World Health Organization site
Skip Navigation Links

Main
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: 25 November 2019
Main ID:  EUCTR2018-003149-41-FR
Date of registration: 27/03/2019
Prospective Registration: Yes
Primary sponsor: CSL Behring GmbH
Public title: Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc).
Scientific title: A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a
Date of first enrolment: 24/05/2019
Target sample size: 26
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003149-41
Study type:  Interventional clinical trial of medicinal product
Study design: 
Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Two treatment periods: IgPro10 and then IgPro20 or vice versa
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Australia France Germany Italy Poland United Kingdom
Contacts
Name: Trial Registration Coordinator   
Address:  1020 First Ave, 19406 King of Prussia,PA United States
Telephone: 0016108784000
Email: clinicaltrials@cslbehring.com
Affiliation:  CSLB
Name: Trial Registration Coordinator   
Address:  1020 First Ave, 19406 King of Prussia,PA United States
Telephone: 0016108784000
Email: clinicaltrials@cslbehring.com
Affiliation:  CSLB
Key inclusion & exclusion criteria
Inclusion criteria:
1. Age = 18 years (male or female) at time of providing written informed consent
2. Documented diagnosis of systemic sclerosis (scleroderma) according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria 2013 (diffuse cutaneous form of SSc).
3. mRSS = 15 and = 45 at screening
4. Disease duration = 5 years defined as the time from the first non-Raynaud’s phenomenon manifestation
5. A female who is not pregnant, not breastfeeding, and either is not a woman of childbearing potential or is a woman of childbearing potential who agrees to use acceptable methods of contraception
6. Capable of providing written informed consent and willing and able to adhere to all protocol requirements
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 26
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Primary rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, dermatomyositis, as determined by the investigator. Note: Subjects with fibromyalgia, secondary Sjogren’s syndrome, and scleroderma-associated myopathy at screening are not excluded
2. Subject has mRSS > 2 at the potential subcutaneous (SC) infusion sites
3. History of skin condition precluding SC infusion, or clinical signs and symptoms of a chronic skin disease other than systemic sclerosis or skin manifestation of an allergic disease or other dermatological conditions that would interfere with trial assessments or compromise safety (eg, dermatitis, eczema, psoriasis)
4. Subject has clinical sign and symptoms of skin irritation (eg, pruritus, burning, erythema) or hypo/ hyperpigmentations (eg, scars, tattoos) at the potential SC infusion sites
5. Significant pulmonary arterial hypertension (PAH) as documented by mean pulmonary arterial pressure (PAP) > 30 mmHg on right heart catheterization requiring SC or IV prostacyclin or use of dual oral therapies
6. FVC < 50% predicted or a diffusing capacity of the lung for carbon dioxide (DLCO) = 40% predicted (corrected for hemoglobin) at screening




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 20.0 Level: LLT Classification code 10012977 Term: Diffuse systemic sclerosis System Organ Class: 100000004859
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: Hizentra
Product Name: Human normal immunoglobulin for subcutaneous administration
Product Code: IgPro20
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Human normal immunoglobulin
Current Sponsor code: IgPro20
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-

Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous administration
Product Code: IgPro10
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human normal immunoglobulin
Current Sponsor code: IgPro10
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): - Number and percentage of subjects with adverse events (AEs) for IgPro20
- Number and percentage of patients with AEs categorized as injection site reactions (ISRs) for IgPro20
- Rate of ISRs per subject for IgPro20
- Rate of ISRs per infusion for IgPro10
- Onset of ISRs for IgPro20
- Duration of ISRs for IgPro20

Secondary Objective: The secondary objectives of the study are to evaluate:
• Relative bioavailability of IgPro20
• Pharmacokinetics of IgPro20
• Pharmacokinetics of IgPro10
• Safety of IgPro10
Main Objective: The primary objective of the study is to evaluate the safety of IgPro20 in adults with dcSSc.
Timepoint(s) of evaluation of this end point: Up to 16 weeks
Secondary Outcome(s)

Secondary end point(s): - IgPro20 relative bioavailability (%F)
- Area under the concentration curve to the end of the dosing period (AUC0-tau) for IgPro20
- Area under the concentration curve up to the last measurable concentration (AUC0-last) for IgPro20
- Maximum [peak] plasma drug concentration (Cmax) for IgPro20
- Minimum plasma drug concentration (Ctrough) for IgPro20
-Area under the concentration curve to the end of the dosing period (AUC0-tau) for IgPro10
-Area under the concentration curve up to the last measurable concentration (AUC0-last) for IgPro10
-Maximum [peak] plasma drug concentration (Cmax) for IgPro10
-Minimum plasma drug concentration (Ctrough) for IgPro10
-Number and percentage of subjects with adverse events (AEs) for IgPro10
-Number and percentage of subjects with AEs categorized as ISRs for IgPro10

Timepoint(s) of evaluation of this end point: - Up to 16 weeks
- Up to 240 hours after first infusion
- Up to 240 hours after first infusion
- Up to 240 hours after first infusion
- Prior to infusion
- Up to 672 hours after first infusion
- Up to 672 hours after first infusion
- Up to 672 hours after first infusion
- Prior to infusion
- Up to 16 weeks
- Up to 16 weeks
Secondary ID(s)
2018-003149-41-DE
IgPro20_2001
Source(s) of Monetary Support
CSL Behring GmbH
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history