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GB0139 for Idiopathic Pulmonary Fibrosis

Phase 2
Waitlist Available
Led By Toby Maher, MD, PhD
Research Sponsored by Galecto Biotech AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 12, 26 and 52
Awards & highlights

Study Summary

This trial is investigating whether the drug GB0139 is effective and safe for treating idiopathic pulmonary fibrosis.

Eligible Conditions
  • Idiopathic Pulmonary Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 12, 26 and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 12, 26 and 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
Annual rate of decline in Forced Vital Capacity (FVC)
Secondary outcome measures
Absolute decline in FVC >10%
Assessment of Respiratory Related Quality of Life using the St. George's Respiratory Questionnaire (SGRQ)
Time to death
+1 more
Other outcome measures
6-minute walk test (6MWT) distance
Absolute decline in FVC >5%
Annual rate of decline in FVC in subjects never treated with pirfenidone or nintedanib
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: A. GB0139 3 mg once a dayExperimental Treatment1 Intervention
Inhalation of GB0139
Group II: B. Placebo once a dayPlacebo Group1 Intervention
Inhalation of Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GB0139
2019
Completed Phase 2
~430

Find a Location

Who is running the clinical trial?

Galecto Biotech ABLead Sponsor
8 Previous Clinical Trials
406 Total Patients Enrolled
1 Trials studying Idiopathic Pulmonary Fibrosis
60 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Syneos HealthOTHER
172 Previous Clinical Trials
68,028 Total Patients Enrolled
bioRASI, LLCIndustry Sponsor
13 Previous Clinical Trials
3,230 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA given authorization for GB0139?

"All available data points to GB0139's safety, thus receiving a score of 2 on our team's rating scale. This drug is currently in Phase 2 clinical trials — there has been some evidence found regarding its security but no efficacy outcomes have yet been established."

Answered by AI

Are current enrollees being accepted for this research experiment?

"According to clinicaltrials.gov, the recruitment period for this medical trial has now come to a close. The initial post was made on February 19th 2019 and the latest update dates back to May 23rd 2022. Fortunately, 412 other trials are still welcoming participants at present."

Answered by AI

Are there multiple locales conducting this clinical experiment within the jurisdiction?

"Avanza Medical Research Center in Pensacola, Florida; Broward Research Center in Pembroke Pines, Virginia and TPMG Clinical Research in Williamsburg, Georgia are three of the 24 medical centres currently enrolling for this trial."

Answered by AI

Is this research the initial of its kind?

"Since its inception in 2019, GB0139 has undergone extensive testing. Initially sponsored by bioRASI LLC, the first trial of 426 participants led to receive Phase 2 drug approval. Currently two active studies are examining GB0139 across 64 cities and 14 countries worldwide."

Answered by AI

Have there been any other examinations conducted involving GB0139?

"Currently, two trials are running for GB0139 with neither of them in the third stage. Most studies related to this medication take place in Marseille, Indiana but there is a total of 126 sites where these experiments are being conducted."

Answered by AI

What is the cumulative enrollment for this clinical research project?

"Unfortunately, this medical trial has stopped recruiting patients. It was first listed on February 19th and most recently updated on May 23rd of 2022. In the mean time, 410 trials are running for usual interstitial pneumonia while 2 studies are enrolling participants for GB0139."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
What portion of applicants met pre-screening criteria?
Did not meet criteria
~69 spots leftby Apr 2025