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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

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
  • 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

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%
Upper respiratory tract infection
5%
Urinary Tract Infection
5%
Back Pain
4%
Weight Decreased
4%
Asthenia
4%
Dizziness
4%
Nasopharyngitis
4%
Oedema Peripheral
4%
Decreased Appetite
4%
Pneumonia
4%
Constipation
3%
Tooth Abcess
3%
Gastrooesophageal reflux disease
3%
Fall
3%
Anxiety
3%
Arthralgia
3%
Epistaxis
3%
Hypoxia
3%
Hypertension
3%
Nausea
2%
Musculoskeletal Chest Pain
2%
Sputum Increased
2%
Rash
2%
Gout
2%
Limb Injury
2%
Skin Laceration
2%
Forced vital capacity decreased
2%
Tooth Infection
2%
Atrial Fibrillation
2%
Pyrexia
2%
Asthma
2%
Basal Cell Carcinoma
2%
Sepsis
2%
Septic Shock
2%
COVID-19 pneumonia
2%
Abdominal pain
2%
Tachycardia
2%
Fatigue
1%
Dysphonia
1%
Vaccination Site Rash
1%
Lethargy
1%
Craniocerebral injury
1%
Eye pain
1%
Renal Cyst
1%
Joint Swelling
1%
Tremor
1%
Coronavirus Infection
1%
Joint Stiffness
1%
Gingival cyst
1%
Cardiac failure
1%
Viral Upper Respiratory Tract Infection
1%
Arteriosclerosis coronary artery
1%
Abnormal loss of weight
1%
Eye haematoma
1%
Gastroenteritis
1%
Eructation
1%
Presyncope
1%
Vertigo positional
1%
Bronchitis Bacterial
1%
Vaccination Site Pain
1%
Hypothyroidism
1%
Acarodermatitis
1%
Wheezing
1%
Nasal Congestion
1%
Muscle Spasms
1%
Necrosis
1%
Hiatus hernia
1%
Rib fracture
1%
Abdominal distension
1%
Tracheitis
1%
Gingivitis
1%
Root Canal Infection
1%
Malnutrition
1%
Feeling Cold
1%
Vomiting
1%
Sciatica
1%
Type 2 diabetes mellitus
1%
Tendon rupture
1%
Thermal burn
1%
Blood glucose increased
1%
Heart rate increased
1%
Seborrhoeic keratosis
1%
Hypotension
1%
Aortic arteriosclerosis
1%
Haematoma
1%
Suicidal ideation
1%
Localised Infection
1%
Acute kidney injury
1%
Malaise
1%
Vitamin D deficiency
1%
Pulmonary embolism
1%
Sputum Discoloured
1%
Diverticulum intestinal
1%
Paraesthesia
1%
Iron deficiency
1%
Nephrolithiasis
1%
Bronchial Obstruction
1%
Rotator cuff syndrome
1%
Vaccination Complication
1%
Contusion
1%
Pharyngitis
1%
Influenza Like Illness
1%
Dyspepsia
1%
Memory impairment
1%
Insomnia
1%
Rhinitis allergic
1%
Influenza
1%
Metastases to skin
1%
Neuroendocrine tumour of the lung
1%
Acute respiratory distress syndrome
1%
Coronary artery disease
1%
Ventricular fibrillation
1%
Coronavirus infection
1%
Acute respiratory failure
1%
Cerebral microangiopathy
1%
Peripheral ischaemia
1%
Abdominal Injury
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Acute myocardial infarction
1%
Cardiac arrest
1%
Dyspnoea Exertional
1%
Oropharyngeal pain
1%
Chest wall haematoma
1%
Limb Mass
1%
Muscular weakness
1%
Musculoskeletal stiffness
1%
Pain in extremity
1%
Musculoskeletal pain
1%
Flatulence
1%
Mouth ulceration
1%
Hemiparesis
1%
Neuropathy peripheral
1%
Sensory loss
1%
Atrioventricular block first degree
1%
Bundle branch block left
1%
Myocardial hypoxia
1%
Palpitations
1%
Sinus bradycardia
1%
Glucose tolerance impaired
1%
Eye Injury
1%
Eyelid contusion
1%
Muscle Injury
1%
Spinal compression fracture
1%
Road Traffic Accident
1%
Soft Tissue Injury
1%
Anticoagulation drug level above therapeutic
1%
Hyperhidrosis
1%
Rash maculo-papular
1%
Cataract
1%
Dry eye
1%
Benign prostatic hyperplasia
1%
Prostatic atrophy
1%
Excessive cerumen production
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
1 Trials studying Idiopathic Pulmonary Fibrosis
60 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Syneos HealthOTHER
175 Previous Clinical Trials
68,227 Total Patients Enrolled
bioRASI, LLCIndustry Sponsor
13 Previous Clinical Trials
3,230 Total Patients Enrolled
~26 spots leftby Oct 2025
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