DDrare: Database of Drug Development for Rare Diseases

Searched query = "Primary biliary cholangitis", "Primary biliary cirrhosis", "PBC"
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 = 1-20190; 11C-CSar; 13-15mg/kg/d Ursodeoxycholic; 18-22mg/kg/d Ursodeoxycholic; 3 mg [14C]-A4250 capsule; 3a,7a-dihydroxy-6a-ethyl-5betacholan-24-oic acid; 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid; 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747; 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747; 6-ECDCA; 6-ethylchenodeoxycholic acid; 6?-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747; 6?-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747; 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747; 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747; 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid; 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5betacholan-24-o; 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5betacholan-24-o, obeticholic acid (OCA); 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o; 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o, obeticholic acid (OCA); 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid; 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5betacholan-24-o; 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5betacholan-24-o , obeticholic acid (OCA); 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o; 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o , obeticholic acid (OCA); A11HA02; A4250; APD334; Abatacept; Acido Obeticolico; Acido ursodessicolico; Alkaline Phosphatase; Atorvastatin; BARICITINIB; BCD-085; BEZAFIBRATE; BUDESONIDE; Baricitinib; Bezafibrat; Bezafibrat Genericon retard 400 mg; Bezafibrate; Bezafibrate 200 MG; Bezafibrate 400 MG; Bezafibrate IR; Bezafibrate SR; Bezafibrate, Beza, BZF, Bezalip; Bezafibrate, Beza, BZF, Bezalip mono; Bezalip; Bezalip mono; Biological: mesenchymal stem cell; Budenofalk 3mg; Budesonide; CNTO1275; CR845 1.0 mg; CRC (A3384); Calcium; Choline; Cilofexor; Colchicine; Combination antiviral therapy; Cyclophosphamide; Cyclosporin; Cyclosporin A; Denosumab; Device: Fibroscan; E6011; EDP-305; EDP-305 Dose 1; EDP-305 Dose 2; ELAFIBRANOR; EZETIMIBE; EZT; Elafibranor; Elafibranor 120 mg; Elafibranor 80 mg; Elafibranor 80mg; Emtricitabine; Emtricitabine (FTC)/Tenofovir Disoproxil (TDF); Experimental: Seladelpar / MBX-8025 200 mg; Experimental: Seladelpar / MBX-8025 50 mg; Ezetimibe; Ezetrol; FFP104; Fenofibrate; Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle); Fully human monoclonal antibody directed against CXCL10; Fuzhenghuayu; GFT505; GKT137831; GS-9674; GS-9674 100 mg; GS-9674 30 mg; GSK2330672; Gold; HTD1801 (BUDCA); High protein high fiber diet; ICG; INT-747; INT-747, OCA; Kaletra; LJN452; LJN452, 0,01 mg; LJN452, 0,03 mg; LJN452, 0,1 mg; LUM001; LY3009104; Linerixibat; Linerixibat (GSK2330672) 45mg; Liver biopsy; MBX 8025; MBX-8025; MBX-8025 10 mg Capsule; MBX-8025 2 mg Capsule; MBX-8025 5 mg Capsule; MBX-8025, DSIC; MBX-8025, Formulation 2; MabThera; MabThera®; Magnesium; Methionine; Methotrexate; Minodronic acid; Modafinil; Moexipril; Mycophenolate; Mycophenolate Mofetil; Mycophenolate mofetil; NGM282; NI-0801; Non-myeloablative Hematopoietic Stem Cell Transplantation; OCA (INT-747); OCA, INT-747; OP-724; Obeticholic Acid; Obeticholic Acid (OCA); Obeticholic acid; Obeticholic acid (OCA); Ocaliva; Ocaliva 10mg; Ocaliva 5mg; Olumiant; Other: Blood samples; Other: Questionnaires; PYRIDOXINE; Part 1: LJN452; Part 2: LJN452 Dose level 1; Part 2: LJN452 Dose level 2; Pemafibrate; Pentoxifylline; Phenylbutyrate; Prednisone; Probiotic; Pyridoxine; Pyridoxine 10mg; Pyridoxine 10mg BP; Questran; Raltegravir; RhuDex 100 mg (127 mg RhuDex choline salt) granules; RhuDex 25 mg (31.75 mg RhuDex choline salt) granules; RhuDex 50 mg (63.5 mg RhuDex choline salt) granules; RhuDex choline salt; Rifampicin; Risedronic acid; Rituximab; S-adenosyl-L-methionine; S-adenosyl-methionine (SAMe) capsules; SAMe; SELADELPAR; Saroglitazar; Saroglitazar magnesium 2 mg; Saroglitazar magnesium 4 mg; Seladelpar; Seladelpar 10 mg; Seladelpar 10 mg Capsule; Seladelpar 5 mg; Seladelpar 5 mg Capsule; Seladelpar 5-10 mg; Sortis; Sortis 10 mg; Sublimated mare milk; TQA3526; Tauroursodeoxycholic Acid Capsules; Tauroursodeoxycholic acid; Tenofovir; Tenofovir disoproxil; Tetrathiomolybdate; Tigecycline; Tropifexor; Truvada and Kaletra; UDCA; UDCA (Ursodeoxycholic acid); URSODEOXYCHOLIC ACID; Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation; Ursodeoxycholic Acid; Ursodeoxycholic Acid (URSO); Ursodeoxycholic Acid 300mg capsule; Ursodeoxycholic Acid 300mg tablet; Ursodeoxycholic Acid Capsules; Ursodeoxycholic acid; Ursodeoxycholic acid combination of immunosuppressive agents; Ursodeoxycholic acid combined with total glucosides of paeony; Ursodeoxycholic acid only; Ursodeoxycholic acid+Low Dose Glucocorticoid(prednisone); Ursodeoxycholsäure; Ursodiol; Ursofalk; Ursofalk® 500 mg Filmtabletten; Ursofalk® 500 mg film-coated tablets; Ursofalk® capsules; Ustekinumab; Ustekinumab 180 mg; Ustekinumab 45 mg; Ustekinumab 90 mg; Vitamin D; Zoledronic acid

