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Status unknownNCT05452343Updated Jul 11, 2022

A Study of CM310 in Subjects With Chronic Pruritus

A Phase 2 interventional study of CM310 in Chronic Pruritus of Unknown Origin, sponsored by Keymed Biosciences Co.Ltd. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-11.

Sponsored by Keymed Biosciences Co.Ltd · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Pruritus of Unknown Origin
03

In context

Lead sponsor

Keymed Biosciences Co.Ltd is the lead sponsor of 66 studies on the registry; 32 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    CM310

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

    Biological: CM310

  • Placebo comparator
    Placebo

    once every two weeks

    Biological: CM310

Interventions

  • BiologicalCM310

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

06

What researchers measure

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

    Time frame: at week 16

Secondary outcomes

  1. Safety parameters

    Incidence of treatment-emergent adverse events (TEAEs).

    Time frame: Baseline up to Week 24

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2022; primary completion for Mar 2024, 18 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2022
First posted
Jul 11, 2022
StartEst.
Aug 30, 2022
Primary completionEst.
Mar 1, 2024
CompletionEst.
Mar 1, 2024
Last update
Jul 11, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05452343
Lead sponsor
Keymed Biosciences Co.Ltd
Responsible party
Sponsor
First posted
Jul 11, 2022
Start date
Aug 30, 2022 (estimated)
Primary completion
Mar 1, 2024 (estimated)
Completion
Mar 1, 2024 (estimated)
Last update
Jul 11, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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