Chronic Pruritus of Unknown OriginPhase 2NCT05452343
A Study of CM310 in Subjects With Chronic Pruritus
A Phase 2 study testing CM310 in people with Chronic Pruritus of Unknown Origin, run by Keymed Biosciences Co.Ltd.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pruritus of Unknown Origin
- What is being tested?
- CM310
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2022to 1 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- With chronic pruritus of unknown origin.
- With the worst pruritus numerical rating scale (WI-NRS) ≥7.
- Contraception.
Who cannot join
- 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.
About this study
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
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.
- Conditions
- Chronic Pruritus of Unknown Origin
- Being tested
- CM310
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM310Biological
600 mg (first doing) + 300 mg (subsequent dosing), once every two weeks
| Study group | Role | What they receive |
|---|---|---|
| CM310 | Experimental | 600 mg (first dosing) + 300 mg (subsequent dosing), once every two weeks Receives: Biological: CM310 |
| Placebo | Placebo comparator | once every two weeks Receives: Biological: CM310 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at week 16
Secondary outcomes (1)
Safety parameters
Incidence of treatment-emergent adverse events (TEAEs).
Measured: Baseline up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start30 Aug 2022 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pruritus of Unknown OriginStudies of the same condition, open and under way.
- More trials run by Keymed Biosciences Co.LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452343
- Sponsor's protocol ID
- CM310_IIS_CP02
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05452343
- Acronym / sponsor ID
- CM310_IIS_CP02
- Conditions
- Chronic Pruritus of Unknown Origin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2022 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM310 | Experimental | Biological: CM310600 mg (first dosing) + 300 mg (subsequent dosing), once every two weeks |
| Placebo | Placebo comparator | Biological: CM310once every two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old.
- With chronic pruritus of unknown origin.
- With the worst pruritus numerical rating scale (WI-NRS) ≥7.
- Contraception.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM310600 mg (first doing) + 300 mg (subsequent dosing), once every two weeks | Biological | CM310, Placebo |
Primary outcome
Percentage change of weekly average in the worst itching numerical rating scale (WI-NRS)
Time frame: at week 16
Change from baseline in the worst itching numerical rating scale at week 16
1 secondary outcome
Safety parameters
Time frame: Baseline up to Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CM310 in people with Chronic Pruritus of Unknown Origin, run by Keymed Biosciences Co.Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change of weekly average in the worst itching numerical rating scale (WI-NRS) (time frame: at week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.