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	NCT04620733 (ClinicalTrials.gov)	January 2021	4/11/2020	RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)	RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)	Primary Biliary Cholangitis	Drug: Seladelpar 10 mg;Drug: Placebo;Drug: Seladelpar 5 mg	CymaBay Therapeutics, Inc.	NULL	Not yet recruiting	18 Years	75 Years	All	180	Phase 3	NULL
2	EUCTR2018-001171-20-AT (EUCTR)	29/04/2019	19/10/2018	A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		CymaBay Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
3	EUCTR2018-001171-20-NL (EUCTR)	18/04/2019	16/11/2018	A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR	CymaBay Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	United States;Serbia;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
4	EUCTR2018-001171-20-BE (EUCTR)	06/03/2019	29/01/2019	A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		CymaBay Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
5	EUCTR2018-001171-20-FR (EUCTR)	23/01/2019	18/10/2018	A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		CymaBay Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;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	EUCTR2018-001171-20-PL (EUCTR)	27/12/2018	06/11/2018	A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR	CymaBay Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	United States;Serbia;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
7	EUCTR2018-001171-20-ES (EUCTR)	21/12/2018	18/01/2019	A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		CymaBay Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of
8	EUCTR2018-001171-20-DE (EUCTR)	20/12/2018	18/10/2018	A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		CymaBay Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
9	EUCTR2018-001171-20-HU (EUCTR)	26/11/2018	18/10/2018	A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		CymaBay Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of
10	NCT03602560 (ClinicalTrials.gov)	November 26, 2018	18/7/2018	ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)	A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)	Primary Biliary Cholangitis	Drug: seladelpar 5-10 mg;Drug: seladelpar 10 mg;Drug: Placebo	CymaBay Therapeutics, Inc.	NULL	Suspended	18 Years	75 Years	All	240	Phase 3	United States;Argentina;Australia;Austria;Belgium;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Spain;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
11	EUCTR2018-001171-20-GR (EUCTR)	23/11/2018	18/10/2018	A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).	Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		CymaBay Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of
12	EUCTR2017-003910-16-GB (EUCTR)	08/02/2018	15/11/2017	A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis	An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)	Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Seladelpar Product Code: MBX-8025 , DSIC INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 , DSIC INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 , Formulation 2 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 , Formulation 2 INN or Proposed INN: SELADELPAR	CymaBay Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3;Phase 4	Serbia;United States;Greece;Spain;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
13	EUCTR2017-003910-16-DE (EUCTR)	29/01/2018	04/12/2017	A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis	An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)	Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Body processes [G] - Immune system processes [G12]		CymaBay Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	128	Phase 2;Phase 3	United States;Canada;Germany;United Kingdom
14	NCT03301506 (ClinicalTrials.gov)	December 12, 2017	26/9/2017	Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)	ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)	Primary Biliary Cirrhosis	Drug: Seladelpar 5 mg Capsule;Drug: Seladelpar 10 mg Capsule	CymaBay Therapeutics, Inc.	NULL	Active, not recruiting	18 Years	75 Years	All	500	Phase 3	United States;Canada;Germany;United Kingdom
15	NCT02955602 (ClinicalTrials.gov)	November 28, 2016	2/11/2016	Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)	An 8-week, Dose Ranging, Open Label, Randomized, Phase 2 Study With a 44-week Extension, to Evaluate the Safety and Efficacy of MBX-8025 in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or Intolerance to Ursodeoxycholic Acid (UDCA)	Primary Biliary Cirrhosis	Drug: MBX-8025 2 mg Capsule;Drug: MBX-8025 5 mg Capsule;Drug: MBX-8025 10 mg Capsule	CymaBay Therapeutics, Inc.	NULL	Completed	18 Years	75 Years	All	119	Phase 2	United States;Canada;Germany;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
16	NCT02609048 (ClinicalTrials.gov)	November 2015	13/11/2015	Study to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC)	A 12-week, Double-blind, Randomized, Placebo-controlled, Phase 2 Study, to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA)	Primary Biliary Cirrhosis (PBC)	Drug: Placebo Comparator;Drug: Experimental: Seladelpar / MBX-8025 50 mg;Drug: Experimental: Seladelpar / MBX-8025 200 mg	CymaBay Therapeutics, Inc.	NULL	Terminated	18 Years	75 Years	All	41	Phase 2	United States;Canada;Germany;Poland;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

