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Monoclonal Antibodies

CSL312 for Idiopathic Pulmonary Fibrosis

Phase 2
Waitlist Available
Research Sponsored by CSL Behring
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 22 weeks
Awards & highlights

Study Summary

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

Who is the study for?
This trial is for men and women over 40 with a confirmed diagnosis of idiopathic pulmonary fibrosis (IPF). It's not suitable for those who've had significant heart disease, uncontrolled blood pressure, recent bleeding issues or clotting disorders.Check my eligibility
What is being tested?
The study is testing CSL312 against a placebo to see its effects on IPF. Participants will be randomly assigned to either the drug or placebo group in a double-blind manner, meaning neither they nor the researchers know who gets what.See study design
What are the potential side effects?
While specific side effects are not listed here, typical concerns may include reactions at the injection site, potential impact on organ function due to immune response modulation by CSL312, and general symptoms like fatigue or nausea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 22 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 22 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-emergent CSL312 induced antidrug antibodies (ADAs)
Number of participants with treatment-emergent adverse events of special interest (AESIs) for CSL312 or placebo
Number of participants with treatment-emergent clinically significant abnormalities in laboratory assessments that are reported as adverse events (AEs) for CSL312 or placebo
+5 more
Secondary outcome measures
Area under the plasma concentration-time curve after the first dose interval (AUC0-tau) (last SC dosing interval only) of CSL312
Cmax after IV administration of CSL312
Ctrough after intravenous (IV) administration of CSL312
+6 more

Side effects data

From 2022 Phase 3 trial • 64 Patients • NCT04656418
10%
Upper respiratory tract infection
8%
Headache
8%
Nasopharyngitis
5%
Visual impairment
5%
Diarrhoea
5%
Conjunctivitis
5%
Sinusitis
5%
Urinary tract infection
5%
Abdominal pain
5%
Back pain
5%
Oropharyngeal pain
5%
Gastrointestinal infection
3%
Pyrexia
3%
Injection site erythema
3%
Hereditary angioedema
100%
80%
60%
40%
20%
0%
Study treatment Arm
CSL312
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CSL312Experimental Treatment1 Intervention
Administered IV and SC
Group II: PlaceboPlacebo Group1 Intervention
Administered IV and SC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CSL312
2022
Completed Phase 3
~320

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor
194 Previous Clinical Trials
1,211,141 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring
1,201 Previous Clinical Trials
489,526 Total Patients Enrolled

Media Library

CSL312 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05130970 — Phase 2
Idiopathic Pulmonary Fibrosis Research Study Groups: CSL312, Placebo
Idiopathic Pulmonary Fibrosis Clinical Trial 2023: CSL312 Highlights & Side Effects. Trial Name: NCT05130970 — Phase 2
CSL312 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05130970 — Phase 2
Idiopathic Pulmonary Fibrosis Patient Testimony for trial: Trial Name: NCT05130970 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the geographical scope of this experiment?

"The present trial is accessible across 23 different sites, including Ocala, Los Angeles and Hannibal. It may be beneficial to pick the nearest location as it can reduce travelling expenses if you decide to join in on this experience."

Answered by AI

Are there any vacancies available to join this clinical experiment?

"Clinicaltrials.gov indicates that recruitment for this trial is proceeding as planned, with the initial post dated January 27th 2022 and a recent update on November 29th 2022."

Answered by AI

Is this a trailblazing clinical trial?

"Currently, CSL312 is being evaluated in two live studies across 19 countries and 52 cities. This drug was first trialled back in 2021 by CSL Behring with 171 participants as part of the Phase 3 approval process; since its inception, it has seen over 18 thousand trials."

Answered by AI

Has CSL312 been confirmed to meet the regulatory criteria of the FDA?

"Based on our assessment, CSL312 is rated a 2 for safety due to the limited clinical data available that has only demonstrated its protective qualities."

Answered by AI

How many individuals have been accepted into this experiment?

"Affirmative. According to clinicaltrials.gov, this particular medical trial is still recruiting patients who were first posted on January 27th of 2022 and recently updated on November 29th of the same year. The goal is to enlist 80 individuals from 23 separate sites."

Answered by AI

Has CSL312 been tested for efficacy in other research endeavors?

"CSL312 was initially studied in 2021 at Queen Mary Hospital, University of Hong Kong. To date, over 18000 trials have been concluded and 2 studies are still active with one of the sites located in Ocala, Florida."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Pulmonary Associates Clinical Trials AZ
Temple University TMS
Other
Weill Cornell Medical Center
How many prior treatments have patients received?
0
2
What state do they live in?
New York

What questions have other patients asked about this trial?

How many times to visit Baylor per week?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

i have tried nintedanib and condition getting worse. I've tried several drugs and my system could not tolerate the side effects.
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Weill Cornell Medical Center: < 48 hours
Typically responds via
Email
~26 spots leftby Mar 2025