A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis

Plain English Summary

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis is a Phase 3 clinical trial sponsored by Bristol-Myers Squibb studying Progressive Pulmonary Fibrosis. Tests a new drug, BMS-986278, to see if it can slow lung damage in people with progressive pulmonary fibrosis. For adults with progressive pulmonary fibrosis who have had lung scarring for at least 2 years and are not taking certain medications. Participation involves taking the drug or a placebo for up to 3 years and having regular check-ups and tests. Alternative treatments include other medications like pirfenidone and nintedanib, but this study focuses on a new drug. The trial aims to enroll 1057 participants.

Official Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible participants must have had lung scarring for at least 2 years and are not taking certain medications. Participants must not have had a stroke or heart failure symptoms. Women of childbearing potential must use effective contraception. Men who are sexually active with women of childbearing potential must use male barrier contraception. This trial is studying Progressive Pulmonary Fibrosis, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures include changes in lung function and quality of life, which can help patients understand the drug's impact on their condition. The specific primary outcome measures are: Number of participants that experience spontaneous syncopal events (At approximately 4 weeks); Absolute change from baseline in forced vital capacity (FVC) measured in mL (At Week 52). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to fill a treatment gap for progressive pulmonary fibrosis, a condition with limited treatment options. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Progressive Pulmonary Fibrosis, where improved treatment options are needed.

Investor Insight

The large market size and the current lack of effective treatments make this trial significant, with a competitive landscape that includes other ongoing studies. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 1057 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if you have had lung scarring for at least 2 years and are not taking certain medications. Participation involves taking the drug or a placebo and having regular check-ups and tests. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 1,057 participants

Interventions

• DRUG: BMS-986278 — Specified dose on specified days
• DRUG: BMS-986278 Placebo — Specified dose on specified days

Primary Outcomes

• Number of participants that experience spontaneous syncopal events (At approximately 4 weeks)
• Absolute change from baseline in forced vital capacity (FVC) measured in mL (At Week 52)

Secondary Outcomes

• Number of participants who discontinued treatment due to any low BP-related Adverse Events (Up to approximately 3 years)
• Disease progression (Up to approximately 3 years)
• Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score (At Week 52 and up to approximately 3 years)
• Change from baseline in L-PF dyspnea domain score (At Week 52 and up to approximately 3 years)
• Change from baseline in walking distance measured in 6-minute walk test (6MWT) (At Week 52)

Full Eligibility Criteria

Inclusion Criteria

* Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis on screening high-resolution computed tomography (HRCT).
* If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
* If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
* Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening.
* Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening.
* Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken these medications within 28 days prior to screening.
* Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test.
* Men who are sexually active with women of childbearing potential agree to use male barrier contraception.

Exclusion Criteria

* Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening.
* History of stroke or transient ischemic attack within 3 months prior to screening.
* Participants who exhibit symptoms of heart failure at rest.
* Participants who have a current malignancy; a previous malignancy with less than 2 years free of recurrence; and a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
* Use of systemic corticosteroids equivalent to prednisone \> 15 mg/day is not allowed within 4 weeks prior to screening and during the study.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Trial Locations

• Local Institution - 0046, Birmingham, Alabama, United States
• Local Institution - 0314, Phoenix, Arizona, United States
• Local Institution - 0336, La Jolla, California, United States
• Local Institution - 0212, Los Angeles, California, United States
• Local Institution - 0019, Los Angeles, California, United States
• Local Institution - 0535, Newport Beach, California, United States
• Local Institution - 0366, Orange, California, United States
• Local Institution - 0341, Sacramento, California, United States
• Local Institution - 0015, San Francisco, California, United States
• Local Institution - 0352, Stanford, California, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Idiopathic pulmonary fibrosis
• COPD (Chronic Obstructive Pulmonary Disease)
• Interstitial lung disease
• Pulmonary hypertension
• Lung cancer
• Asthma
• Sarcoidosis
• Lupus
• Rheumatoid arthritis
• Scleroderma

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