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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 29 July 2024
Main ID:  EUCTR2020-005198-29-HU
Date of registration: 21/03/2021
Prospective Registration: Yes
Primary sponsor: CymaBay Therapeutics, Inc.
Public title: A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis
Scientific title: ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) - ASSURE
Date of first enrolment: 06/05/2021
Target sample size: 500
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005198-29
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): yes
Countries of recruitment
Argentina Australia Austria Belgium Canada Chile Czech Republic France
Germany Greece Hungary Israel Italy Korea, Republic of Mexico Netherlands
New Zealand Poland Romania Russian Federation Spain United Kingdom United States
Contacts
Contact type: Public
Name: Stacy Meluskey   
Address:  7575 Gateway Blvd. Suite 110 CA 94560 Newark United States
Telephone: +15102938141
Email: smeluskey@cymabay.com
Affiliation:  CymaBay Therapeutics, Inc.
Contact type: Scientific
Name: Stacy Meluskey   
Address:  7575 Gateway Blvd. Suite 110 CA 94560 Newark United States
Telephone: +15102938141
Email: smeluskey@cymabay.com
Affiliation:  CymaBay Therapeutics, Inc.
Key inclusion & exclusion criteria
Inclusion criteria:
1. Must have given informed consent (signed and dated)
2. Participated in a previous PBC study with seladelpar (including CB8025-21629, CB8025-31735, or CB8025-21838) or future PBC studies with seladelpar that allow rollover into CB8025-31731-RE, or were previously enrolled in study CB8025-31731 prior to the early termination of the study, and meet eligibility criteria for the current study.
3. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 428
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 72

Exclusion criteria:
Exclusion criteria are only applicable for subjects with a study drug interruption greater than 4 weeks prior to Day 1 of this study and for subjects who participated in CB8025-21838 irrespective of seladelpar interruption
1. Treatment-related AE leading to study drug discontinuation in a previous PBC study with seladelpar
2. A medical condition, other than PBC, that in the Investigator’s opinion would preclude full participation in the study or confound its results (e.g., cancer)
3. AST or ALT above 3 × ULN
4. Total bilirubin above 2 × ULN
5. Model for End-Stage Liver Disease (MELD) score = 15
6. Evidence of advanced PBC as defined by the Rotterdam criteria (albumin below 1 × lower limit of normal AND total bilirubin above 1 × ULN)
7. Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2 (calculated by Modification of Diet in Renal Disease formula)
8. Auto-immune hepatitis
9. Primary sclerosing cholangitis
10. Known history of alpha-1-antitrypsin deficiency
11. Known history of chronic viral hepatitis
12. For females, pregnancy or breast-feeding
13. Use of colchicine, methotrexate, azathioprine or long-term use of systemic steroids (e.g. prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to Screening
14. Current use of fibrates or use of fibrates within 3 months prior to Screening
15. Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
16. Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
17. History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening
18. Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
19. Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study as judged by the Investigator


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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]
Intervention(s)

Product Name: Seladelpar
Product Code: MBX-8025
Pharmaceutical Form: Capsule
INN or Proposed INN: SELADELPAR
CAS Number: 928821-40-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Product Name: Seladelpar
Product Code: MBX-8025
Pharmaceutical Form: Capsule
INN or Proposed INN: SELADELPAR
CAS Number: 928821-40-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)
Secondary Objective: To evaluate the long-term efficacy of seladelpar, and the effect of seladelpar on patient-reported outcomes (pruritus)
Main Objective: To evaluate the long-term safety and tolerability of seladelpar
Timepoint(s) of evaluation of this end point: Throughout the study
Primary end point(s): Treatment-emergent AEs (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0), biochemistry and hematology results are collected
Secondary Outcome(s)
Secondary end point(s): 1. Occurrence of the following adjudicated PBC clinical outcomes:
-Overall death
-Liver transplantation
-MELD score = 15 for at least 2 consecutive visits
-Ascites requiring treatment
-Hospitalization for new onset or recurrence, of any:
-Variceal bleeding, Hepatic encephalopathy (as defined by a West Haven score = 2), Spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis)
2. Biochemical markers:
-Response on composite of ALP and total bilirubin
-Proportion of subjects with normalization of ALP
-Relative and absolute changes of the following:
-Alkaline phosphatase (ALP)
-Aspartate aminotransferase (AST)
-Alanine aminotransferase (ALT)
-Gamma-glutamyl transferase (GGT)
-Bilirubin (total, direct, indirect)
3. Change from Baseline in pruritus NRS
Timepoint(s) of evaluation of this end point: Throughout the study
Secondary ID(s)
CB8025-31731-RE
2020-005198-29-DE
NCT03301506
Source(s) of Monetary Support
CymaBay Therapeutics, Inc.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 20/04/2021
Contact name:
Contact address:
Contact telephone:
Contact email:
Results
Results available:
URL:
URL of the protocol:
Date Posted:
Date of completion:
Date of first publication:
Results summary:
Baseline characteristics: No results available
Adverse events: No results available
Outcome measures: No results available
IPD sharing plan:
IPD sharing description:
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