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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
Assessment of Respiratory Related Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)
Number of Participants With Respiratory Related Hospitalizations
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

Side effects data

From 2023 Phase 2 trial • 172 Patients • NCT03832946
17%
Cough
13%
COVID-19
12%
Lower Respiratory Tract Infection
11%
Dyspnoea
8%
Idiopathic pulmonary fibrosis
8%
Diarrhoea
7%
Headache
6%
Bronchitis
6%
Productive Cough
5%
Upper respiratory tract infection
5%
Back Pain
5%
Urinary Tract Infection
4%
Constipation
4%
Pneumonia
4%
Nasopharyngitis
4%
Dizziness
4%
Weight Decreased
4%
Oedema Peripheral
4%
Asthenia
4%
Decreased Appetite
3%
Hypoxia
3%
Hypertension
3%
Anxiety
3%
Fall
3%
Arthralgia
3%
Tooth Abcess
3%
Epistaxis
3%
Nausea
3%
Gastrooesophageal reflux disease
2%
Musculoskeletal Chest Pain
2%
Abdominal pain
2%
Rash
2%
Pyrexia
2%
Asthma
2%
Forced vital capacity decreased
2%
Septic Shock
2%
COVID-19 pneumonia
2%
Tooth Infection
2%
Sputum Increased
2%
Tachycardia
2%
Sepsis
2%
Atrial Fibrillation
2%
Gout
2%
Limb Injury
2%
Skin Laceration
2%
Basal Cell Carcinoma
2%
Fatigue
1%
Localised Infection
1%
Abdominal Injury
1%
Craniocerebral injury
1%
Gingivitis
1%
Viral Upper Respiratory Tract Infection
1%
Sputum Discoloured
1%
Joint Swelling
1%
Hiatus hernia
1%
Palpitations
1%
Sinus bradycardia
1%
Road Traffic Accident
1%
Eye haematoma
1%
Coronary artery disease
1%
Influenza Like Illness
1%
Acute kidney injury
1%
Pharyngitis
1%
Abdominal distension
1%
Cardiac failure
1%
Soft Tissue Injury
1%
Heart rate increased
1%
Cataract
1%
Neuroendocrine tumour of the lung
1%
Oropharyngeal pain
1%
Peripheral ischaemia
1%
Vaccination Site Pain
1%
Muscle Spasms
1%
Diverticulum intestinal
1%
Gingival cyst
1%
Lethargy
1%
Neuropathy peripheral
1%
Paraesthesia
1%
Arteriosclerosis coronary artery
1%
Dysphonia
1%
Muscle Injury
1%
Contusion
1%
Tendon rupture
1%
Suicidal ideation
1%
Nephrolithiasis
1%
Excessive cerumen production
1%
Vertigo positional
1%
Hypothyroidism
1%
Rib Fracture
1%
Eyelid contusion
1%
Insomnia
1%
Nasal Congestion
1%
Thermal burn
1%
Benign prostatic hyperplasia
1%
Necrosis
1%
Pulmonary embolism
1%
Musculoskeletal pain
1%
Dyspepsia
1%
Eructation
1%
Mouth ulceration
1%
Atrioventricular block first degree
1%
Malnutrition
1%
Spinal compression fracture
1%
Hyperhidrosis
1%
Dry eye
1%
Acute respiratory distress syndrome
1%
Acute respiratory failure
1%
Acute myocardial infarction
1%
Coronavirus infection
1%
Cardiac arrest
1%
Ventricular fibrillation
1%
Rib fracture
1%
Cerebral microangiopathy
1%
Cerebrovascular accident
1%
Acarodermatitis
1%
Coronavirus Infection
1%
Influenza
1%
Root Canal Infection
1%
Rhinitis allergic
1%
Malaise
1%
Vaccination Site Rash
1%
Chest wall haematoma
1%
Joint Stiffness
1%
Limb Mass
1%
Muscular weakness
1%
Musculoskeletal stiffness
1%
Pain in extremity
1%
Rotator cuff syndrome
1%
Flatulence
1%
Hemiparesis
1%
Renal Cyst
1%
Prostatic atrophy
1%
Metastases to skin
1%
Ischaemic stroke
1%
Gastroenteritis
1%
Bronchitis Bacterial
1%
Tracheitis
1%
Wheezing
1%
Bronchial Obstruction
1%
Dyspnoea Exertional
1%
Feeling Cold
1%
Myocardial hypoxia
1%
Vomiting
1%
Sciatica
1%
Memory impairment
1%
Presyncope
1%
Bundle branch block left
1%
Sensory loss
1%
Tremor
1%
Type 2 diabetes mellitus
1%
Abnormal loss of weight
1%
Glucose tolerance impaired
1%
Iron deficiency
1%
Vitamin D deficiency
1%
Vaccination Complication
1%
Eye Injury
1%
Anticoagulation drug level above therapeutic
1%
Blood glucose increased
1%
Seborrhoeic keratosis
1%
Hypotension
1%
Haematoma
1%
Aortic arteriosclerosis
1%
Rash maculo-papular
1%
Eye pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
B. Placebo Once a Day
A. GB0139 3 mg 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
172 Previous Clinical Trials
68,031 Total Patients Enrolled
bioRASI, LLCIndustry Sponsor
13 Previous Clinical Trials
3,230 Total Patients Enrolled
~28 spots leftby Jun 2025
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