Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)

NCT ID: NCT04137224

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-19
• Study Completion Date: 2022-05-17

Brief Summary

This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in participants 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 participants with dcSSc. Safety, tolerability, and pharmacokinetics of IgPro10 will also be evaluated.

Conditions

Diffuse Cutaneous Systemic Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence A (IgPro20/IgPro10)

Participants received IgPro20 of a total dose of 0.5 grams per kilogram (g/kg) over 2 sessions per week as a subcutaneous (SC) injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an intravenous (IV) infusion for up to 16 weeks in Treatment Period 2.

Group Type: EXPERIMENTAL

IgPro20

Intervention Type: BIOLOGICAL

Human normal immunoglobulin for subcutaneous administration

IgPro10

Intervention Type: BIOLOGICAL

Human normal immunoglobulin for intravenous administration

Sequence B (IgPro10/IgPro20)

Participants received IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.

Group Type: EXPERIMENTAL

IgPro20

Intervention Type: BIOLOGICAL

Human normal immunoglobulin for subcutaneous administration

IgPro10

Intervention Type: BIOLOGICAL

Human normal immunoglobulin for intravenous administration

Interventions

IgPro20

Human normal immunoglobulin for subcutaneous administration

Intervention Type: BIOLOGICAL

IgPro10

Human normal immunoglobulin for intravenous administration

Intervention Type: BIOLOGICAL

Other Intervention Names

Hizentra; Privigen

Eligibility 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: Participants with fibromyalgia, secondary Sjogren's syndrome, and scleroderma-associated myopathy at screening are not excluded
• Participants has mRSS > 2 at the potential subcutaneous (SC) injection 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)
• Participants has clinical signs and symptoms of skin irritation (eg, pruritus, burning, erythema) or hypo/ hyperpigmentation (eg, scars, tattoos) at the potential SC injection 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 participants are receiving dialysis. Participants with current confirmed diagnosis of diabetes mellitus requiring medication with an eGFR < 90 ml/min/1.73m2

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

CSL Behring

Locations

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Charité Universitätsmedizin Berlin

Berlin, , Germany

Uniklinik Köln, innere Medizin

Cologne, , Germany

ASST Spedali Civili di Brescia

Brescia, , Italy

Azienda Ospedaliera Gaetano Pini

Milan, , Italy

Uniwersytecki Szpital Kliniczny W Bialymstoku

Bialystok, , Poland

Szpital Kliniczny Jezus

Warsaw, , Poland

Narodowy Instytut Geriatrii

Warsaw, , Poland

The Royal Free Hospital

London, , United Kingdom

Countries

Australia; Germany; Italy; Poland; United Kingdom

References

Denton CP, Kowal-Bielecka O, Proudman SM, Olesinska M, Worm M, Del Papa N, Matucci-Cerinic M, Radewonuk J, Jochems J, Panaite A, Shebl A, Krupa A, Allanore Y, Hofmann JH, Gasior MJ. A phase 2 randomized trial of safety and pharmacokinetics of IgPro20 and IgPro10 in patients with diffuse cutaneous systemic sclerosis. Rheumatology (Oxford). 2025 Jun 1;64(6):3657-3666. doi: 10.1093/rheumatology/keaf066.

Reference Type: DERIVED

PMID: 39909490 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-003149-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IgPro20_2001

Identifier Type: -

Identifier Source: org_study_id