NCT04620733
(ClinicalTrials.gov)

January 2021

4/11/2020

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Primary Biliary Cholangitis

Drug: Seladelpar 10 mg;Drug: Placebo;Drug: Seladelpar 5 mg

CymaBay Therapeutics, Inc.

NULL

Not yet recruiting

18 Years

75 Years

All

180

Phase 3

NULL

EUCTR2018-001171-20-AT
(EUCTR)

29/04/2019

19/10/2018

A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).

A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).

Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

CymaBay Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of

EUCTR2018-001171-20-NL
(EUCTR)

18/04/2019

16/11/2018

A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).

Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR

CymaBay Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

United States;Serbia;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of

EUCTR2018-001171-20-BE
(EUCTR)

06/03/2019

29/01/2019

A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).

CymaBay Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

EUCTR2018-001171-20-FR
(EUCTR)

23/01/2019

18/10/2018

A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).

CymaBay Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;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

EUCTR2018-001171-20-PL
(EUCTR)

27/12/2018

06/11/2018

A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).

Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR

CymaBay Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

EUCTR2018-001171-20-ES
(EUCTR)

21/12/2018

18/01/2019

A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).

CymaBay Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of

EUCTR2018-001171-20-DE
(EUCTR)

20/12/2018

18/10/2018

A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).

CymaBay Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

EUCTR2018-001171-20-HU
(EUCTR)

26/11/2018

18/10/2018

A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).

CymaBay Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of

NCT03602560
(ClinicalTrials.gov)

November 26, 2018

18/7/2018

ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Primary Biliary Cholangitis

Drug: seladelpar 5-10 mg;Drug: seladelpar 10 mg;Drug: Placebo

CymaBay Therapeutics, Inc.

NULL

Suspended

18 Years

75 Years

All

240

Phase 3

United States;Argentina;Australia;Austria;Belgium;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Spain;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

EUCTR2018-001171-20-GR
(EUCTR)

23/11/2018

18/10/2018

A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).

CymaBay Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of

EUCTR2017-003910-16-GB
(EUCTR)

08/02/2018

15/11/2017

A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: Seladelpar
Product Code: MBX-8025 , DSIC
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025 , DSIC
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025 , Formulation 2
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025 , Formulation 2
INN or Proposed INN: SELADELPAR

CymaBay Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3;Phase 4

Serbia;United States;Greece;Spain;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of

EUCTR2017-003910-16-DE
(EUCTR)

29/01/2018

04/12/2017

A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Body processes [G] - Immune system processes [G12]

CymaBay Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

128

Phase 2;Phase 3

United States;Canada;Germany;United Kingdom

NCT03301506
(ClinicalTrials.gov)

December 12, 2017

26/9/2017

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

Primary Biliary Cirrhosis

Drug: Seladelpar 5 mg Capsule;Drug: Seladelpar 10 mg Capsule

CymaBay Therapeutics, Inc.

NULL

Active, not recruiting

18 Years

75 Years

All

500

Phase 3

United States;Canada;Germany;United Kingdom

NCT02955602
(ClinicalTrials.gov)

November 28, 2016

2/11/2016

Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)

An 8-week, Dose Ranging, Open Label, Randomized, Phase 2 Study With a 44-week Extension, to Evaluate the Safety and Efficacy of MBX-8025 in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or Intolerance to Ursodeoxycholic Acid (UDCA)

Primary Biliary Cirrhosis

Drug: MBX-8025 2 mg Capsule;Drug: MBX-8025 5 mg Capsule;Drug: MBX-8025 10 mg Capsule

CymaBay Therapeutics, Inc.

NULL

Completed

18 Years

75 Years

All

119

Phase 2

United States;Canada;Germany;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

NCT02609048
(ClinicalTrials.gov)

November 2015

13/11/2015

Study to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC)

A 12-week, Double-blind, Randomized, Placebo-controlled, Phase 2 Study, to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA)

Primary Biliary Cirrhosis (PBC)

Drug: Placebo Comparator;Drug: Experimental: Seladelpar / MBX-8025 50 mg;Drug: Experimental: Seladelpar / MBX-8025 200 mg

CymaBay Therapeutics, Inc.

NULL

Terminated

18 Years

75 Years

All

Phase 2

United States;Canada;Germany;Poland;United Kingdom