Chronic Kidney Disease-associated PruritusPhase 2ITCHINESSNCT05482698
The MC2-25 Cream in Subjects wITh CHronic KIdNEy Disease-aSsociated prurituS (ITCHINESS) Trial
A Phase 2 study testing MC2-25 cream in people with Chronic Kidney Disease-associated Pruritus, run by MC2 Therapeutics at 1 site in United Kingdom.
Trial summary
The purpose of this study is to access the efficacy and safety of MC2-25 cream and MC2-25 vehicle for treatment of chronic kidney disease associated pruritus (CKD)-aP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease-associated Pruritus
- What is being tested?
- MC2-25 cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2022to 2 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult males or non-pregnant females of any race or ethnicity who are ≥ 18 years of age at the time of screening
- Has provided written informed consent
- Chronic (>3 months) kidney disease (CKD) stages G3-G5 (i.e., estimated glomerular filtration rate [eGFR] by CKD-EPI creatinine 2021 equation <60 mL/min/1.73 m2)
- Specifically for CKD subjects on haemodialysis (HD) or haemodiafiltration (HDF):
- Subjects must be established on HD or HDF 3 times per week continuously for at least 3 months prior to the start of screening and must not have plans to change from HD to HDF or vice versa during the trial
- Subjects who require an occasional additional HD or HDF treatment to manage fluid overload may be enrolled as long as it is anticipated that no more than 4 such treatments will be required in any given month
- At least moderate CKD-aP defined as WI-NRS ≥4
- Female subjects must be of either: a. Non-childbearing potential or b. Childbearing potential
Who cannot join
- Has a functioning kidney transplant or is scheduled to receive a kidney transplant during the trial (Note: subject can be on waiting list for kidney transplant)
- Subjects who receive peritoneal dialysis
- In the opinion of the investigator has pruritus attributed to a cause other than CKD or its complications
- Has localized itch restricted to the palms of the hands
- Has concurrent skin conditions (including but not limited to pruritic dermatoses, active skin infections, ulcerations) that may limit or prevent application of MC2-25 cream or MC2-25 vehicle or that may interfere with evaluation of the effects of MC2-25 cream or MC2-25 vehicle on the skin at the Screening or Baseline visits
- Subjects who will have skin biopsies performed must not have any known hypersensitivity to the local anaesthetic or diagnosed bleeding disorders
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- Has a concurrent or recent (within 12 months prior to screening) medical condition that, in the opinion of the investigator, could pose undue risk to the subject, impede completion of the trial procedures, or would compromise the validity of the trial measurements
- Has a known current generalized infection (bacterial, viral, or fungal)
- Start of a new or change to existing systemic treatment for CKD-aP
- Use of emollients on CKD-aP areas within 10 days prior to the Baseline visit
- Use of any topical treatment on CKD-aP areas
- Use of any light therapy for CKD-aP
- Use of non-biologic systemic immunosuppressive treatment
- Use of biologic systemic treatment
- Subjects not currently on dialysis but who are likely to initiate routine dialysis during participation in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Parallel-group (2-Arm), Randomized, Double-blind, 12-week Trial to Evaluate the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Subjects With Chronic Kidney Disease-associated Pruritus (CKD-aP)
The purpose of this study is to access the efficacy and safety of MC2-25 cream and MC2-25 vehicle for treatment of chronic kidney disease associated pruritus (CKD)-aP).
Read the detailed description
In this trial, subjects who fulfil all inclusion and exclusion criteria are enrolled.
Eligible subjects will be randomised in a 2:1 ratio to MC2-25 cream or MC2-25 vehicle, respectively.
The subjects will apply the assigned investigational medicinal product (IMP) twice daily for 12 weeks.
