DDrare: Database of Drug Development for Rare Diseases

85. 特発性間質性肺炎
［臨床試験数：514，薬物数：377（DrugBank：108），標的遺伝子数：97，標的パスウェイ数：204］

Searched query = "Idiopathic interstitial pneumonia", "IIPs", "Idiopathic pulmonary fibrosis", "IPF", "Usual interstitial pneumonia", "UIP", "Non-specific interstitial pneumonia", "NSIP", "Acute interstitial pneumonia", "AIP", "Diffuse alveolar damage", "DAD", "COP", "Organizing pneumonia", "OP", "Desquamative interstitial pneumonia", "DIP", "Respiratory bronchiolitis - associated interstitial lung disease", "RB-ILD", "Lymphocytic interstitial pneumonia", "LIP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = (18)F-FDG; 18F-FDG; 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt; 534-1508; 68Ga-BMV101; ACETYLCYSTEINE; ACT-064992; ACT-064992 (macitentan); ART-123; AZAPRED; Acetate; Acetylcysteine; Acetylcysteine Effervescent Tablets; Adult human mesenchymal stem cells; Aerosol interferon-gamma; Air; Alemtuzumab; Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs); Ambrisentan; Antimicrobial therapy: Co-trimoxazole or Doxycycline; Atezolizumab; Autoantibody Reductive Therapy; Autologous Adipose Derived MSCs (ADMSCs); Autologous Stromal Vascular Fraction (SVF); Autologous mesenchymal stem cells derived from bone marrow; Aviptadil; Aviptadil, 66 microgram/mL; Azathioprine; Azathioprine/prednisone; Azithromycin; BBT-877, Multiple doses; BBT-877, Single dose; BG00011; BI 1015550; BIBF 1120; BIBF 1120 ES; BIBF1120; BLD-2660; BMS-986020; BMS-986278; BOSENTAN; Bardoxolone; Bardoxolone methyl; Beclometasone dipropionate; Bevacizumab; Blood sample collection; Bone marrow mesenchymal stem cells; Bosentan; C21; CBDCA; CC; CC-90001; CC-930; CD3/CD19 negative hematopoietic stem cells; CNC; CNTO 888 1 mg/kg; CNTO 888 15 mg/kg; CNTO 888 5 mg/kg; CNTO888; CO; CO-TRIMOXAZOLE; COMPOUND 21; Carbon; Carbon monoxide; Carboplatin; Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03); Co-trimoxazole; Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids; Corticosteroid (prednisolone); Cotrimoxazole; Cravit; Cromoglicate; Cromoglicato disodico; Cromoglycate; Cromolyn; Cromolyn Sodium; Cromolyn sodio (cromoglicato disodico, DSCG); Cromolyn sodium [Disodium Cromoglycate]; Cyclophosphamide; Cyclosphamine; Cysteine; DEX284; DPA; Dabigatran; Dasatinib; Dasatinib + Quercetin; Device: Auto-titrating oxygen system; Device: Centricyte 1000; Device: MRI; Device: Oxymizer® compared to CNC; Dextromethorphan; Diagnostic Test: Metabolomics; Diagnostic Test: PET Imaging; Disodium Cromoglycate [cromolyn sodium]; Disodium cromoglycate (DSCG); Doxycycline; EGCG; ENDOXAN; ESBRIET; EZ-2053; EZ-2053 5mg/kg; Endobronchial infusion of adult mesenchymal stem cells; Endoxan; Epigallocatechin; Epigallocatechin-3-gallate (EGCG); Erivedge; Esbriet; Esbriet® (Pirfenidon); Etanercept; Etoposide; FG-3019; FG-3019 10mg/mL in 10 mL vials; FLUORINE (18F) FLUDEOXYGLUCOSE; Fludarabine; Fludeoxyglucose; Fluimucil; Fluimucil® 600 mg effervescent tablets; Formoterol; Formoterol fumarate dihydrate; Fostair; G-CSF; G321605; G451990; GBT440; GBT440 300 mg capsule; GBT440 300 mg tablet; GC1008; GKT137831; GLPG1205; GLPG1690; GLPG1690 600 mg QD; GS-6624; GSK2126458; GSK3008348; GSK3008348 Nebuliser solution; Gallium68-Dota-Noc; Gefapixant; Granulocyte Colony Stimulating Factor; HEC 68498; HEC585; High dose BIBF 1120 twice daily; Humanized anti-alpha v beta 6 mAb; Hydroxyurea; Hyperoxia; Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment; Hyperpolarized 129-Xenon gas; IDL-2965 Oral Capsule; INO; INOmax; INOmax 400ppm mol/mol inhalation gas; IW001; Ifenprodil; Iloprost; Iloprost Inhalation Solution (Ventavis); Imatinib; Imatinib Mesylate (Gleevec); Immukin; Inhaled Nitric Oxide; Inhaled Nitric Oxide - 30 mcg/kg IBW/hr; Inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr; Inhaled TD139; Inhaled carbon monoxide; Inhaled nitric oxide 75 mcg/kg IBW/hr; Inomax; Interferon Gamma; Interferon alpha oral lozenge; Interferon gamma-1b; Interferon gamma-1b (Actimmune); Interferon-alpha lozenges; Interferon-gamma 1b; Intermediate dose BIBF 