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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 10 December 2019
Main ID:  EUCTR2018-003171-35-FR
Date of registration: 11/09/2019
Prospective Registration: Yes
Primary sponsor: CSL Behring LLC
Public title: A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)
Scientific title: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM)
Date of first enrolment: 24/09/2019
Target sample size: 126
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003171-35
Study type:  Interventional clinical trial of medicinal product
Study design: 
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Argentina Australia Canada European Union France Japan Mexico Russian Federation
Switzerland Ukraine United Kingdom United States
Contacts
Name: Trial Registration Coordinator   
Address:  Emil-von-Behring-Strasse 76 35041 Marburg Germany
Telephone: +1610878 4000
Email: clinicaltrials@cslbehring.com
Affiliation:  CSL Behring GmbH
Name: Trial Registration Coordinator   
Address:  Emil-von-Behring-Strasse 76 35041 Marburg Germany
Telephone: +1610878 4000
Email: clinicaltrials@cslbehring.com
Affiliation:  CSL Behring GmbH
Key inclusion & exclusion criteria
Inclusion criteria:
male or female subjects = 18 years of age with diagnosis of at least probable (idiopathic inflammatory myopathies) IIM per 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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Dermatomyositis
MedDRA version: 20.0 Level: LLT Classification code 10001403 Term: Adult dermatomyositis System Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Intervention(s)

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
Other descriptive name: Hizentra
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)
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.
Primary end point(s): Responder rate
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, and the long-term safety and efficacy of IgPro20
Timepoint(s) of evaluation of this end point: Weeks 17, 21, and 25
Secondary Outcome(s)

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 throughout the study,
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 the study participation,
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 corticosteroid dose by = 25%, = 50%, = 75%,
26. Percentage of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75%,
27. Percentage of subjects receiving rescue corticosteroid treatment,
28. Percentage of subjects whose rescue corticosteroid treatment is tapered,
29. Time to first intake of rescue corticosteroid treatment,
30. 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 EQ-5D-5L,
31. 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,
32. 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,
33. 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,
34. Percentage of subjects with Treatment Emergent Adverse Events (TEAEs),
35. Percentage of subjects with related TEAEs,
36. Percentage of subjects with serious TEAEs,
37. Rate of TEAEs per infusion,
38. Rate of TEAEs per infusion, by severity,
39. Rate of related TEAEs per infusion,
40. Rate of serious TEAEs per infusion.

Timepoint(s) of evaluation of this end point: 1. Up to Week 25,
2. Up to Week 25,
3. Up to Week 25,
4. Up to Week 25,
5. Up to Week 25,
6. Up to Week 25,
7. Up to Week 25,
8. Up to Week 25,
9. Up to Week 25,
10. Baseline up to Week 53,
11. Up to Week 53,
12. Up to Week 53,
13. Up to Week 53,
14. Up to Week 25,
15. Week 25 to Week 53,
16. Week 9 up to Week 25,
17. Week 9 up to Week 25,
18. Week 9 up to Week 25,
19. Week 9 up to Week 25,
20. Week 9 up to Week 25,
21. Up to Week 25,
22. Up to Week 25,
23. Up to Week 25,
24. Up to Week 53,
25. Up to Week 25,
26. Up to Week 53,
27. Week 9 up to Week 25,
28. Week 9 up to Week 25,
29. Week 9 up to Week 25,
30. Up to Week 25,
31. Up to Week 25,
32. Up to Week 53,
33. Week 25 up to Week 53,
34-40. Up to Week 56.
Secondary ID(s)
IgPro20_3007
Source(s) of Monetary Support
CSL Behring LLC, 1020 First Avenue, King of Prussia, PA 19406
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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