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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 April 2024
• Main ID: NCT04044690
• Date of registration: 01/08/2019
• Prospective Registration: Yes
• Primary sponsor: CSL Behring
• Public title: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) RECLAIIM
• Scientific title: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study
• Date of first enrolment: October 21, 2019
• Target sample size: 126
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04044690
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Study Director
• Affiliation: CSL Behring

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dermatomyositis

Intervention(s)

Drug: human immunoglobulin G

Drug: Placebo

Primary Outcome(s)

Responder Rate [Time Frame: Weeks 17, 21, and 25]

Secondary Outcome(s)

Mean change difference (IgPro20 minus placebo) in CDASI [Time Frame: Up to week 25]

Percentage of subjects meeting DOW at least once, twice, or > twice [Time Frame: Baseline up to Week 53]

Percentage of subjects who are able to reduce the oral corticosteroid dose by = 25% [Time Frame: Up to Week 25]

Percentage of subjects who start oral corticosteroid dose taper [Time Frame: Baseline up to Week 53]

Percentage of subjects whose rescue steroid treatment is tapered [Time Frame: Baseline up to Week 25]

Percentage of subjects with serious TEAEs [Time Frame: Up to 8 years]

Number of subjects who start oral corticosteroid dose taper [Time Frame: Baseline up to Week 53]

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 [Time Frame: Baseline up to Week 53]

Percentage of subjects with Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to 8 years]

Rate of related TEAEs per days with infusion [Time Frame: Up to 8 years]

Rate of TEAEs per days with infusion, by severity [Time Frame: Up to 8 years]

Mean change difference (IgPro20 minus placebo) in MMT-8 [Time Frame: Up to week 25]

Mean changes from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score [Time Frame: Up to week 25]

Mean Total Improvement Score (TIS) [Time Frame: Up to Week 25]

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

Time to first intake of rescue corticosteroid treatment [Time Frame: Baseline up to Week 25]

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 [Time Frame: From Week 25 up to week 53]

Percentage of subjects with related TEAEs [Time Frame: Up to 8 years]

Rate of serious TEAEs per days with infusion [Time Frame: Up to 8 years]

Time to meeting DOW for the first time [Time Frame: Baseline up to Week 53]

Mean changes in individual CSMs (except muscle enzymes) and CDASI [Time Frame: From week 29 to week 53]

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 [Time Frame: From Week 25 up to week 53]

Number of subjects meeting DOW and receiving rescue steroid treatment [Time Frame: Baseline up to Week 53]

Number of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75% [Time Frame: Baseline up to Week 53]

Percentage of subjects achieving TIS = 20 points at the end of study period 2 [Time Frame: Up to week 53]

Percentage of subjects receiving rescue steroid treatment [Time Frame: Baseline up to Week 25]

Time to first achieving TIS = 20, = 40, and = 60 points on the TIS [Time Frame: Week 5 up to Week 53]

Mean difference (IgPro20 minus placebo) in TIS [Time Frame: Up to week 25]

Mean TIS [Time Frame: Week 5 up to Week 53]

Percentage of subjects meeting DOW and receiving rescue steroid treatment [Time Frame: Baseline up to Week 53]

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) [Time Frame: Baseline up to Week 53]

Number of subjects who are able to reduce the oral corticosteroid dose by = 25% [Time Frame: Up to Week 25]

Number of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75% [Time Frame: Baseline up to Week 25]

Rate of TEAEs per days with infusion [Time Frame: Up to 8 years]

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

Mean changes from Baseline in Manual Muscle Testing (MMT-8) [Time Frame: Up to week 25]

Percentage of subjects achieving TIS = 20, = 40, and = 60 points [Time Frame: Week 5 up to Week 53]

Percentage of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75% [Time Frame: Baseline up to Week 25]

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

Secondary ID(s)

IgPro20_3007

2018-003171-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors