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Updated May 2026 · ClinicalTrials.gov

Phase 3 Interstitial Lung Disease Trials

11 Phase 3 trials for Interstitial Lung Disease, the final stage before a treatment can be submitted for FDA approval.

11 Phase 3 clinical trials for Interstitial Lung Disease are registered on ClinicalTrials.gov. Phase 3 is the final stage of testing before a treatment can be submitted for FDA approval, and the trials below come directly from the federal registry. Always talk to your doctor before contacting a study site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

What Phase 3 Means for Interstitial Lung Disease

Phase 3 trials are the largest and most expensive stage of clinical research before potential FDA approval. For Interstitial Lung Disease, a Phase 3 protocol typically enrolls several hundred to several thousand patients across many medical centers, randomizes participants between the investigational treatment and either a placebo or current standard of care (where ethically appropriate), and tracks them for months or years to confirm that the treatment is both effective and safe in a real-world patient population.

11 Phase 3 trials for Interstitial Lung Disease are currently registered. Conditions in this range often have a focused research agenda with a small number of late-stage candidates, frequently targeting a specific subpopulation or stage of the disease.

Boehringer Ingelheim (2), Insmed Incorporated (1), National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland (1) lead the Phase 3 Interstitial Lung Disease sponsor list. The blend of industry, academic, and government sponsors on a condition's Phase 3 list is a useful signal of how broadly the research community is engaged with the disease.

Phase 3 Interstitial Lung Disease Trials on ClinicalTrials.gov

RECRUITINGPhase 3NCT07179380

Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension...

The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.

Sponsor: Insmed IncorporatedEnrolling: 34420 locations
RECRUITINGPhase 3NCT06297096

Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease

The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination...

Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, PolandEnrolling: 861 location
RECRUITINGPhase 3NCT05943535

Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)

Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.

Sponsor: United TherapeuticsEnrolling: 69820 locations
RECRUITINGPhase 3NCT04965298

Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole

IPF is a progressive scarring lung condition causing coughing and breathlessness. IPF patients often have reflux disease meaning stomach acid may be breathed into the lungs,...

Sponsor: Norfolk and Norwich University Hospitals NHS Foundation TrustEnrolling: 29820 locations
RECRUITINGPhase 3NCT05288179

Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis

This study is a randomized, double-blind, placebo-controlled, multicenter clinical study. The main purpose of this study was to confirm the efficacy and safety of pirfenidone...

Sponsor: Beijing Continent Pharmaceutical Co, Ltd.Enrolling: 2721 location
RECRUITINGPhase 3NCT07082842

Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF

A multicenter, parallel, randomized, placebo (double-blind) and pirfenidone (open-label) controlled Phase III clinical trial to evaluate the efficacy and safety of HEC585 in...

Sponsor: Sunshine Lake Pharma Co., Ltd.Enrolling: 4721 location
RECRUITINGPhase 3NCT07464912

A Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic...

This study is a multicentre, randomised, double-blind, placebo-controlled, adaptive design clinical trial to evaluate the efficacy and safety of TDI01 suspension in the treatment...

Sponsor: Beijing Tide Pharmaceutical Co., LtdEnrolling: 5081 location
RECRUITINGPhase 3NCT06238622

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a...

This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a...

Sponsor: Boehringer IngelheimEnrolling: 170020 locations
RECRUITINGPhase 3NCT04943211

Determination of Molecular Status, the Efficacy and Safety of Fluorodeoxyglucose in PET-CT Imaging

Prospective, low intervention, open, single-center, non-commercial clinical trial to improve diagnostics in patients with histiocytosis by assessing the molecular profile of the...

Sponsor: Anna RaciborskaEnrolling: 1501 location
RECRUITINGPhase 3NCT04871191

Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis

The purpose of this study is to identify the most promising therapeutic strategy for patients with granulomatosis with polyangiitis and inadequate response to standard of care...

Sponsor: Assistance Publique - Hôpitaux de ParisEnrolling: 421 location
RECRUITINGPhase 3NCT06806592

A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases

Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if...

Sponsor: Boehringer IngelheimEnrolling: 40020 locations

What Participation Looks Like

Phase 3 trials for Interstitial Lung Disease typically enroll several hundred to several thousand participants across multiple sites. Participation involves a screening visit to confirm eligibility, randomization to either the investigational treatment or a comparator (often the current standard of care), regular study visits over months or years, and follow-up after the active treatment period. The protocols, time commitments, and visit schedules differ from trial to trial — read the per-trial page for the specifics before discussing participation with your doctor.

Each trial begins with informed consent and a screening visit, where the study team confirms eligibility against the inclusion and exclusion criteria. Randomization assigns participants to either the investigational treatment or a comparator. Standard-of-care portions of the protocol are typically billed to insurance; trial-specific procedures (extra imaging, biopsies, lab draws beyond standard care) are usually covered by the sponsor. Read each trial\'s detailed page for its specific time commitment and visit schedule.

Authoritative Resources for Interstitial Lung Disease Trials

Verify any individual trial directly on ClinicalTrials.gov. For the federal context on how Phase 3 results feed into approval decisions, see the FDA drug approval process. For oncology-specific trial resources, the National Cancer Institute publishes patient-oriented overviews. For trials registered outside the U.S., the WHO ICTRP aggregates registries from around the world.

Frequently Asked Questions

What is a Phase 3 Interstitial Lung Disease trial?

A Phase 3 trial is the final stage of clinical testing before a treatment can be submitted to the FDA for approval. For Interstitial Lung Disease, Phase 3 studies typically enroll hundreds to thousands of patients across multiple medical centers, comparing the new treatment to the current standard of care or a placebo (where ethically appropriate). The goal is to confirm efficacy, monitor side effects in a larger population, and generate the evidence the FDA needs to make an approval decision.

How many Phase 3 Interstitial Lung Disease trials are recruiting?

11 Phase 3 trials for Interstitial Lung Disease are currently registered on ClinicalTrials.gov. Recruitment status varies by trial — some are actively enrolling, some have closed enrollment but are still in the active treatment phase, and some are completing follow-up. Click any trial below to see its current status, eligibility criteria, and contact information.

Who can participate in a Phase 3 Interstitial Lung Disease trial?

Phase 3 eligibility depends entirely on the specific trial protocol. Each trial sets its own inclusion criteria (typically a confirmed diagnosis, certain disease stage or severity, age range) and exclusion criteria (often previous treatments, comorbidities, lab values that fall outside set ranges). The trial pages on this site translate the clinical eligibility criteria into plain English alongside the original text. Whether you fit any specific trial is a medical decision your doctor needs to confirm.

Is participating in a Phase 3 Interstitial Lung Disease trial safe?

Phase 3 trials use treatments that have already passed Phase 1 (safety in small groups) and Phase 2 (initial efficacy and side-effect monitoring), so the safety profile is better understood than in earlier-phase studies. That said, side effects can still emerge in larger populations, and the trial protocol may require additional procedures (lab draws, imaging, biopsies) beyond standard care. The informed consent document for any specific trial details the known risks. Discuss those risks with your physician before deciding whether to participate.

Where does this trial data come from?

All trial data is sourced from the ClinicalTrials.gov API v2, the federal registry maintained by the National Library of Medicine at NIH. Under FDAAA 801, most U.S. drug and device trials must register on ClinicalTrials.gov, making it the most comprehensive source of trial information. Sponsors are required to update trial status within 30 days of a change, but delays occur — always confirm the current status with the trial site before traveling for screening.

How This Page Is Built

The trial list is filtered to ClinicalTrials.gov registrations whose phase field includes Phase 3 and whose condition list includes Interstitial Lung Disease. Trial counts and the sponsor leaderboard are computed from the same record set. Plain-English eligibility translations on each linked trial page preserve the original clinical text alongside the accessible version. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2, maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData, Phase 3 Interstitial Lung Disease list, May 2026. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · 11 Phase 3 trials tracked for Interstitial Lung Disease.

The this entity category groups every U.S. clinical trials and research registries entity sharing this attribute. The list above is the data; the paragraphs below explain what the grouping means against the broader the NIH ClinicalTrials.gov registry distribution and how to read the relative rankings within the category.

For readers using this category as a starting point, the per-entity detail pages linked from the table above carry the underlying the NIH ClinicalTrials.gov registry data in full. The category-level view is the filter; the per-entity pages are the actual answer.