continuous covariate and participant as a random effect.
From Baseline to Week 25
Mean Changes From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Total Activity Score (CDASI-A)
Time Frame: From Baseline to Week 25
The CDASI in its modified version 2 (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. LS means were estimated using a MMRM including treatment, visit, the interaction between treatment and visit, region, and baseline MMT-8 (<=142 points vs >142 points) as fixed effects, baseline CDASI-A as a continuous covariate, and participants as a random effect.
From Baseline to Week 25
Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%
Time Frame: At Week 25
Reduction in corticosteroid dose.
At Week 25
Period 1: Mean TIS at Each Visit
Time Frame: At Week 5, 9, 13, 17, 21, and 25
The TIS was a sum response criterion which incorporates 6 weighted IMACS CSMs including Physician and PGA, MMT-8, Health Assessment Questionnaire, Muscle Enzyme, and EGA. 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.
At Week 5, 9, 13, 17, 21, and 25
Period 2: Mean TIS at Each Visit
Time Frame: Week 25, 29, 33, 37, 41, 45, 49, and 53
The TIS was a sum response criterion which incorporates 6 weighted IMACS CSMs including Physician and PGA, MMT-8, Health Assessment Questionnaire, Muscle Enzyme, and EGA. 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 25, 29, 33, 37, 41, 45, 49, and 53
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Time Frame: At Week 5, 9, 13, 17, 21, and 25
Participants were considered and reported in more than one category (TIS >= 20, >= 40 and >= 60 Points).
At Week 5, 9, 13, 17, 21, and 25
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Time Frame: Week 25, 29, 33, 37, 41, 45, 49, and 53
Participants were considered and reported in more than one category (TIS >= 20, >= 40 and >= 60 Points).
Week 25, 29, 33, 37, 41, 45, 49, and 53
Period 1: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points on the TIS
Time Frame: Up to Week 25
The observation was censored if no improvement was observed before the intake of rescue/increased doses of oral corticosteroids in SP1 or before the end of the period.
Up to Week 25
Period 1 and 2: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points Improvement on the TIS
Time Frame: Up to Week 53
The observation was censored if no improvement was observed before the intake of rescue/increased doses of oral corticosteroids in SP1 or before the end of the period.
Up to Week 53
Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI
Time Frame: From Baseline to Week 25
Individual CSMs included following: Myositis Disease Activity Assessment Tool (MDAAT) Physician global disease activity (PGDA), PGA assessment, MMT-8, health assessment questionnaire-disability index (HAQ-DI), and MDAAT-EGA. Higher values were associated with a better state of health for the MMT-8 (range 0 -150) assessment, while lower values were associated with a better state of health for: MDAAT-PGDA (range 0 -100), PGA (range 0-100), HAQ-DI (range 0-3), MDAAT-EGA (range 0 -100), and CDASI-A (range 0-100).
From Baseline to Week 25
Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI
Time Frame: From Week 25 to Week 53
Individual CSMs included following: MDAAT-PGDA, PGA assessment, MMT-8, HAQ-DI, and MDAAT extramacular global assessment. Higher values were associated with a better state of health for the MMT-8 (range 0 -150) assessment, while lower values were associated with a better state of health for: MDAAT-PGDA (range 0 -100), PGA (range 0-100), HAQ-DI (range 0-3), MDAAT-EGA (range 0 -100), and CDASI-A (range 0-100).
From Week 25 to Week 53
Period 1: Number of Participants Meeting Definition of Worsening (DOW) at Least Once, Twice, or > Twice
Time Frame: Up to Week 25
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment Visual Analog Scale (VAS) worsening >= 2 cm* and MMT-8 worsening >= absolute 10%, or EGA worsening >= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by >= absolute 20%. (*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)
Up to Week 25
Period 1: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice
Time Frame: Up to Week 25
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening >= 2 cm* and MMT-8 worsening >= absolute 10%, or EGA worsening >= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by >= absolute 20%. (*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)
Up to Week 25
Period 2: Number of Participants Meeting DOW at Least Once, Twice, or > Twice
Time Frame: From Week 25 up to Week 53
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening >= 2 cm* and MMT-8 worsening >= absolute 10%, or EGA worsening >= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by >= absolute 20%. (*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)
From Week 25 up to Week 53
Period 2: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice
Time Frame: From Week 25 up to Week 53
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening >= 2 cm* and MMT-8 worsening >= absolute 10%, or EGA worsening >= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by >= absolute 20%. (*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)
From Week 25 up to Week 53
Time to Meeting DOW for the First Time
Time Frame: Up to Week 53
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening >= 2 cm* and MMT-8 worsening >= absolute 10%, or EGA worsening >= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by >= absolute 20%. (*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) The observation was censored if no DOW was observed before the intake of rescue treatment or before the end of the period.
Up to Week 53
Number of Participants Meeting DOW and Receiving Rescue Steroid Treatment
Time Frame: Up to Week 25
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening >= 2 cm* and MMT-8 worsening >= absolute 10%, or EGA worsening >= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by >= absolute 20%. (*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) The Number of participants meeting DOW and who received rescue steroid treatment are reported here.
Up to Week 25
Percentage of Participants Meeting DOW and Receiving Rescue Steroid Treatment
Time Frame: Up to Week 25
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening >= 2 cm* and MMT-8 worsening >= absolute 10%, or EGA worsening >= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by >= absolute 20%. (*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) The percentage of participants meeting DOW and who received rescue steroid treatment are reported here.
Up to Week 25
Number of Participants Who Start Oral Corticosteroid Dose Taper
Time Frame: Up to Week 25
Up to Week 25
Percentage of Participants Who Start Oral Corticosteroid Dose Taper
Time Frame: Up to Week 25
Up to Week 25
Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Time Frame: Up to Week 25 and 52
Up to Week 25 and 52
Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Time Frame: Up to Week 25 and 52
Up to Week 25 and 52
Percentage of Participants Receiving Rescue Corticosteroid Treatment
Time Frame: Up to Week 25
Up to Week 25
Percentage of Participants Whose Rescue Corticosteroid Treatment is Tapered
Time Frame: Up to Week 25
Up to Week 25
Time to First Intake of Rescue Corticosteroid Treatment
Time Frame: Up to Week 25
The observation was censored if no Rescue was observed before the last day of the last week with IMP intake or before the end of the period.
Up to Week 25
Number of Participants 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: From Baseline to Week 13 and 25
EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from "no problems" to "unable to" walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants 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 are reported in this outcome measure.
From Baseline to Week 13 and 25
Percentage of Participants 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: From Baseline to Week 13 and 25
EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from "no problems" to "unable to" walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants 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 are reported in this outcome measure.
From Baseline to Week 13 and 25
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Time Frame: From Week 25 to 41 and 53
EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from "no problems" to "unable to" walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having no reduction, 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 are reported in this outcome measure.
From Week 25 to 41 and 53
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Time Frame: From Week 25 to 41 and 53
EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from "no problems" to "unable to" walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having no reduction, 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 are reported in this outcome measure.
From Week 25 to 41 and 53
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs
Time Frame: Up to 5 years
Up to 5 years
Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk
Time Frame: Up to 5 years
Up to 5 years
Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CSL Behring

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, CSL Behring

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IgPro20_3007
  • 2018-003171-35 (EudraCT Number)
  • 2023-508293-28-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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