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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: ClinicalTrials.gov
Last refreshed on: 25 January 2021
Main ID:  NCT04137224
Date of registration: 21/10/2019
Prospective Registration: Yes
Primary sponsor: CSL Behring
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)
Date of first enrolment: September 19, 2019
Target sample size: 26
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04137224
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Australia France Germany Italy Poland United Kingdom
Contacts
Name:     Trial Registration Coordinator
Address: 
Telephone: 610-878-4000
Email: clinicaltrials@cslbehring.com
Affiliation: 
Name:     Study Director
Address: 
Telephone:
Email:
Affiliation:  CSL Behring
Key inclusion & exclusion criteria

Inclusion Criteria:

- Age = 18 years (male or female) at time of providing written informed consent

- 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).

- Modified Rodnan Skin Score (mRSS) = 15 and = 45 at screening

- Disease duration = 5 years defined as the time from the first non-Raynaud's phenomenon
manifestation

- Capable of providing written informed consent and willing and able to adhere to all
protocol requirements

Exclusion Criteria:

- 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

- Subject has mRSS > 2 at the potential subcutaneous (SC) infusion sites

- 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)

- Subject has clinical signs and symptoms of skin irritation (eg, pruritus, burning,
erythema) or hypo/ hyperpigmentation (eg, scars, tattoos) at the potential SC infusion
sites

- Significant pulmonary arterial hypertension as documented by mean pulmonary arterial
pressure > 30 mmHg on right heart catheterization requiring SC or IV prostacyclin or
use of dual oral therapies

- Forced vital capacity < 50% predicted or a diffusing capacity of the lung for carbon
dioxide (DLCO) = 40% predicted (corrected for hemoglobin)

- A female who is pregnant, breastfeeding, or is a woman of childbearing potential who
does not agree to use acceptable methods of contraception; a male who does agree to
use acceptable methods of contraception.

- Evidence of chronic kidney disease with an estimated glomerular filtration rate (eGFR)
< 45 mL/min/1.73m2 or if subject is receiving dialysis. Subjects with current
confirmed diagnosis of diabetes mellitus requiring medication with an eGFR < 90
ml/min/1.73m2



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Diffuse Cutaneous Systemic Sclerosis
Intervention(s)
Biological: IgPro10
Biological: IgPro20
Primary Outcome(s)
Duration of ISRs for IgPro20 [Time Frame: Up to 16 weeks]
Number and percentage of subjects with adverse events of special interest (AESIs) for IgPro20 [Time Frame: Up to 16 weeks]
Number and percentage of subjects with seriouis adverse events (SAEs) for IgPro20 [Time Frame: Up to 16 weeks]
Number and percentage of subjects with treatment emergent adverse events (TEAEs) for IgPro20 [Time Frame: Up to 16 weeks]
Number of patients with AEs categorized as infusion site reactions (ISRs) for IgPro20 [Time Frame: Up to 16 weeks]
Number of subjects with adverse events (AEs) for IgPro20 [Time Frame: Up to 16 weeks]
Onset of ISRs for IgPro20 [Time Frame: Up to 16 weeks]
Percentage of patients with AEs categorized as ISRs for IgPro20 [Time Frame: Up to 16 weeks]
Percentage of subjects with AEs for IgPro20 [Time Frame: Up to 16 weeks]
Rate of ISRs per infusion for IgPro20 [Time Frame: Up to 16 weeks]
Rate of ISRs per subject for IgPro20 [Time Frame: Up to 16 weeks]
Secondary Outcome(s)
Area under the concentration curve to the end of the dosing period (AUC0-tau) for IgPro10 [Time Frame: Up to 672 hours after first infusion]
Area under the concentration curve to the end of the dosing period (AUC0-tau) for IgPro20 [Time Frame: Up to 240 hours after first infusion]
Area under the concentration curve up to the last measurable concentration (AUC0-last) for IgPro10 [Time Frame: Up to 672 hours after first infusion]
Area under the concentration curve up to the last measurable concentration (AUC0-last) for IgPro20 [Time Frame: Up to 240 hours after first infusion]
IgPro20 relative bioavailability (%F) [Time Frame: Up to 16 weeks]
Maximum plasma drug concentration (Cmax) for IgPro10 [Time Frame: Up to 672 hours after first infusion]
Maximum plasma drug concentration (Cmax) for IgPro20 [Time Frame: Up to 240 hours after first infusion]
Minimum plasma drug concentration (Ctrough) for IgPro10 [Time Frame: Prior to infusion]
Minimum plasma drug concentration (Ctrough) for IgPro20 [Time Frame: Prior to infusion]
Number and percentage of subjects with adverse events of special interest (AESIs) for IgPro10 [Time Frame: Up to 16 weeks]
Number and percentage of subjects with AEs categorized as ISRs for IgPro10 [Time Frame: Up to 16 weeks]
Number and percentage of subjects with AEs for IgPro10 [Time Frame: Up to 16 weeks]
Number and percentage of subjects with seriouis adverse events (SAEs) for IgPro10 [Time Frame: Up to 16 weeks]
Number and percentage of subjects with treatment emergent adverse events (TEAEs) for IgPro10 [Time Frame: Up to 16 weeks]
Secondary ID(s)
2018-003149-41
IgPro20_2001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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