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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04137224




Registration number
NCT04137224
Ethics application status
Date submitted
21/10/2019
Date registered
23/10/2019
Date last updated
8/07/2020

Titles & IDs
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)
Secondary ID [1] 0 0
2018-003149-41
Secondary ID [2] 0 0
IgPro20_2001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Cutaneous Systemic Sclerosis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - IgPro20
Other interventions - IgPro10

Experimental: IgPro20 - 20% liquid formulation of human immunoglobulin for subcutaneous use

Experimental: IgPro10 - 10% liquid formulation of human immunoglobulin for intravenous use


Other interventions: IgPro20
Human normal immunoglobulin for subcutaneous administration

Other interventions: IgPro10
Human normal immunoglobulin for intravenous administration

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with adverse events (AEs) for IgPro20
Timepoint [1] 0 0
Up to 16 weeks
Primary outcome [2] 0 0
Percentage of subjects with AEs for IgPro20
Timepoint [2] 0 0
Up to 16 weeks
Primary outcome [3] 0 0
Number and percentage of subjects with treatment emergent adverse events (TEAEs) for IgPro20
Timepoint [3] 0 0
Up to 16 weeks
Primary outcome [4] 0 0
Number and percentage of subjects with seriouis adverse events (SAEs) for IgPro20
Timepoint [4] 0 0
Up to 16 weeks
Primary outcome [5] 0 0
Number and percentage of subjects with adverse events of special interest (AESIs) for IgPro20
Timepoint [5] 0 0
Up to 16 weeks
Primary outcome [6] 0 0
Number of patients with AEs categorized as infusion site reactions (ISRs) for IgPro20
Timepoint [6] 0 0
Up to 16 weeks
Primary outcome [7] 0 0
Percentage of patients with AEs categorized as ISRs for IgPro20
Timepoint [7] 0 0
Up to 16 weeks
Primary outcome [8] 0 0
Rate of ISRs per subject for IgPro20
Timepoint [8] 0 0
Up to 16 weeks
Primary outcome [9] 0 0
Rate of ISRs per infusion for IgPro20
Timepoint [9] 0 0
Up to 16 weeks
Primary outcome [10] 0 0
Onset of ISRs for IgPro20
Timepoint [10] 0 0
Up to 16 weeks
Primary outcome [11] 0 0
Duration of ISRs for IgPro20
Timepoint [11] 0 0
Up to 16 weeks
Secondary outcome [1] 0 0
IgPro20 relative bioavailability (%F)
Timepoint [1] 0 0
Up to 16 weeks
Secondary outcome [2] 0 0
Area under the concentration curve to the end of the dosing period (AUC0-tau) for IgPro20
Timepoint [2] 0 0
Up to 240 hours after first infusion
Secondary outcome [3] 0 0
Area under the concentration curve up to the last measurable concentration (AUC0-last) for IgPro20
Timepoint [3] 0 0
Up to 240 hours after first infusion
Secondary outcome [4] 0 0
Maximum plasma drug concentration (Cmax) for IgPro20
Timepoint [4] 0 0
Up to 240 hours after first infusion
Secondary outcome [5] 0 0
Minimum plasma drug concentration (Ctrough) for IgPro20
Timepoint [5] 0 0
Prior to infusion
Secondary outcome [6] 0 0
Area under the concentration curve to the end of the dosing period (AUC0-tau) for IgPro10
Timepoint [6] 0 0
Up to 672 hours after first infusion
Secondary outcome [7] 0 0
Area under the concentration curve up to the last measurable concentration (AUC0-last) for IgPro10
Timepoint [7] 0 0
Up to 672 hours after first infusion
Secondary outcome [8] 0 0
Maximum plasma drug concentration (Cmax) for IgPro10
Timepoint [8] 0 0
Up to 672 hours after first infusion
Secondary outcome [9] 0 0
Minimum plasma drug concentration (Ctrough) for IgPro10
Timepoint [9] 0 0
Prior to infusion
Secondary outcome [10] 0 0
Number and percentage of subjects with AEs for IgPro10
Timepoint [10] 0 0
Up to 16 weeks
Secondary outcome [11] 0 0
Number and percentage of subjects with treatment emergent adverse events (TEAEs) for IgPro10
Timepoint [11] 0 0
Up to 16 weeks
Secondary outcome [12] 0 0
Number and percentage of subjects with seriouis adverse events (SAEs) for IgPro10
Timepoint [12] 0 0
Up to 16 weeks
Secondary outcome [13] 0 0
Number and percentage of subjects with adverse events of special interest (AESIs) for IgPro10
Timepoint [13] 0 0
Up to 16 weeks
Secondary outcome [14] 0 0
Number and percentage of subjects with AEs categorized as ISRs for IgPro10
Timepoint [14] 0 0
Up to 16 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
St Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Paris
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Germany
State/province [3] 0 0
Köln
Country [4] 0 0
Germany
State/province [4] 0 0
Wuppertal
Country [5] 0 0
Italy
State/province [5] 0 0
AQ
Country [6] 0 0
Italy
State/province [6] 0 0
Ancona
Country [7] 0 0
Italy
State/province [7] 0 0
Brescia
Country [8] 0 0
Italy
State/province [8] 0 0
Firenze
Country [9] 0 0
Italy
State/province [9] 0 0
Milano
Country [10] 0 0
Poland
State/province [10] 0 0
Bialystok
Country [11] 0 0
Poland
State/province [11] 0 0
Warsaw
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CSL Behring
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a prospective, multicenter, randomized, open-label, crossover study to investigate
the safety, tolerability, and pharmacokinetics of IgPro20 in subjects with diffuse cutaneous
systemic sclerosis (dcSSc). The pharmacokinetic study aims to evaluate the relative
bioavailability of IgPro20, and characterize pharmacokinetics of IgPro20 and IgPro10,
respectively, in subjects with dcSSc. Safety, tolerability, and pharmacokinetics of IgPro10
will also be evaluated.
Trial website
https://clinicaltrials.gov/show/NCT04137224
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
CSL Behring
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Registration Coordinator
Address 0 0
Country 0 0
Phone 0 0
610-878-4000
Fax 0 0
Email 0 0
clinicaltrials@cslbehring.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04137224