1120 twice daily; Jaktinib Dihydrochloride Monohydrate 50mg BID and Mimic tablets of jakitinib hydrochloride 75mg BID and Acetylcysteine Effervescent Tablets; Jaktinib Dihydrochloride Monohydrate 75mg BID and Mimic tablets of jakitinib hydrochloride 50mg BID and Acetylcysteine Effervescent Tablets; Jin-shui Huan-xian granule; KD025; L - Antineoplastic and immunomodulating agents; L01 - Antineoplastic agents; L01X - Other antineoplastic agents; L01XE - Protein kinase inhibitors; L01XE31; L01XE31 - Nintedanib; LANREOTIDE ACETATE; LEBRIKIZUMAB; LPA1; Lanreotide; Lansoprazole; Lebrikizumab; Letairis; Letairis 10 mg; Letairis 5 mg; Liberase Enzyme (Roche); Losartan; Low dose BIBF 1120 twice daily; Low dose BIBF1120 once daily; Lung Spheroid Stem Cells 100 million; Lung Spheroid Stem Cells 200 million; Lung stem cells; MACITENTAN; MESNA; MG-S-2525; MONITOR; Macitentan; Medical air; Medical air (sham O2); Mesna; Minocycline; Montelukast; Morphine; Morphine Sulfate; Morphine hydrochloride; Morphine sulfate; Moxifloxacin; Mycophenolate; Mycophenolate mofetil; N-Acetylcysteine, (NAC); N-acetyl cysteine; N-acetylcysteine; NAC; NALBUPHINE HYDROCHLORIDE; ND-L02-s0201; ND-L02-s0201 for injection; NINTEDANIB; NITRIC OXIDE; Na; Nalbuphine; Nalbuphine ER; Nalbuphine Extended-Realease (ER) Tablets; Nalbuphine Extended-Release (ER) Tablets; Nandrolone; Nandrolone Decanoate; Nandrolone decanoate; Nintedanib; Nitric Oxide; Nivolumab; None; OFEV®; ORIN1001; Octreotide; Ofev; Ofev 100 mg capsule; Ofev 150 mg capsule; Omeprazole; Omeprazole (UK licensed generic product); Other: 60% Oxygen; Other: Control; Other: Cough monitor; Other: Medical air; Other: No Intervention: Standard of Care; Other: Oxygen; Other: Oxygen (2Liter/min); Other: Oxygen (4Liter/min); Other: Pulmonary rehabilitation program; Other: Standard of Care; Other: Untreated Cohort; Oxygen; Oxygen 40 %; PA101; PAMREVLUMAB; PBI4050; PD00377 Na-salt; PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714; PIR, S-7701; PIRFENIDONE; PLN-74809; PLN-74809-000; PREDNISOLONE; PRIVIGEN 100mg/ml; PRM-151; PZN 8881655(RochePharma AG); Paclitaxel; Pamrevlumab; Pirfenidone; Pirfenidone and nintedanib; Pirfenidone or nintedanib; Pirfenidoneone; Placebo; Pomalidomide; Pomalidomide (CC-4047; Prednisolone; Prednisone; Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution; Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF); QAX576; Quercetin; RIXATHON 500 mg; RO0220912; RO0280296; RO5490255; RO5490255/F01-02; RVT-1601; RVT-1601 (formerly, PA101B); Radiation: FDG PET scan; Radiation: GSK26346763: ([18F]-FBA-A20FMDV2) IV infusion; Radiation: Knottin tracer; Remicade; Revatio; Revatio 20 mg; Rituximab; Ro 47-0203; SAR156597; SEPTRIN; SILDENAFIL; SM04646; SODIUM CROMOGLICATE; SULFAMETHOXAZOLE; Salbutamol; Saracatinab; Septrin; Sildenafil; Sildenafil (50 mg); Sildenafil Citrate; Sildenafil and Losartan; Simtuzumab; Sirolimus; Sivelestat; Standard Steroid Treatment; Standard of Care; Sterile Normal Saline for Intravenous Use; Sub-Study: Nintedanib; Sub-Study: Pirfenidone; Sulfamethoxazole; Sulfate; Sulphamethoxazole; Symbicort; TBC; TD-1058; TD139; TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A; TR0311; TRACLEER; TRIMETHOPRIM; TRK-250; Tacrolimus; Tetrandrine; Tetrathiomolybdate; Thalidomide; Thalidomide Pharmion; The Standard Steroid Treatment, Plasma Exchange and rituximab; Thiotepa; Thrombomodulin Alfa; Thrombomodulin alfa; Tiotropium; Tipelukast; Tracleer; Traditional Chinese Medicine Formulation; Tralokinumab; Tralokinumab cohort 1; Tralokinumab cohort 2; Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor; Treatment as Usual (TAU); Treprostinil; Treprostinil sodium for inhalation; Trimethoprim; UROMITEXAN; Uromitexan; VAY736; VISMODEGIB; VOLIBRIS; VRP700; Valganciclovir; Vasoactive intestinal peptide; Vismodegib; Volibris; Warfarin; Xenon; ZL-2102; ZSP1603 12.5 mg; ZSP1603 25 mg; ZSP1603 50 mg; ZSP1603 7.5 mg; Zileuton; Ziritaxestat; [18F]-FBA-A20FMDV2; [18F]FP-R01-MG-F2; [68Ga]CBP8; [BG00011]; [RVT-1601 (in precedenza PA101B)]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2019-004167-45-SK (EUCTR)	02/11/2020	11/08/2020	A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).	A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally.	Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	United States;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;United Kingdom;Italy;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Czechia
