Back to resultsA Study of CM310 in Subjects With Chronic Pruritus
Primary Purpose
Chronic Pruritus of Unknown Origin
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CM310
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pruritus of Unknown Origin
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old.
- With chronic pruritus of unknown origin.
- With the worst pruritus numerical rating scale (WI-NRS) ≥7.
- Contraception.
Exclusion Criteria:
- Heavy drinking in the 3 months prior to screening.
- With severe hepatic and renal impairment.
- Previous history of autosensitivity dermatitis.
- Allergic to CM310/placebo.
- Vaccination with live attenuated vaccine within 12 weeks before randomization or during the planned study period.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CM310
Placebo
Arm Description
600 mg (first dosing) + 300 mg (subsequent dosing), once every two weeks
once every two weeks
Outcomes
Primary Outcome Measures
Percentage change of weekly average in the worst itching numerical rating scale (WI-NRS)
Change from baseline in the worst itching numerical rating scale at week 16
Secondary Outcome Measures
Safety parameters
Incidence of treatment-emergent adverse events (TEAEs).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05452343
Brief Title
A Study of CM310 in Subjects With Chronic Pruritus
Official Title
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Chronic Pruritus of Unknown Origin
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 30, 2022 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keymed Biosciences Co.Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM310 in subjects with chronic pruritus of unknown origin.
Detailed Description
The study consists of a Screening Period (up to 4 weeks), Treatment Period (16 weeks) and Safety Follow-up Period (8 weeks).
50 subjects who meet eligibility criteria will be randomized 1:1 to receive either CM310 300 mg or matched placebo subcutaneously every two weeks (Q2W) for a total of 8 times. All subjects will receive mometasone furoate nasal spray (MFNS) on a daily basis as a background treatment throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pruritus of Unknown Origin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CM310
Arm Type
Experimental
Arm Description
600 mg (first dosing) + 300 mg (subsequent dosing), once every two weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
once every two weeks
Intervention Type
Biological
Intervention Name(s)
CM310
Intervention Description
600 mg (first doing) + 300 mg (subsequent dosing), once every two weeks
Primary Outcome Measure Information:
Title
Percentage change of weekly average in the worst itching numerical rating scale (WI-NRS)
Description
Change from baseline in the worst itching numerical rating scale at week 16
Time Frame
at week 16
Secondary Outcome Measure Information:
Title
Safety parameters
Description
Incidence of treatment-emergent adverse events (TEAEs).
Time Frame
Baseline up to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old.
With chronic pruritus of unknown origin.
With the worst pruritus numerical rating scale (WI-NRS) ≥7.
Contraception.
Exclusion Criteria:
Heavy drinking in the 3 months prior to screening.
With severe hepatic and renal impairment.
Previous history of autosensitivity dermatitis.
Allergic to CM310/placebo.
Vaccination with live attenuated vaccine within 12 weeks before randomization or during the planned study period.
12. IPD Sharing Statement
Learn more about this trial
A Study of CM310 in Subjects With Chronic Pruritus
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