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

Sponsor

Galecto Biotech AB (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03832946

Collaborator

Syneos Health (Other), bioRASI, LLC (Industry)

426

Enrollment

120

Locations

Arms

51.4

Anticipated Duration (Months)

3.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, double-blind, placebo-controlled phase 2b trial in subjects with IPF (idiopathic pulmonary fibrosis) investigating the efficacy and safety of GB0139.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis (IPF)	Drug: GB0139 Drug: Placebo	Phase 2

Detailed Description

This study is designed to evaluate the efficacy and safety of GB0139, a galectin-3 inhibitor, administered by dry powder inhalation over 52 weeks. GB0139, given once per day, will be compared to placebo. GB0139 was previously known as TD139.

Study Design

Study Type:

Interventional

Actual Enrollment :

426 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

All subjects eligible for the study will be randomised into one of the two treatment arms: A. GB0139 3 mg once a day B. Placebo once a dayAll subjects eligible for the study will be randomised into one of the two treatment arms:GB0139 3 mg once a day B. Placebo once a day

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

This study is a double-blind study. The blinding will be maintained throughout the study.

Primary Purpose:

Treatment

Official Title:

GALACTIC-1 -A Randomized, Double-blind, Multicentre, Parallel, Placebo-controlled Phase 2b Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Investigating the Efficacy and Safety of GB0139, an Inhaled Galectin-3 Inhibitor Administered Via a Dry Powder Inhaler Over 52 Weeks

Actual Study Start Date :

Feb 19, 2019

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A. GB0139 3 mg once a day Inhalation of GB0139	Drug: GB0139 GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day. Other Names: TD139
Placebo Comparator: B. Placebo once a day Inhalation of Placebo	Drug: Placebo Placebo is administered as inhalation once a day

Arm

Intervention/Treatment

Experimental: A. GB0139 3 mg once a day

Inhalation of GB0139

Drug: GB0139

GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.

Other Names:

TD139

Placebo Comparator: B. Placebo once a day

Inhalation of Placebo

Drug: Placebo

Placebo is administered as inhalation once a day

Outcome Measures

Primary Outcome Measures

Annual rate of decline in Forced Vital Capacity (FVC) [52 weeks]
Efficacy of GB0139 as measured by the annual rate of decline in FVC expressed in mL

Secondary Outcome Measures

Absolute decline in FVC >10% [52 weeks]
Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of > 10%
Time to first hospitalization [52 weeks]
Time to first hospitalization (respiratory related, including acute exacerbation of IPF) expressed in days.
Time to death [52 weeks]
Time to death from all-causes, respiratory-related causes and/or caused by IPF expressed in days
Assessment of Respiratory Related Quality of Life using the St. George's Respiratory Questionnaire (SGRQ) [52 weeks]
Change from baseline in the SGRQ total score. The SGRQ is a 50-item questionnaire split into three domains: symptoms, activity and impact. Weighting of both individual domains and the total score produces a range from 0 to 100, with higher scores indicating a poorer health-related quality of life.

Other Outcome Measures

Absolute decline in FVC >5% [52 weeks]
Percentage of subjects with an absolute decline from baseline in FVC (% predicted) of > 5%
6-minute walk test (6MWT) distance [52 weeks]
Change from baseline in distance walked (metres) over 6 minutes
Diffusion capacity of the lung for carbon monoxide (DLCO) [52 weeks]
Change from baseline in DLCO, corrected for Hemaglobin (mmol/min/kPa)
Assessment of Dyspnea using the University of California San Diego - Shortness of Breath Questionnaire (UCSD - SOBQ) [Weeks 12, 26 and 52]
Change from baseline in UCSD - SOBQ Scored from 0-120 where a higher score indicates worse dyspnea
Assessment of Health Related Quality of Life (HRQoL) using the Short-Form 36-Item Health Survey (SF-36) [Weeks 12, 26 and 52]
The Medical Outcomes SF-36 It is a self-administered questionnaire of 36-items measuring eight dimensions of general HRQoL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively. A higher score indicates a more favourable state of health
Frequency of Adverse Events (AE) or Serious Adverse Events (SAE) [52 weeks]
Percentage of subjects with Adverse Events (AE) or Serious Adverse Events (SAE)
Time to hospitalization [52 weeks]
Time in days to first hospitalization from all causes
Time to hospitalization [52 weeks]
Time in days to first hospitalization (IPF related, including acute exacerbation of IPF)
Time to respiratory related death [52 weeks]
Time in days to death from respiratory related causes (including IPF)
Time to initiation of pirfenidone or nintedanib treatment [52 weeks]
Time in days to initiation of pirfenidone or nintedanib treatment in subjects not treated with pirfenidone or nintedanib at time of enrolment
Annual rate of decline in FVC in subjects never treated with pirfenidone or nintedanib [52 weeks]
Change in FVC expressed in mL for subjects who have never been treated with pirfenidone or nintedanib