2	EUCTR2019-004167-45-DK (EUCTR)	27/08/2020	12/06/2020	A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).	A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 18 mg taken orally.	Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550	Boehringer Ingelheim B.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	Spain;Ukraine;Chile;Russian Federation;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan;Slovakia;Greece;United States
3	EUCTR2019-004167-45-PL (EUCTR)	24/08/2020	14/07/2020	A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).	A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally.	Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	United States;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
4	EUCTR2019-004167-45-GB (EUCTR)	19/08/2020	24/06/2020	A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).	A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally.	Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550	Boehringer Ingelheim Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	United States;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
5	EUCTR2019-004167-45-HU (EUCTR)	17/08/2020	24/06/2020	A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).	A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 18 mg taken orally b.i.d.	Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	United States;Greece;Finland;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2019-004167-45-DE (EUCTR)	30/07/2020	22/06/2020	A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).	A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally.	Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	United States;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
7	NCT04419506 (ClinicalTrials.gov)	July 28, 2020	4/6/2020	A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)	A Randomised, Double-blind, Placebo-controlled Parallel Group Study in IPF Patients Over 12 Weeks Evaluating Efficacy, Safety and Tolerability of BI 1015550 Taken Orally	Idiopathic Pulmonary Fibrosis	Drug: BI 1015550;Drug: Placebo	Boehringer Ingelheim	NULL	Recruiting	40 Years	N/A	All	150	Phase 2	United States;Canada;Denmark;Finland;Germany;Japan;Korea, Republic of;Netherlands;Spain
8	EUCTR2019-004167-45-NL (EUCTR)	09/07/2020	12/05/2020	A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).	A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 18 mg taken orally b.i.d.	Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550	Boehringer Ingelheim	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	United States;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan
9	EUCTR2019-004167-45-FI (EUCTR)	18/05/2020	15/04/2020	A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).	A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally.	Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550	Boehringer Ingelheim Finland Ky	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	United States;Czechia;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;United Kingdom;Italy;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
10	NCT03422068 (ClinicalTrials.gov)	March 16, 2018	22/1/2018	This Study Tests Different Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF). The Study Tests How BI 1015550 is Taken up by the Body and How Well it is Tolerated.	Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF) on no Background Anti-fibrotic Therapy.	Idiopathic Pulmonary Fibrosis	Drug: BI 1015550;Drug: Placebo	Boehringer Ingelheim	NULL	Completed	40 Years	N/A	All	15	Phase 1	Belgium;Denmark;Finland;Germany;Italy;Netherlands;Spain;United Kingdom;France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-004167-45-SK
(EUCTR)

