What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) are nintedanib and pirfenidone. Nintedanib often causes gastrointestinal side effects, with diarrhea being the most frequent, along with nausea and liver enzyme elevation. Pirfenidone commonly leads to gastrointestinal issues such as nausea and dyspepsia, as well as skin-related side effects like rash and photosensitivity. Both medications aim to slow disease progression but come with these notable side effects that patients should discuss with their healthcare providers.

What prior FDA approvals exist?

The FDA has approved two primary drugs for the treatment of Idiopathic Pulmonary Fibrosis (IPF): nintedanib and pirfenidone. Nintedanib is a receptor blocker for multiple tyrosine kinases that mediate fibrogenic growth factors, while pirfenidone is an antifibrotic agent that reduces lung fibrosis and inflammation. Both drugs have been shown to slow disease progression and reduce the frequency of acute exacerbations in IPF patients. These treatments differ from the anti-factor XIIa antibody (CSL312) currently under study, which targets a different pathway in the disease process.

What other types of research exist?

Promising novel alternatives to CSL312 for IPF patients include: 1) Pamrevlumab (FG-3019), an anti-CCN2 antibody, which has shown encouraging results in a Phase II clinical trial. 2) Pirfenidone, which has demonstrated efficacy in slowing disease progression and reducing mortality in multiple Phase III trials. 3) Tacrolimus, which, when combined with methylprednisolone, has shown improved survival rates in a small patient group. These alternatives have shown potential benefits in clinical studies and may be considered for treatment in 2024.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 22 weeks

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

Headache

Nasopharyngitis

Diarrhoea

Visual impairment

Conjunctivitis

Sinusitis

Urinary tract infection

Abdominal pain

Back pain

Oropharyngeal pain

Gastrointestinal infection

Pyrexia

Injection site erythema

Hereditary angioedema

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include antifibrotic agents such as nintedanib and pirfenidone. Nintedanib is a tyrosine kinase inhibitor that targets multiple growth factor receptors involved in the fibrotic process, thereby slowing disease progression. Pirfenidone has antifibrotic and anti-inflammatory properties, reducing fibroblast proliferation and collagen synthesis. These treatments are crucial for IPF patients as they help to slow the decline in lung function and reduce the frequency of acute exacerbations, improving overall survival. Additionally, investigational treatments like CSL312, an anti-factor XIIa antibody, aim to target specific pathways involved in coagulation and inflammation, potentially offering new therapeutic avenues for managing IPF.