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A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

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

Summary

This trial tests an inhaled medication called GB0139 for people with idiopathic pulmonary fibrosis (IPF). The drug aims to reduce lung damage by blocking a protein that causes inflammation and scarring.

Eligible Conditions
  • 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annual Rate of Decline in Forced Vital Capacity (FVC)
Secondary study objectives
Assessment of Respiratory Related Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)
Number of Participants With Respiratory Related Hospitalizations
Other study objectives
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

Side effects data

From 2023 Phase 2 trial • 172 Patients • NCT03832946
17%
Cough
13%
COVID-19
12%
Lower Respiratory Tract Infection
11%
Dyspnoea
8%
Diarrhoea
8%
Idiopathic pulmonary fibrosis
7%
Headache
6%
Productive Cough
6%
Bronchitis
5%
Back Pain
5%
Upper respiratory tract infection
5%
Urinary Tract Infection
4%
Dizziness
4%
Constipation
4%
Pneumonia
4%
Decreased Appetite
4%
Nasopharyngitis
4%
Oedema Peripheral
4%
Asthenia
4%
Weight Decreased
3%
Arthralgia
3%
Nausea
3%
Fall
3%
Gastrooesophageal reflux disease
3%
Tooth Abcess
3%
Hypoxia
3%
Epistaxis
3%
Hypertension
3%
Anxiety
2%
Skin Laceration
2%
Limb Injury
2%
Abdominal pain
2%
Musculoskeletal Chest Pain
2%
Tachycardia
2%
Rash
2%
Fatigue
2%
Atrial Fibrillation
2%
Sputum Increased
2%
Gout
2%
COVID-19 pneumonia
2%
Sepsis
2%
Septic Shock
2%
Tooth Infection
2%
Asthma
2%
Pyrexia
2%
Forced vital capacity decreased
2%
Basal Cell Carcinoma
1%
Spinal compression fracture
1%
Atrioventricular block first degree
1%
Hemiparesis
1%
Bronchial Obstruction
1%
Suicidal ideation
1%
Ischaemic stroke
1%
Rhinitis allergic
1%
Pain in extremity
1%
Sputum Discoloured
1%
Cardiac failure
1%
Cerebrovascular accident
1%
Localised Infection
1%
Rash maculo-papular
1%
Metastases to skin
1%
Neuroendocrine tumour of the lung
1%
Cerebral microangiopathy
1%
Bronchitis Bacterial
1%
Muscle Spasms
1%
Musculoskeletal stiffness
1%
Rotator cuff syndrome
1%
Hiatus hernia
1%
Lethargy
1%
Vaccination Complication
1%
Renal Cyst
1%
Cardiac arrest
1%
Hyperhidrosis
1%
Joint Stiffness
1%
Contusion
1%
Acarodermatitis
1%
Dyspnoea Exertional
1%
Chest wall haematoma
1%
Vomiting
1%
Sciatica
1%
Arteriosclerosis coronary artery
1%
Eyelid contusion
1%
Nasal Congestion
1%
Acute myocardial infarction
1%
Flatulence
1%
Tremor
1%
Eye Injury
1%
Acute respiratory failure
1%
Acute respiratory distress syndrome
1%
Coronavirus infection
1%
Coronary artery disease
1%
Ventricular fibrillation
1%
Necrosis
1%
Abdominal Injury
1%
Craniocerebral injury
1%
Rib fracture
1%
Acute kidney injury
1%
Peripheral ischaemia
1%
Gastroenteritis
1%
Tracheitis
1%
Coronavirus Infection
1%
Gingivitis
1%
Influenza
1%
Pharyngitis
1%
Root Canal Infection
1%
Viral Upper Respiratory Tract Infection
1%
Wheezing
1%
Dysphonia
1%
Oropharyngeal pain
1%
Pulmonary embolism
1%
Malaise
1%
Vaccination Site Pain
1%
Feeling Cold
1%
Influenza Like Illness
1%
Vaccination Site Rash
1%
Joint Swelling
1%
Limb Mass
1%
Muscular weakness
1%
Musculoskeletal pain
1%
Abdominal distension
1%
Diverticulum intestinal
1%
Dyspepsia
1%
Eructation
1%
Gingival cyst
1%
Mouth ulceration
1%
Memory impairment
1%
Neuropathy peripheral
1%
Paraesthesia
1%
Presyncope
1%
Sensory loss
1%
Bundle branch block left
1%
Myocardial hypoxia
1%
Palpitations
1%
Sinus bradycardia
1%
Abnormal loss of weight
1%
Glucose tolerance impaired
1%
Iron deficiency
1%
Malnutrition
1%
Type 2 diabetes mellitus
1%
Vitamin D deficiency
1%
Muscle Injury
1%
Road Traffic Accident
1%
Soft Tissue Injury
1%
Tendon rupture
1%
Thermal burn
1%
Anticoagulation drug level above therapeutic
1%
Blood glucose increased
1%
Heart rate increased
1%
Seborrhoeic keratosis
1%
Hypotension
1%
Aortic arteriosclerosis
1%
Haematoma
1%
Insomnia
1%
Cataract
1%
Dry eye
1%
Eye haematoma
1%
Eye pain
1%
Nephrolithiasis
1%
Benign prostatic hyperplasia
1%
Prostatic atrophy
1%
Excessive cerumen production
1%
Vertigo positional
1%
Hypothyroidism
1%
Rib Fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
A. GB0139 3 mg Once a Day
B. Placebo Once a Day

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
~180

Find a Location

Who is running the clinical trial?

Galecto Biotech ABLead Sponsor
8 Previous Clinical Trials
406 Total Patients Enrolled
Syneos HealthOTHER
176 Previous Clinical Trials
68,483 Total Patients Enrolled
bioRASI, LLCIndustry Sponsor
13 Previous Clinical Trials
3,230 Total Patients Enrolled
Toby Maher, MD, PhDPrincipal InvestigatorKeck Medicine of USC
~25 spots leftby Dec 2025
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