02/11/2020

11/08/2020

A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).

A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally.

Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550

Boehringer Ingelheim RCV GmbH & Co KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

United States;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;United Kingdom;Italy;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Czechia

EUCTR2019-004167-45-DK
(EUCTR)

27/08/2020

12/06/2020

A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).

A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 18 mg taken orally.

Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550

Boehringer Ingelheim B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Spain;Ukraine;Chile;Russian Federation;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan;Slovakia;Greece;United States

EUCTR2019-004167-45-PL
(EUCTR)

24/08/2020

14/07/2020

A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).

A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally.

Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550

Boehringer Ingelheim RCV GmbH & Co KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

United States;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of

EUCTR2019-004167-45-GB
(EUCTR)

19/08/2020

24/06/2020

A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).

A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally.

Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550

Boehringer Ingelheim Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

United States;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of

EUCTR2019-004167-45-HU
(EUCTR)

17/08/2020

24/06/2020

A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).

A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 18 mg taken orally b.i.d.

Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550

Boehringer Ingelheim RCV GmbH & Co KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

United States;Greece;Finland;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-004167-45-DE
(EUCTR)

30/07/2020

22/06/2020

A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).

A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally.

Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550

Boehringer Ingelheim Pharma GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

United States;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of

NCT04419506
(ClinicalTrials.gov)

July 28, 2020

4/6/2020

A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

A Randomised, Double-blind, Placebo-controlled Parallel Group Study in IPF Patients Over 12 Weeks Evaluating Efficacy, Safety and Tolerability of BI 1015550 Taken Orally

Idiopathic Pulmonary Fibrosis

Drug: BI 1015550;Drug: Placebo

Boehringer Ingelheim

NULL

Recruiting

40 Years

N/A

All

150

Phase 2

United States;Canada;Denmark;Finland;Germany;Japan;Korea, Republic of;Netherlands;Spain

EUCTR2019-004167-45-NL
(EUCTR)

09/07/2020

12/05/2020

A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).

A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 18 mg taken orally b.i.d.

Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550

Boehringer Ingelheim

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

United States;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan

EUCTR2019-004167-45-FI
(EUCTR)

18/05/2020

15/04/2020

A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).

A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally.

Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550

Boehringer Ingelheim Finland Ky

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

United States;Czechia;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;United Kingdom;Italy;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of

NCT03422068
(ClinicalTrials.gov)

March 16, 2018

22/1/2018

This Study Tests Different Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF). The Study Tests How BI 1015550 is Taken up by the Body and How Well it is Tolerated.

Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF) on no Background Anti-fibrotic Therapy.

Idiopathic Pulmonary Fibrosis

Drug: BI 1015550;Drug: Placebo

Boehringer Ingelheim

NULL

Completed

40 Years

N/A

All

Phase 1

Belgium;Denmark;Finland;Germany;Italy;Netherlands;Spain;United Kingdom;France