Main
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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:
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EUCTR |
Last refreshed on:
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29 July 2024 |
Main ID: |
EUCTR2020-005198-29-HU |
Date of registration:
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21/03/2021 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study to evaluate the safety and tolerability of seladelpar in subjects
with primary biliary cholangitis
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Scientific title:
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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:
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06/05/2021 |
Target sample size:
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500 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005198-29 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Canada
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Chile
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Czech Republic
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France
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Germany
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Greece
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Hungary
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Israel
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Italy
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Korea, Republic of
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Mexico
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Netherlands
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New Zealand
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Poland
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Romania
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Russian Federation
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Spain
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United Kingdom
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United States
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Contacts
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Contact type:
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Public
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Name:
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Stacy Meluskey
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Address:
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7575 Gateway Blvd. Suite 110
CA 94560
Newark
United States |
Telephone:
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+15102938141 |
Email:
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smeluskey@cymabay.com |
Affiliation:
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CymaBay Therapeutics, Inc. |
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Contact type:
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Scientific
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Name:
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Stacy Meluskey
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Address:
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7575 Gateway Blvd. Suite 110
CA 94560
Newark
United States |
Telephone:
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+15102938141 |
Email:
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smeluskey@cymabay.com |
Affiliation:
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CymaBay Therapeutics, Inc. |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Primary Biliary Cholangitis MedDRA version: 21.0
Level: LLT
Classification code 10036680
Term: Primary biliary cirrhosis
System Organ Class: 100000004871
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Therapeutic area: Body processes [G] - Immune system processes [G12]
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Intervention(s)
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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-
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Primary Outcome(s)
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Secondary Objective: To evaluate the long-term efficacy of seladelpar, and the effect of seladelpar on patient-reported outcomes (pruritus)
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Main Objective: To evaluate the long-term safety and tolerability of seladelpar
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Timepoint(s) of evaluation of this end point: Throughout the study
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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
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Secondary Outcome(s)
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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
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Timepoint(s) of evaluation of this end point: Throughout the study
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Secondary ID(s)
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CB8025-31731-RE
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2020-005198-29-DE
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NCT03301506
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Source(s) of Monetary Support
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CymaBay Therapeutics, Inc.
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Ethics review
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Status: |
Approved
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Approval date: |
20/04/2021
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Results
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Results available: |
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URL: |
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URL of the protocol: |
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Date Posted: |
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Date of completion: |
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Date of first publication: |
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Results summary: |
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Baseline characteristics: |
No results available |
Adverse events: |
No results available |
Outcome measures: |
No results available |
IPD sharing plan: |
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IPD sharing description: |
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