CSL312 for Idiopathic Pulmonary Fibrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Idiopathic Pulmonary FibrosisCSL312 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will assess if CSL312 is a safe and effective treatment for idiopathic pulmonary fibrosis.

Eligible Conditions
  • Idiopathic Pulmonary Fibrosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

8 Primary · 9 Secondary · Reporting Duration: Up to 22 weeks

Up to 14 weeks
Area under the plasma concentration-time curve after the first dose interval (AUC0-tau) (last SC dosing interval only) of CSL312
Maximum plasma concentration (Cmax) (last SC dosing interval only) of CSL312
Mean change from Baseline in FXIIa-mediated kallikrein activity of CSL312
Mean percentage of Baseline in FXIIa-mediated kallikrein activity of CSL312
Number of participants with treatment-emergent CSL312 induced antidrug antibodies (ADAs)
Number of participants with treatment-emergent clinically significant abnormalities in laboratory assessments that are reported as adverse events (AEs) for CSL312 or placebo
Percent of participants with CSL312 induced ADAs
Percent of participants with treatment-emergent clinically significant abnormalities in laboratory assessments that are reported as adverse events (AEs) for CSL312 or placebo
Time to maximum plasma concentration (Tmax) (last SC dosing interval only) of CSL312
Trough plasma concentration (Ctrough) after subcutaneous (SC) administration of CSL312
Up to 22 weeks
Number of participants with treatment-emergent adverse events of special interest (AESIs) for CSL312 or placebo
Number of participants with treatment-emergent serious adverse events (SAEs) for CSL312 or placebo
Percent of participants with AESIs for CSL312 or placebo
Percent of participants with SAEs for CSL312 or placebo
Up to 8 days
Cmax after IV administration of CSL312
Ctrough after intravenous (IV) administration of CSL312
Tmax after IV administration of CSL312

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

CSL312
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

80 Total Participants · 2 Treatment Groups

Primary Treatment: CSL312 · Has Placebo Group · Phase 2

CSL312
Drug
Experimental Group · 1 Intervention: CSL312 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Garadacimab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 22 weeks

Who is running the clinical trial?

CSL BehringLead Sponsor
186 Previous Clinical Trials
407,679 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring
1,071 Previous Clinical Trials
475,522 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male or female and are 40 years of age or older.
You have a documented diagnosis of IPF.