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female subjects aged ≥ 40 years of age with a diagnosis of IPF established during the previous five years according to ATS/ERS/Fleischner criteria.
Lung function parameters as follows:
Forced Vital Capacity (FVC) > 45% of the predicted value at screening
Diffusion lung capacity for carbon monoxide (DLCO) (corrected for Hb) of 30% to 79% of the predicted value at screening
Subjects who currently are not being treated with nintedanib or pirfenidone; or cannot tolerate nintedanib or pirfenidone
Subjects must sign and date a written, IRB/EC approved informed consent form and any required authorization prior to initiation of any study procedures.

Exclusion Criteria:

Currently has significant airways obstruction: Forced Expiratory Volume in 1 s (FEV1)/Forced Vital Capacity (FVC) ratio of < 0.7 at screening.
Has clinical evidence of active infection, including, but not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis.
Has a history of malignancy within the last 2 years with the exception of basal cell carcinoma, chronic lymphocytic leukaemia (under observation) and prostate cancer requiring anti-androgens, localised treatment (minor surgery, radiotherapy) and/or managed by observation.
Has any condition other than IPF that, in the opinion of the investigator, is likely to result in the death of the subject within the next 2 years.
Presence of other disease that may interfere with testing procedures or in the judgement of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial.
Is likely to receive lung transplantation within the next 12 months.
Currently receiving nintedanib, pirfenidone, high dose corticosteroid, cytotoxic (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), vasodilator therapy for pulmonary hypertension (e.g., bosentan). A current dose of less than or equal to 15 mg/day of prednisone or its equivalent is acceptable if the dose is anticipated to remain stable during the study.
Prior use of GB0139 (also called TD139) or previously randomized in GALACTIC-1.
Prior use of nintedanib or pirfenidone within 7 days of initiation of screening.
Prior use of investigational drugs within 30 days (or 5 half-lives, whichever is longer) of initiation of screening.
Participating in another clinical trial, either interventional or observational.
Has a history of unstable or deteriorating cardiac or pulmonary disease (other than

IPF) within the previous six months, including, but not limited to, the following:

Unstable angina pectoris or myocardial infarction, or percutaneous coronary intervention within the last 6 months
Congestive heart failure requiring hospitalization
Uncontrolled clinically significant arrhythmias
If female, the subject is pregnant or lactating or intending to become pregnant before participating in this study during the study and within (5 half- lives plus 30 days) after last dose of the study drug; or intending to donate ova during such time period.
Woman considered to be of childbearing potential who do not use highly effective birth control methods during the study.
Hypersensitivity to the active substance (TD139/GB0139) or the excipient (lactose).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SEC Clinical Research	Andalusia	Alabama	United States	36420-5310
2	Jasper Summit Research, LLC Pulmonary & Sleep Associates	Jasper	Alabama	United States	35501
3	Palmtree Clinical Research Inc	Palm Springs	California	United States	92262-4871
4	Paradigm Research	Redding	California	United States	96001-0172
5	Yale University School of Medicine	New Haven	Connecticut	United States	06520-8057
6	Health Shands Hospital	Gainesville	Florida	United States	32611
7	Harmony Medical Research Institute, Inc	Hialeah	Florida	United States	33016
8	Advanced Research for Health Improvement	Naples	Florida	United States	34109
9	Broward Research Centre	Pembroke Pines	Florida	United States	33024
10	Avanza Medical Research Centre	Pensacola	Florida	United States	32503
11	Coastal Pulmonary Critical Care PLC	Saint Petersburg	Florida	United States	33704
12	Tampa General Hospital/Uni Florida	Tampa	Florida	United States	33606
13	Piedmont Healthcare Pulmonary and Critical Care Research	Atlanta	Georgia	United States	30309
14	The Emory Clinic	Atlanta	Georgia	United States	30322
15	DC Research Works	Marietta	Georgia	United States	30060-7297
16	Northwestern Memorial Hospital	Chicago	Illinois	United States	97232
17	LaPorte County Institute for Clinical Research	Michigan City	Indiana	United States	46360-9330
18	University of Kansas Medical Centre	Kansas City	Kansas	United States	66160
19	University of Louisville Hospital	Louisville	Kentucky	United States	40202
20	University of Maryland	Baltimore	Maryland	United States	21201
21	Harvard Medical School - Brigham and Womens Hospital (BWH)	Boston	Massachusetts	United States	02115
22	The Lung Research Center LLC	Chesterfield	Missouri	United States	63017
23	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03766
24	Pulmonlx LLC	Greensboro	North Carolina	United States	27403
25	University of Cincinnati	Cincinnati	Ohio	United States	45276
26	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44109
27	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
28	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232-2650
29	University of Texas Health Centre at Houston	Houston	Texas	United States	77030
30	University of Texas Health Sciences Center at Houston	Houston	Texas	United States	77030
31	Diagnostics Research Group	San Antonio	Texas	United States	78229
32	University of Utah Health Scieces Center	Salt Lake City	Utah	United States	84108
33	TPMG Clinical Research	Williamsburg	Virginia	United States	23188
34	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
35	Lung Research QLD	Chermside	Queensland	Australia	4032
36	Flinders Medical Centre	Adelaide	South Australia	Australia	5042
37	Respiratory Clinical Trials	Kent Town	South Australia	Australia	5067
38	Institute for Respiratory Health Sir Charles Gairdner Hospital	Nedlands	Western Australia	Australia	6009
39	TrialsWest	Spearwood	Western Australia	Australia	6163
40	Cliniques Universitaires St-Luc	Louvain-la-Neuve	Wallon Region	Belgium	1348
41	UZ Antwerp	Antwerp		Belgium
42	CUB Hopital Erasme	Brussels		Belgium	1400
43	UZ Leuven- Campus Gasthuisberg	Brussels		Belgium	3000
44	CHU UCL Namur site Godinne	Namur		Belgium	5000
45	Firestone Institute for Respiratory Health	Hamilton	Ontario	Canada	L8N 4A6
46	Dr Anees Medicine Professional Corporation	Windsor	Ontario	Canada	N8X 1T3
47	Dr Dhar Medical Practice	Windsor	Ontario	Canada	N8X 5A6
48	Toronto General Hosp Research Inst	Toronto		Canada	M5T 2S8
49	Groupe Hospitalier Hopitaux Universitaires Paris-Seine-Saint-Denis-Hopital Avicenne	Bobigny		France	93000
50	CHRU Lille - Hopital Calmette	Lille		France	59000
51	Hopital Nord de Marseille	Marseille		France	13015
52	APHP - Hopital Europen Georges-Pompidou	Paris		France	75015
53	Hopital Bichat	Paris		France	75877
54	Centre Hospitalier Universitaire de Rennes Hopital Pontchaillou	Rennes		France	35033
55	CHU de la Réunion Site SUD (Terre Sainte)	Saint Pierre		France	97410
56	CHU de la Réunion- Site Félix Guyon	Saint-Pierre		France	97410
