DDrare: Database of Drug Development for Rare Diseases

94. 原発性硬化性胆管炎
［臨床試験数：134，薬物数：105（DrugBank：37），標的遺伝子数：18，標的パスウェイ数：131］

Searched query = "Primary sclerosing cholangitis", "PSC"
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 = 11C-CSar; 3108006977; ACETYLCYSTEINE; ACIDO OBETICOLICO; ATRA; AZT; Acetylcysteine; All-trans retinoic acid; Azathioprine; BEFIZAL L.P. 400 mg, comprimé enrobé à libération prolongée; BEZAFIBRATE; BTT1023; BTT1023 IV Infusion 20 mg/mL, 5 mL Drug Product; Befizal; Bezafibrate; Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy; Bezalip; Budesonide; C10AB02; CILO; CM-101; Calcium; Capecitabine; Cenicriviroc; Cenicriviroc 150 mg; Cilofexor; Cis-4-Hydroxy-L-Proline; Cladribine; Curcumin; DHA; DUR-928; Docosahexaenoic Acid (DHA); Docosahexaenoic acid; Engineered recombinant human FGF19; Entyvio; Erlotinib; Erlotinib (Tarceva); FLUIMUCIL*20CPR EFF 600MG; Fecal Microbiota Transplantation; Fenofibrate; Fluimucil; GS-6624; GS-9674; Gluten-free diet; HTD1801; Humanised IgG1 monoclonal antibody against human eotaxin-2; Hymecromone; ICG; INT-747, OCA; LUM001; MBX-8025; MLN0002; Metronidazole; Minocycline; Mitomycin; Mitomycin C; Mizoribine; NGM282; NorUDCA; NorUrsodeoxycholic Acid; NorUrsodeoxycholic acid; Normal saline; Norursodeoxycholic acid; OCA; OCA 1,5 mg; OCA 5 mg; Oral Vancomycin; Oral all-trans retinoic acid (ATRA); Orbcel-C; PLN-74809; Phenylbutyrate; Probiotics; Procedure: Liver transplantation; Procedure: Pre liver transplantation laparoscopic hand assisted staging; Proline; Radiation: 45 Gy external radiations; Radiation: Endoluminal bile duct Brachytherapy; Rec-h-FGF19; Retinoic acid; Rituximab; SELADELPAR; Seladelpar; Simtuzimab; Simtuzumab; Simvastatin; Simvastatin 40mg; Sulfasalazine; TBC; Thalidomide; UCMSC; UDCA; Ursodeoxycholic Acid; Ursodeoxycholic acid; Ursodeoxycholic acid (UDCA); Ursofalk; Ursolic acid; VEDOLIZUMAB; Vancomycin; Vedolizumab; Vedolizumab IV; Vidofludimus; Vidofludimus calcium; Volixibat; Xifaxan; [18F]FP-R01-MG-F2

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	NCT04595825 (ClinicalTrials.gov)	October 1, 2020	7/10/2020	CM-101 in PSC Patients -The SPRING Study	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating The Safety And Efficacy Of CM-101 In Subjects With Primary Sclerosing Cholangitis- The SPRING Study	Primary Sclerosing Cholangitis	Biological: CM-101;Other: Placebo	ChemomAb Ltd.	NULL	Recruiting	18 Years	75 Years	All	45	Phase 2	Israel;United Kingdom
2	EUCTR2019-002945-39-GB (EUCTR)	15/04/2020	14/11/2019	A study to look at how well study drug CM-101 works in people with disease of the liver and gallbladder characterized by inflammation and scarring of the bile ducts	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects with Primary Sclerosing Cholangitis - The SPRING study	Primary Sclerosing Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CM-101 Product Code: CM-101 INN or Proposed INN: TBC Other descriptive name: Humanised IgG1 monoclonal antibody against human eotaxin-2	ChemomAb Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	45	Phase 2	Israel;United Kingdom
3	EUCTR2018-004258-77-GB (EUCTR)	05/02/2019	26/11/2018	A phase 2 study being run in multiple centres to evaluate the safety, tolerability and efficacy of a study drug (called CM-101) which will be given to patients with primary sclerosing cholangitis for 12 weeks.	A Phase 2, Open Label, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of CM-101 Administered for 12 Weeks in Adult Subjects with Primary Sclerosing Cholangitis. - The SPRING Study	Treatment of Primary Sclerosing Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemomAb Ltd.	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	Israel;United Kingdom

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

NCT04595825
(ClinicalTrials.gov)

October 1, 2020

7/10/2020

CM-101 in PSC Patients -The SPRING Study

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating The Safety And Efficacy Of CM-101 In Subjects With Primary Sclerosing Cholangitis- The SPRING Study

Primary Sclerosing Cholangitis

Biological: CM-101;Other: Placebo

ChemomAb Ltd.

NULL

Recruiting

18 Years

75 Years

All

Phase 2

Israel;United Kingdom

EUCTR2019-002945-39-GB
(EUCTR)

15/04/2020

14/11/2019

A study to look at how well study drug CM-101 works in people with disease of the liver and gallbladder characterized by inflammation and scarring of the bile ducts

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects with Primary Sclerosing Cholangitis - The SPRING study

Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: CM-101
Product Code: CM-101
INN or Proposed INN: TBC
Other descriptive name: Humanised IgG1 monoclonal antibody against human eotaxin-2

ChemomAb Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Israel;United Kingdom

EUCTR2018-004258-77-GB
(EUCTR)

05/02/2019

26/11/2018

A phase 2 study being run in multiple centres to evaluate the safety, tolerability and efficacy of a study drug (called CM-101) which will be given to patients with primary sclerosing cholangitis for 12 weeks.

A Phase 2, Open Label, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of CM-101 Administered for 12 Weeks in Adult Subjects with Primary Sclerosing Cholangitis. - The SPRING Study

Treatment of Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

ChemomAb Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Israel;United Kingdom