- Being tested
- MC2-25 cream, MC2-25 vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC2-25 creamDrug
Topical application
MC2-25 vehicleDrug
Topical application
| Study group | Role | What they receive |
|---|---|---|
| MC2-25 cream | Experimental | MC2-25 cream Twice daily applications for 12 weeks Receives: Drug: MC2-25 cream |
| MC2-25 vehicle | Placebo comparator | MC2-25 vehicle Twice daily applications for 12 weeks Receives: Drug: MC2-25 vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS)
Mean change in WI-NRS score, calculated as the average of weekly means WI-NRS values from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle. Weekly mean WI-NRS is calculated as the average of all and at least 4 non-missing WI-NRS values recorded in the subjects' diaries for the 7 days prior to and including the scheduled in clinic visits (8 days in total expected). The WI-NRS was scored on a 11-point numeric rating scale ranging from 0 to 10, where 0=no itch and 10=worst imaginable itch.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Jul 2022
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney Disease-associated PruritusStudies of the same condition, open and under way.
- 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
- Model description
- Parallel-group, Randomized, Double-blind
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- MC2 Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482698
- Sponsor's protocol ID
- MC2-25-C1
- Acronym
- ITCHINESS
- Status last verified
- Feb 2025
- First submitted
- 29 Jul 2022
- Last updated
- 17 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel-group (2-Arm), Randomized, Double-blind, 12-week Trial to Evaluate the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Subjects With Chronic Kidney Disease-associated Pruritus (CKD-aP)
- ClinicalTrials.gov ID
- NCT05482698
- Acronym / sponsor ID
- ITCHINESS / MC2-25-C1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- MC2 TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Posted 17 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to access the efficacy and safety of MC2-25 cream and MC2-25 vehicle for treatment of chronic kidney disease associated pruritus (CKD)-aP).
Detailed description
In this trial, subjects who fulfil all inclusion and exclusion criteria are enrolled.
Eligible subjects will be randomised in a 2:1 ratio to MC2-25 cream or MC2-25 vehicle, respectively.
The subjects will apply the assigned investigational medicinal product (IMP) twice daily for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group, Randomized, Double-blind
| Arm | Type | Receives |
|---|---|---|
| MC2-25 cream | Experimental | Drug: MC2-25 creamMC2-25 cream Twice daily applications for 12 weeks |
| MC2-25 vehicle | Placebo comparator | Drug: MC2-25 vehicleMC2-25 vehicle Twice daily applications for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult males or non-pregnant females of any race or ethnicity who are ≥ 18 years of age at the time of screening
- Has provided written informed consent
- Chronic (>3 months) kidney disease (CKD) stages G3-G5 (i.e., estimated glomerular filtration rate [eGFR] by CKD-EPI creatinine 2021 equation <60 mL/min/1.73 m2)
- Specifically for CKD subjects on haemodialysis (HD) or haemodiafiltration (HDF):
- At least moderate CKD-aP defined as WI-NRS ≥4
Key exclusion criteria (15 listed)
- Has a functioning kidney transplant or is scheduled to receive a kidney transplant during the trial (Note: subject can be on waiting list for kidney transplant)
- Subjects who receive peritoneal dialysis
- In the opinion of the investigator has pruritus attributed to a cause other than CKD or its complications
- Has localized itch restricted to the palms of the hands
- Has concurrent skin conditions (including but not limited to pruritic dermatoses, active skin infections, ulcerations) that may limit or prevent application of MC2-25 cream or MC2-25 vehicle or that may interfere with evaluation of the effects of MC2-25 cream or MC2-25 vehicle on the skin at the Screening or Baseline visits
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 |
|---|---|---|
| MC2-25 creamTopical application | Drug | MC2-25 cream |
| MC2-25 vehicleTopical application | Drug | MC2-25 vehicle |
Primary outcome
Mean Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS)
Time frame: 12 weeks
Mean change in WI-NRS score, calculated as the average of weekly means WI-NRS values from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle. Weekly mean WI-NRS is calculated as the average of all and at least 4 non-missing WI-NRS values recorded in the subjects' diaries for the 7 days prior to and including the scheduled in clinic visits (8 days in total expected). The WI-NRS was scored on a 11-point numeric rating scale ranging from 0 to 10, where 0=no itch and 10=worst imaginable itch.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MC2-25 cream in people with Chronic Kidney Disease-associated Pruritus, run by MC2 Therapeutics at 1 site in United Kingdom.
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 8 inclusion and 15 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: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS) (time frame: 12 weeks). 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 17 Mar 2025.