Phase 2
N=27
Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
Diffuse Cutaneous Systemic Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT04137224 ↗Enrolled (actual)
27
Serious AEs
13.2%
Results posted
Feb 2024
Primary outcome: Primary: Number of Participants With at Least One Adverse Event (AE) for IgPro20 — 9; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IgPro20 (Biological); IgPro10 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CSL Behring
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least One Adverse Event (AE) for IgPro20 |
9; 9 | — |
| PRIMARY Percentage of Participants With at Least One AE for IgPro20 |
69.2; 69.2 | — |
| PRIMARY Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) for IgPro20 |
9; 9 | — |
| PRIMARY Percentage of Participants With at Least One TEAE for IgPro20 |
69.2; 69.2 | — |
| PRIMARY Number of Participants With at Least One Serious Adverse Event (SAE) for IgPro20 |
2; 3 | — |
| PRIMARY Percentage of Participants With at Least One SAE for IgPro20 |
15.4; 23.1 | — |
| PRIMARY Number of Participants With at Least One Adverse Event of Special Interest (AESI) for IgPro20 |
0; 1 | — |
| PRIMARY Percentage of Participants With at Least One AESI for IgPro20 |
0; 7.7 | — |
| PRIMARY Number of Participants With AEs Categorized as Infusion Site Reactions (ISRs) for IgPro20 |
2; 3 | — |
| PRIMARY Percentage of Participants With AEs Categorized as ISRs for IgPro20 |
15.4; 23.1 | — |
| PRIMARY Rate of ISRs Per Infusion for IgPro20 |
0.0057; 0.0360 | — |
| PRIMARY Time to Onset of ISRs for IgPro20 |
2.0; 15.0 | — |
| PRIMARY Duration of ISRs for IgPro20 |
162.0; 220.0 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormalities in Laboratory Tests for IgPro20 |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Vital Signs for IgPro20 |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters for IgPro20 |
0; 1 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormalities in Pulmonary Function Tests (PFTs) for IgPro20 |
0; 0 | — |
| SECONDARY Relative Bioavailability (%F) of IgPro20 |
0.831; 0.698 | — |
| SECONDARY Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro20 |
3835.68; 3581.08 | — |
| SECONDARY Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro20 |
5361.61; 4898.02 | — |
| SECONDARY Maximum Plasma Drug Concentration (Cmax) for IgPro20 |
24.237; 23.203 | — |
| SECONDARY Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence A |
22.046; 21.950; 22.354; 21.814 | — |
| SECONDARY Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence B |
20.427; 21.603; 21.903; 20.497 | — |
| SECONDARY Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro10 |
16942.66; 17672.03 | — |
| SECONDARY Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro10 |
16520.48; 17349.72 | — |
| SECONDARY Maximum Plasma Drug Concentration (Cmax) for IgPro10 |
47.142; 44.996 | — |
| SECONDARY Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence A |
16.123; 17.497; 16.838 | — |
| SECONDARY Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence B |
17.104; 17.744; 17.113 | — |
| SECONDARY Number of Participants With at Least One AE for IgPro10 |
5; 8 | — |
| SECONDARY Percentage of Participants With at Least One AE for IgPro10 |
38.5; 57.1 | — |
| SECONDARY Number of Participants With at Least One TEAE for IgPro10 |
5; 8 | — |
| SECONDARY Percentage of Participants With at Least One TEAE for IgPro10 |
38.5; 57.1 | — |
| SECONDARY Number of Participants With at Least One SAE for IgPro10 |
1; 1 | — |
| SECONDARY Percentage of Participants With at Least One SAE for IgPro10 |
7.7; 7.1 | — |
| SECONDARY Number of Participants With at Least One AESI for IgPro10 |
0; 0 | — |
| SECONDARY Percentage of Participants With at Least One AESI for IgPro10 |
0; 0 | — |
| SECONDARY Number of Participants With AEs Categorized as ISRs for IgPro10 |
0; 0 | — |
| SECONDARY Percentage of Participants With AEs Categorized as ISRs for IgPro10 |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Laboratory Tests for IgPro10 |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Vital Signs for IgPro10 |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in ECG Parameters for IgPro10 |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in PFTs for IgPro10 |
0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04137224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.