A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003171-35-DE

Enrollment

126

Registered

2019-09-18

Start date

2020-01-20

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatomyositis MedDRA version: 20.0 Level: LLT Classification code 10001403 Term: Adult dermatomyositis System Organ Class: 100000004858

Interventions

Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 Pharmaceutical Form: Solution for injection INN or Proposed INN: human immunoglobulin G Current Sponsor code: IgPro20 Ot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: male or female subjects = 18 years of age with diagnosis of at least probable idiopathic inflammatory myopathies 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, and disease severity defined by Physician global 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 94 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32

Exclusion criteria

Exclusion criteria: Cancer-associated myositis, evidence of active malignant disease or malignancies diagnosed within the previous 5 years, Physician Global Damage = 3, or clinically relevant improvement between Screening Visit and Baseline

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to assess the efficacy of IgPro20 SC doses in comparison to placebo in adult subjects with DM, as measured by responder status based on the Total Improvement Score (TIS) assessments at Weeks 17, 21, and 25.;Secondary Objective: The secondary objectives of the study are to assess the efficacy, with additional clinical outcome measures, of IgPro20 in comparison to placebo, the safety of IgPro20 in comparison to placebo, safety and efficacy at Week 53, and safety after Week 53 to end of study participation of IgPro20.;Primary end point(s): Responder rate;Timepoint(s) of evaluation of this end point: Weeks 17, 21, and 25	—

Measure

Time frame

Main Objective: The primary objective of this study is to assess the efficacy of IgPro20 SC doses in comparison to placebo in adult subjects with DM, as measured by responder status based on the Total Improvement Score (TIS) assessments at Weeks 17, 21, and 25.;Secondary Objective: The secondary objectives of the study are to assess the efficacy, with additional clinical outcome measures, of IgPro20 in comparison to placebo, the safety of IgPro20 in comparison to placebo, safety and efficacy at Week 53, and safety after Week 53 to end of study participation of IgPro20.;Primary end point(s): Responder rate;Timepoint(s) of evaluation of this end point: Weeks 17, 21, and 25

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Secondary

Measure	Time frame
Secondary end point(s): 1. Mean Total Improvement Score (TIS), 2. Point estimates and 95% CI for mean difference (IgPro20 – placebo) in TIS, 3. Mean changes from Baseline in Manual Muscle Testing (MMT-8), 4. Point estimates and 95% CI for mean change difference (IgPro20 –placebo) in MMT-8, 5. Mean changes from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score, 6. Point estimates and 95% CI for mean change difference (IgPro20 – placebo), 7. Number of subjects who are able to reduce the oral corticosteroid dose by = 25% , 8. Percentage and 95% CI of subjects who are able to reduce the oral corticosteroid dose by = 25% 9. Point estimates and 95% CI for the odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by = 25% 10. Mean TIS, 11. Percentage of subjects achieving TIS = 20, = 40, and = 60 points, 12. Time to first achieving TIS = 20, = 40, and = 60 points on the TIS, 13. Percentage of subjects achieving TIS = 20 points at the end of study period 2, 14. Mean changes in individual CSMs (except muscle enzymes) and CDASI from Baseline, 15. Mean changes in individual CSMs except muscle enzymes and CDASI from Week 25, 16. Number of subjects meeting Definition of Worsening (DOW) at least once, twice, or > twice, 17. Percentage of subjects meeting DOW at least once, twice, or > twice, 18. Time to meeting DOW for the first time, 19. Number of subjects meeting DOW and receiving rescue corticosteroid treatment, 20. Percentage of subjects meeting DOW and receiving rescue corticosteroid treatment, 21. Number of subjects who start oral corticosteroid dose taper, 22. Percentage of subjects who start oral corticosteroid dose taper, 23. Number of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75%, 24. Number of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75%, 25. Percentage of subjects who are able to reduce the oral corticoste	—

Measure

Time frame

Secondary end point(s): 1. Mean Total Improvement Score (TIS), 2. Point estimates and 95% CI for mean difference (IgPro20 – placebo) in TIS, 3. Mean changes from Baseline in Manual Muscle Testing (MMT-8), 4. Point estimates and 95% CI for mean change difference (IgPro20 –placebo) in MMT-8, 5. Mean changes from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score, 6. Point estimates and 95% CI for mean change difference (IgPro20 – placebo), 7. Number of subjects who are able to reduce the oral corticosteroid dose by = 25% , 8. Percentage and 95% CI of subjects who are able to reduce the oral corticosteroid dose by = 25% 9. Point estimates and 95% CI for the odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by = 25% 10. Mean TIS, 11. Percentage of subjects achieving TIS = 20, = 40, and = 60 points, 12. Time to first achieving TIS = 20, = 40, and = 60 points on the TIS, 13. Percentage of subjects achieving TIS = 20 points at the end of study period 2, 14. Mean changes in individual CSMs (except muscle enzymes) and CDASI from Baseline, 15. Mean changes in individual CSMs except muscle enzymes and CDASI from Week 25, 16. Number of subjects meeting Definition of Worsening (DOW) at least once, twice, or > twice, 17. Percentage of subjects meeting DOW at least once, twice, or > twice, 18. Time to meeting DOW for the first time, 19. Number of subjects meeting DOW and receiving rescue corticosteroid treatment, 20. Percentage of subjects meeting DOW and receiving rescue corticosteroid treatment, 21. Number of subjects who start oral corticosteroid dose taper, 22. Percentage of subjects who start oral corticosteroid dose taper, 23. Number of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75%, 24. Number of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75%, 25. Percentage of subjects who are able to reduce the oral corticoste

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Countries

Argentina, Australia, Belgium, European Union, France, Germany, Hungary, Italy, Japan, Mexico, Russian Federation, Switzerland, Ukraine, United Kingdom, United States

Contacts

Public ContactTrial Registration Coordinator

CSL Behring GmbH

clinicaltrials@cslbehring.com+1610878 4000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026