57	Hopitaux Universitaires de Strasborg Service de Pneumologie Nouvel Hopital Civil	Strasbourg		France	67091
58	Centre Hospitalier Rgional et Universitaire - Hopital Bretonneau	Tours		France	37044
59	Chapidze Emergency Cardiology Center	Tbilisi		Georgia	0159
60	The First Medical Center	Tbilisi		Georgia	0180
61	Thoraxklinik-Heidelberg gGmbH	Heidelberg	Baden-Württemberg	Germany	69126
62	Lungenfachklinik Immenhausen Department for Clinical Studies	Immenhausen	Hessen	Germany	34376
63	ZMS Zentrum für medizinische Studien GmbH	Warendorf	Rhine-Westphalia	Germany	48231
64	Klifeck GmbH Praxis Med. Gerald Eckhardt	Delitzsch	Sachsen	Germany	04509
65	Studienzentrum Dr.med Falk Brunner FA fuer Innere Medizin und Pneumologie	Leipzig	Saxony	Germany	04157
66	CIMS Studienzentrum Bamberg GmbH	Bamberg		Germany	96049
67	Krankenhaus Donaustauf	Donaustauf		Germany	93093
68	Ruhrlandklinik Essen	Essen		Germany	45239
69	Universitaetsklinikum Leipzig Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, P	Leipzig		Germany	04103
70	POIS Leipzig GbR	Leipzig		Germany	04357
71	Klinikum Grossadern der Ludwig-Maximilians-Universitaet Muenchen	Munich		Germany	81377
72	Trinity Centre for Health Sciences	Dublin		Ireland	D24NROA
73	Hadassah Medical Center	Jerusalem		Israel
74	Meir Medical Center	Kefar Sava		Israel	44281
75	Pulmonary Institute Rabin Medical Center	Petah Tikva		Israel	4941492
76	Sheba Medical Center	Ramat Gan		Israel
77	Kaplan Medical Center	Reẖovot		Israel
78	University-Hospital Policlinico Vittorio Emanuele	Catania		Italy	95123
79	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan		Italy	20122
80	Ospedale San Giuseppe Clinica Malattie dell Apparato Respiratorio	MIlan		Italy	20123
81	University Hospital of Mondena-AOU - Policlinico di Modena	Modena		Italy	41124
82	A.O. Dei Colli OSPEDALE MONALDI	Napoli		Italy	80131
83	Ospedale GB Morgagni	Padova		Italy	35100
84	Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)	Palermo		Italy	90127
85	Azienda Ospedaliera Universitaria Senese	Siena		Italy	53100
86	AOU Città della Salute e della Scienza, PO Molinette	Turin		Italy	10126
87	Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi	Łódź	Lodz	Poland	90-153
88	Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc	Warszawa	Mazovia	Poland	01-138
89	Oddział Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie	Kraków	Małopolskie	Poland	30688
90	Klinika Alergologii Pneumonologii	Gdańsk	Pomerania	Poland	80-214
91	Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu	Poznań		Poland	60-569
92	Hospital Universitario Central de Asturias	Oviedo	Asturias	Spain	33011
93	Hospital Univ. Marques de Valdecilla	Santander	Cantabria	Spain	39008
94	Hospital Universitario Lucas Augusti	Lugo	Galicia	Spain	27003
95	Hospital Universitario Quiron Madrid	Pozuelo De Alarcón	Madrid	Spain	28223
96	Policlinica Barcelona	Barcelona		Spain	08006
97	Hospital Clinic de Barcelona	Barcelona		Spain	08036
98	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08041
99	Hopital de Bellvitge	Barcelona		Spain	08907
100	Hospital Vall d'Hebron	Barcelona		Spain	8035
101	Hospital Clinico San Carlos	Madrid		Spain
102	Hospital General de Valencia	Valencia		Spain	46014
103	Chernivtsi Regional Clinical Hospital	Chernivtsi		Ukraine	58001
104	National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovsky	Kyiv		Ukraine	03038
105	National Research Centre for Radiation Medicine of The National Academy of Medical Sciences of UKR	Kyiv		Ukraine	03115
106	Ternopil Municipal City Hosipital 2	Ternopil		Ukraine	46023
107	Medical Centre Pulse	Vinnytsya		Ukraine	21001
108	Papworth Hospital NHS Foundation Trust	Cambridge	Cambridgeshire	United Kingdom	CB2 0AY
109	Royal Devon and Exeter Hospital	Exeter	Devon	United Kingdom	EX2 5DW
110	Royal Brompton Hospital	London	Greater London	United Kingdom	SW3 6NP
111	Wythenshawe Hospital	Manchester	Greater Manchester	United Kingdom	M23 9LT
112	University Hospital Southampton NHS Foundation Trust	Southampton	Hampshire	United Kingdom	SO16 6YD
113	Glenfield Hospital	Leicester	Leicestershire	United Kingdom	LE3 9QP
114	Aintree Unversity Hospital NHS Foundation Trust	Liverpool	Merseyside	United Kingdom	L9 7AL
115	Newcastle Royal Victoria Infirmary	Newcastle Upon Tyne	Newcastle	United Kingdom	NE1 4LP
116	Nottingham City Hospital	Nottingham	Nottinghamshire	United Kingdom	NG5 1PB
117	Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital (RHH)	Sheffield	South Yorkshire	United Kingdom	S5 7AU
118	Birmingham Heartlands Hospital	Birmingham	West Midlands	United Kingdom	B9 5SS
119	Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital	Bristol		United Kingdom	BS10 5NB
120	Royal Infirmary of Edinburgh	Edinburgh		United Kingdom	EH16 4SA