LTP001 for Idiopathic Pulmonary Fibrosis

Recruiting at 34 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must be taking: Nintedanib, Pirfenidone

Disqualifiers: Airway obstruction, Emphysema, Connective tissue disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 26 weeks

46 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing different individual treatments to see how well they work and how safe they are. It focuses on people with idiopathic pulmonary fibrosis, a serious lung disease. The goal is to find treatments that can improve lung function and reduce symptoms. Nintedanib and pirfenidone are antifibrotic agents that have been used in the treatment of idiopathic pulmonary fibrosis.

Will I have to stop taking my current medications?

If you are taking nintedanib or pirfenidone, you must continue on a stable dose for at least 8 weeks before joining the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

How does the drug LTP001 work differently from other treatments for idiopathic pulmonary fibrosis?

LTP001 is unique because it targets the regulation of TGF-β (a protein involved in cell growth and repair) by focusing on proteins like LTBP-1 and LTBP-2, which are involved in its storage and activation. This approach may help control the excessive tissue scarring seen in idiopathic pulmonary fibrosis by modulating the activity of TGF-β in the lungs. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults at least 40 years old with idiopathic pulmonary fibrosis (IPF), a type of lung scarring. Participants must have certain levels of lung function and be on stable IPF medication if applicable. They shouldn't have major airway blockage, significant emphysema, connective tissue disease, or recent worsening of their condition.

Inclusion Criteria

I am 40 years old or older.

Your lung function should be at least 25% of what is expected for someone your age and size.

I have been on a steady dose of nintedanib or pirfenidone for at least 8 weeks.

Exclusion Criteria

I have been diagnosed with a connective tissue disease.

I have breathing issues due to airway obstruction or respond to inhalers.

You have less than 10% fibrosis on the lung scan done during screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LTP001 or placebo orally once daily for approximately 26 weeks

26 weeks

Visits at baseline, Weeks 4, 8, 12, 16, 20, 26

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LTP001

Trial Overview The study tests the effectiveness and safety of LTP001 against a placebo while all participants continue receiving standard care for IPF. It's blinded so neither the researchers nor participants know who gets the real treatment versus placebo, and people are chosen randomly to receive one or the other.

Participant Groups

Group I: Placebo Experimental Treatment 2 Interventions

Participants will receive LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 26 weeks

Group II: LTP001 Experimental Treatment 2 Interventions

Participants will receive LTP001 orally once daily in the morning for approximately 26 weeks

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

References

1. Germany pubmed.ncbi.nlm.nih.gov

Regulation of TGF-β storage and activation in the human idiopathic pulmonary fibrosis lung. [2016]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Latent Transforming Growth Factor-β Binding Protein-2 Regulates Lung Fibroblast-to-Myofibroblast Differentiation in Pulmonary Fibrosis via NF-κB Signaling. [2022]

3. France pubmed.ncbi.nlm.nih.gov

[Idiopathic interstitial pneumonias]. [2014]

4. England pubmed.ncbi.nlm.nih.gov

LTBP2 is secreted from lung myofibroblasts and is a potential biomarker for idiopathic pulmonary fibrosis. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Familial idiopathic pulmonary fibrosis: clinical features and outcome. [2009]