CM-101 in PSC Patients -The SPRING Study
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04595825 |
Recruitment Status :
Active, not recruiting
First Posted : October 22, 2020
Last Update Posted : January 9, 2024
|
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | October 7, 2020 | ||||
First Posted Date ICMJE | October 22, 2020 | ||||
Last Update Posted Date | January 9, 2024 | ||||
Actual Study Start Date ICMJE | October 1, 2020 | ||||
Estimated Primary Completion Date | September 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Safety-related endpoints - number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: 15 week double-blind (DB) treatment period ] Frequency and severity of treatment-emergent adverse events (TEAEs), including vital sign changes, changes in clinical safety laboratories and evaluation of infusion site reactions.
|
||||
Original Primary Outcome Measures ICMJE |
|
||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | CM-101 in PSC Patients -The SPRING Study | ||||
Official Title ICMJE | 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) | ||||
Brief Summary | This study is designed to assess the safety, tolerability and activity of the anti-human CCL24 monoclonal antibody CM-101 in adult subjects with Primary Sclerosing Cholangitis (PSC). At least 68 subjects at approximately 50 sites will be randomized to receive either CM-101 at doses of 10 mg/kg or 20 mg/kg or matching placebo. | ||||
Detailed Description | This study will consist of a screening period, double-blind (DB) treatment period, open-label (OL) treatment period, and safety follow-up period. During the DB treatment period, subjects will receive 5 total dose administrations of study drug (investigational product - IP or placebo) once every 3 weeks (Q3W) for a coverage of 15 weeks. After completing the DB treatment period, subjects may elect to enroll in an OL treatment period. In the OL treatment period, subjects will receive a dose of IP Q3W for 11 administrations for a coverage of 33 weeks, resulting in a combined total coverage of up to 48 weeks. Subjects who do not elect to continue treatment in the OL dosing period will undergo an End of Treatment (EOT)-DB visit at Week 15 (Day 105), a Safety Follow-up Call at Week 21 (Day 147), and an End of Study (EOS) visit at Week 27. Eligible subjects who continue treatment in the OL treatment period will receive CM-101 at either a 10 mg/kg or 20 mg/kg dose commencing at Week 15 (OL Treatment 1), and the subjects will undergo an EOT-OL visit at Week 48 (Day 336), a Safety Follow-up Call at Week 54 (Day 378), and an EOS visit at Week 60 (Day 420). |
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
||||
Condition ICMJE | Primary Sclerosing Cholangitis | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
68 | ||||
Original Estimated Enrollment ICMJE |
45 | ||||
Estimated Study Completion Date ICMJE | September 2025 | ||||
Estimated Primary Completion Date | September 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Subjects with ulcerative colitis: Must be either in remission or have mild disease. Must have recent colonoscopy with biopsy confirming no dysplasia or colorectal cancer or history of colectomy.
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Germany, Israel, Spain, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04595825 | ||||
Other Study ID Numbers ICMJE | CM-101-PSC-101 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | ChemomAb Ltd. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | ChemomAb Ltd. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | ChemomAb Ltd. | ||||
Verification Date | January 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |