---
title: A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
nct_id: NCT02538536
overall_status: COMPLETED
phase: PHASE2
sponsor: Liminal BioSciences Ltd.
study_type: INTERVENTIONAL
primary_condition: Idiopathic Pulmonary Fibrosis (IPF)
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02538536.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02538536"
ct_last_update_post_date: 2019-04-17
last_seen_at: "2026-05-12T07:20:53.413Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

**Official Title:** A Phase 2, Open-label, Single Arm, Exploratory, Observational Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

**NCT ID:** [NCT02538536](https://clinicaltrials.gov/study/NCT02538536)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 41
- **Lead Sponsor:** Liminal BioSciences Ltd.
- **Conditions:** Idiopathic Pulmonary Fibrosis (IPF)
- **Start Date:** 2015-07
- **Completion Date:** 2017-01
- **CT.gov Last Update:** 2019-04-17

## Brief Summary

This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050 800 mg daily oral administration in 40 adult patients with IPF.

## Detailed Description

This Phase 2 multi-centre study will be performed by 6 Canadian sites. It is an open-label, single-arm study in patients with Idiopathic Pulmonary Fibrosis (IPF) aged 40 years and older.

The duration of study participation is approximately 20 weeks for each patient and comprises 6 study visits.

## Eligibility

- **Minimum age:** 40 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Patient is an adult aged 40 years or older
2. Patient has signed written informed consent.
3. Patient has been diagnosed of IPF according to the most recent guideline on IPF diagnosis and management released by American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Association (ALAT).
4. Female patients of childbearing potential must have a negative urine pregnancy test and agree to use adequate birth control from screening throughout the study and for 30 days after the last study drug administration.
5. If a male patient has not been vasectomized at least 6 months before screening and partners with a woman of childbearing potential, he must be willing to use an acceptable contraceptive method throughout the study and for 30 days after the last study drug administration.

Exclusion Criteria:

1. Patient has a known diagnosis of a respiratory disorder other than IPF.
2. Substantial emphysema on high resolution computer tomography (HRCT) with degree of emphysema greater than fibrosis.
3. Patient is an active smoker.
4. Patient has evidence of active infection.
5. Patients currently has or has a history of cancer, except basal cell carcinoma or squamous cell carcinoma of the skin.
6. Patient has a concurrent medical or psychological condition that, in the investigator's opinion, may compromise the patient's ability to participate in the study or give informed consent, or may complicate the evaluations of the study drug.
7. Patient is receiving another investigational treatment for IPF at screening and/or plans to receive an investigational treatment for IPF during the current study.
8. Patient has chronic hepatitis or significantly elevated liver enzyme levels, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × upper limit of normal (ULN) or total bilirubin above ULN.
9. Female patient who is pregnant, breast-feeding, or planning a pregnancy during the course of the study.
10. Woman of childbearing potential who is unwilling to use adequate birth control throughout the duration of the study.
11. Patient has participated in an investigational clinical trial during the last 4 weeks.
```

## Arms

- **PBI4050** (EXPERIMENTAL) — Four 200 mg capsules (total 800 mg) administered orally, once daily.

## Interventions

- **PBI4050** (DRUG)

## Primary Outcomes

- **Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment** _(time frame: 4 months)_

## Secondary Outcomes

- **Change from baseline on pulmonary function tests** _(time frame: 3 months)_
- **Change from baseline in imaging of thorax** _(time frame: 3 months)_
- **Change from baseline on biomarkers** _(time frame: 3 months)_

## Locations (5)

- Vancouver, British Columbia, Canada
- Halifax, Nova Scotia, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Sherbrooke, Quebec, Canada

## Recent Field Changes (last 30 days)

- `locations.|montreal|quebec|canada` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|vancouver|british columbia|canada` — added _(2026-05-12)_
- `locations.|halifax|nova scotia|canada` — added _(2026-05-12)_
- `locations.|toronto|ontario|canada` — added _(2026-05-12)_
- `locations.|sherbrooke|quebec|canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02538536.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02538536*  
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