LTP001 for Idiopathic Pulmonary Fibrosis

No longer recruiting at 42 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called LTP001 for individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring and breathing problems. The study will compare the effects of LTP001 to a placebo (a pill with no active ingredient) to determine if it improves symptoms and is safe to use. Participants will take the treatment once daily for about 26 weeks. Suitable candidates for this trial include those diagnosed with IPF, who have significant lung scarring, and have been on stable medication for at least 8 weeks. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in IPF treatment.

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.

Is there any evidence suggesting that LTP001 is likely to be safe for humans?

Research shows that LTP001 has been tested for safety in people with idiopathic pulmonary fibrosis, a lung disease that causes lung scarring. Earlier studies found no major safety issues. Notably, a recent trial stopped for reasons unrelated to safety, indicating that safety was not a concern. This suggests that LTP001 has generally been well-tolerated so far. However, like any treatment, monitoring for side effects as more people use it remains important. Prospective participants might find reassurance in knowing that LTP001 has passed safety checks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

LTP001 is unique because it offers a fresh approach to treating idiopathic pulmonary fibrosis by targeting different pathways than current treatments like pirfenidone and nintedanib. Unlike these standard options, which primarily focus on slowing disease progression, LTP001 aims to directly address underlying disease mechanisms. Researchers are excited about LTP001 because its novel oral administration could potentially improve patient compliance and convenience, offering a promising alternative that could enhance quality of life for those affected by this challenging condition.

What evidence suggests that LTP001 might be an effective treatment for idiopathic pulmonary fibrosis?

Research shows that LTP001, which participants in this trial may receive, might help treat idiopathic pulmonary fibrosis (IPF), a progressive lung disease. Early results suggest that taking LTP001 once a day could slow lung damage caused by IPF. Although the mechanism of LTP001 is not fully understood, initial data is encouraging. Clinical studies, including this trial comparing LTP001 to a placebo, continue to explore its safety and effectiveness for people with IPF. This treatment aims to offer new hope for managing this challenging condition. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Placebo Experimental Treatment 2 Interventions

Placebo orally once daily in the morning for approximately 26 weeks.

Group II: LTP001 Experimental Treatment 2 Interventions

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05497284

Study Details | NCT05497284 | To Assess the Efficacy of ... This was a randomized, placebo-controlled, participant- and investigator-blinded platform study in participants with idiopathic pulmonary fibrosis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11441789/

Emerging pharmacological options in the treatment ... Idiopathic pulmonary fibrosis (IPF) is a progressive fibrosing lung disease with a median survival of less than 5 years.

3. clinicaltrials.eu clinicaltrials.eu/inn/ltp001/

Ltp001 – Application in Therapy and Current Clinical ... Study on the Effectiveness and Safety of LTP001 for Patients with Idiopathic Pulmonary Fibrosis. Not Recruiting.

4. withpower.com withpower.com/trial/phase-2-pulmonary-fibrosis-9-2022-275b4

LTP001 for Idiopathic Pulmonary Fibrosis 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1043661824001907

The current landscape of antifibrotic therapy across ... Pirfenidone was the first antifibrotic drug approved against idiopathic pulmonary fibrosis (2011). Its mechanism of action is not fully understood. Initially ...

6. thepharmaletter.com thepharmaletter.com/pharmaceutical/novartis-halts-phase-ii-study-of-ltp001-in-idiopathic-pulmonary-fibrosis

Novartis halts Phase II study of LTP001 in idiopathic ... Novartis halted its Phase II IPF trial for LTP001, citing non-safety reasons. This move aligns with its strategy to streamline R&D, ...

7. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2021-005066-17/PL

Clinical Trials Register Study of efficacy and safety of various treatments in participants with idiopathic pulmonary fibrosis (IPF). A.4.1, Sponsor's protocol code ...