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Anti-fibrotic agent

AP01 Low Dose BID for Pulmonary Fibrosis

Phase 2

Recruiting

Research Sponsored by Avalyn Pharma Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Worsening respiratory symptoms with no alternative explanation

Radiological evidence of disease progression including increased extent or severity of traction bronchiectasis and bronchiolectasis, new ground-glass opacity with traction bronchiectasis, new fine reticulation, increased extent or increased coarseness of reticular abnormality, new or increased honeycombing, increased lobar volume loss

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

Study Summary

This trial will test whether a new drug, AP01, is safe and effective in treating a specific condition when added to standard treatment. Participants will receive either AP01 or a placebo for 52 weeks

Who is the study for?

This trial is for people with Progressive Pulmonary Fibrosis who have worsening respiratory symptoms, an FVC of at least 45%, and a DLCO of at least 30%. Those on nintedanib must meet specific criteria related to their treatment duration and stability. Participants need to be able to perform acceptable spirometry tests.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of two doses of AP01 compared to a placebo in addition to standard care over one year. It's randomized, meaning participants are put into groups by chance, double-blind so neither they nor the researchers know who gets what, and placebo-controlled for comparison.See study design

What are the potential side effects?

While not specified here, common side effects in trials like this may include gastrointestinal issues (like nausea or diarrhea), skin reactions (rash or itching), fatigue, coughing or shortness of breath that could worsen existing conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breathing problems are getting worse without any other known cause.

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My lung scans show worsening or new signs of lung damage.

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My lung function tests meet the required levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID)

Secondary outcome measures

To evaluate the change from baseline in quantitative lung fibrosis score.

To evaluate the effect of AP01 high dose and AP01 low dose compared to placebo on disease progression (defined as absolute FVC percent predicted decline of ≥10% prior to Week 52)

To evaluate the effect of AP01 high dose, AP01 low dose compared to placebo on quality of life (QoL)

Other outcome measures

To evaluate the safety of AP01 high dose and AP01 low dose compared to placebo

Side effects data

From 2019 Phase 3 trial • 60 Patients • NCT03208933

27%

Nausea

22%

Decreased appetite

13%

Vomiting

13%

Dyspepsia

12%

Diarrhoea

10%

Dyspnoea

Pruritus

Weight decreased

Cough

Idiopathic pulmonary fibrosis

Death

Bronchitis chronic

Bronchitis bacterial

Cholecystitis infective

Atrial flutter

Pneumonia

Adenocarcinoma of colon

Sudden cardiac death

Atrial fibrillation

100%

80%

60%

40%

20%

Study treatment Arm

Pirfenidone

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: AP01 Low Dose BIDExperimental Treatment1 Intervention

Pirfenidone Solution for Inhalation

Group II: AP01 High Dose BIDExperimental Treatment1 Intervention

Pirfenidone Solution for Inhalation

Group III: Placebo BIDPlacebo Group1 Intervention

Placebo solution for inhalation

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Avalyn Pharma Inc.Lead Sponsor

DevPro BiopharmaUNKNOWN

2 Previous Clinical Trials

219 Total Patients Enrolled

1 Trials studying Pulmonary Fibrosis

135 Patients Enrolled for Pulmonary Fibrosis

Avalyn Pharma, Inc.Study DirectorAvalyn Pharma Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many medical facilities is this examination being conducted?

"Enrollment is ongoing at various sites including Newport Native MD, Inc. in Newport Beach, Paradigm Clinical Research - Redding in Redding, and Renstar Medical Research in Ocala among 8 additional locations."

Answered by AI

What is the total number of subjects actively involved in this research investigation?

"Indeed, the latest details on clinicaltrials.gov indicate that this medical trial is actively seeking volunteers. Originally uploaded on April 3rd, 2024, and last revised on April 23rd, 2024, the study aims to enlist a total of 300 participants from eight distinct sites."

Answered by AI

Is this medical study currently open to new participants?

"Affirmative. Data available on clinicaltrials.gov affirms that enrollment for this trial is ongoing. The study was initially listed on April 3, 2024, and most recently modified on April 23, 2024. A total of 300 individuals are being sought across eight designated sites."

Answered by AI

What are the potential risks associated with administering AP01 Low Dose BID to individuals?

"According to our assessment at Power, the safety rating for AP01 Low Dose BID is 2 on a scale of 1 to 3. This rating corresponds to Phase 2 trials where there exists preliminary evidence supporting safety measures but no data backing efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating the Safety and Efficacy of AP01 in Participants With Progressive Pulmonary Fibrosis (PPF)

2024. "A Study Evaluating the Safety and Efficacy of AP01 in Participants With Progressive Pulmonary Fibrosis (PPF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06329401.

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