NCT05452343

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 30, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

1.5 years

First QC Date

July 6, 2022

Last Update Submit

July 6, 2022

Conditions

Chronic Pruritus of Unknown Origin

Outcome Measures

Primary Outcomes (1)

  • 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

    at week 16

Secondary Outcomes (1)

  • Safety parameters

    Baseline up to Week 24

Study Arms (2)

CM310

EXPERIMENTAL

600 mg (first dosing) + 300 mg (subsequent dosing), once every two weeks

Biological: CM310

Placebo

PLACEBO COMPARATOR

once every two weeks

Biological: CM310

Interventions

CM310BIOLOGICAL

600 mg (first doing) + 300 mg (subsequent dosing), once every two weeks

CM310Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old.
  • With chronic pruritus of unknown origin.
  • With the worst pruritus numerical rating scale (WI-NRS) ≥7.
  • Contraception.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 11, 2022

Study Start

August 30, 2022

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

July 11, 2022

Record last verified: 2022-07