Trial Outcomes & Findings for The MC2-25 Cream in Subjects wITh CHronic KIdNEy Disease-aSsociated prurituS (ITCHINESS) Trial (NCT NCT05482698)

Last Updated: 2025-03-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

111 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	MC2-25 Cream MC2-25 cream Twice daily applications for 12 weeks MC2-25 cream: Topical application	MC2-25 Vehicle MC2-25 vehicle Twice daily applications for 12 weeks MC2-25 vehicle: Topical application
Overall Study STARTED	73	38
Overall Study COMPLETED	65	33
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The MC2-25 Cream in Subjects wITh CHronic KIdNEy Disease-aSsociated prurituS (ITCHINESS) Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MC2-25 Cream n=73 Participants MC2-25 cream Twice daily applications for 12 weeks MC2-25 cream: Topical application	MC2-25 Vehicle n=38 Participants MC2-25 vehicle Twice daily applications for 12 weeks MC2-25 vehicle: Topical application	Total n=111 Participants Total of all reporting groups
Age, Continuous	62.0 Years STANDARD_DEVIATION 15.13 • n=5 Participants	66.9 Years STANDARD_DEVIATION 13.78 • n=7 Participants	63.7 Years STANDARD_DEVIATION 14.81 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	16 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	22 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants	38 Participants n=7 Participants	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants	31 Participants n=7 Participants	86 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United Kingdom	41 participants n=5 Participants	22 participants n=7 Participants	63 participants n=5 Participants
Region of Enrollment Germany	10 participants n=5 Participants	6 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment Hungary	22 participants n=5 Participants	9 participants n=7 Participants	31 participants n=5 Participants
Region of Enrollment Poland	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The number (59/34) of participants in the full analysis set is the number of subjects with at least a baseline weekly mean WI-NRS score

Outcome measures

Outcome measures
Measure	MC2-25 Cream n=59 Participants MC2-25 cream Twice daily applications for 12 weeks MC2-25 cream: Topical application	MC2-25 Vehicle n=34 Participants MC2-25 vehicle Twice daily applications for 12 weeks MC2-25 vehicle: Topical application
Mean Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS)	-3.70 score on a scale Standard Deviation 2.961	-3.87 score on a scale Standard Deviation 2.203

Adverse Events

MC2-25 Cream

Serious events: 11 serious events

Other events: 4 other events

Deaths: 1 deaths

MC2-25 Vehicle

Serious events: 6 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	MC2-25 Cream n=73 participants at risk MC2-25 cream Twice daily applications for 12 weeks MC2-25 cream: Topical application	MC2-25 Vehicle n=37 participants at risk MC2-25 vehicle Twice daily applications for 12 weeks MC2-25 vehicle: Topical application
General disorders Application site pain	5.5% 4/73 • Number of events 5 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Infections and infestations Upper respiratory tract infection	0.00% 0/73 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	5.4% 2/37 • Number of events 3 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.

Additional Information

Chief Medical Officer

MC2 Therapeutics

Phone: +45 2018 1111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	MC2-25 Cream n=73 participants at risk MC2-25 cream Twice daily applications for 12 weeks MC2-25 cream: Topical application	MC2-25 Vehicle n=37 participants at risk MC2-25 vehicle Twice daily applications for 12 weeks MC2-25 vehicle: Topical application
Gastrointestinal disorders Duodenal perforation	0.00% 0/73 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	2.7% 1/37 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Infections and infestations Cellulitis	0.00% 0/73 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	2.7% 1/37 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Renal and urinary disorders End stage renal disease	0.00% 0/73 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	2.7% 1/37 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Surgical and medical procedures Tooth extraction	1.4% 1/73 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Cardiac disorders Palpitations	1.4% 1/73 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	2.7% 2/73 • Number of events 2 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Nervous system disorders Ischaemic stroke	0.00% 0/73 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	2.7% 1/37 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Infections and infestations Bacteraemia	1.4% 1/73 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Cardiac disorders Pericarditis	1.4% 1/73 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Gastrointestinal disorders Diarrhoea	1.4% 1/73 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Infections and infestations Sepsis	1.4% 1/73 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Cardiac disorders Atrial fibrillation	1.4% 1/73 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Cardiac disorders Bradycardia	1.4% 1/73 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Musculoskeletal and connective tissue disorders Hematomas in the area of the left elbow joint and the laft knee joint	1.4% 1/73 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Infections and infestations Pneumonia	1.4% 1/73 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Renal and urinary disorders Chronic kidney disease	1.4% 1/73 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Infections and infestations Urosepsis	1.4% 1/73 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Cardiac disorders Angina Pectoris	1.4% 1/73 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Surgical and medical procedures Nephrectomy	0.00% 0/73 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	2.7% 1/37 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Infections and infestations Postoperative wound infection	0.00% 0/73 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	2.7% 1/37 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Nervous system disorders Hepatic encephalopathy	0.00% 0/73 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	2.7% 1/37 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Cardiac disorders Cardiac failure	1.4% 1/73 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.
Vascular disorders Hypertensive crisis	1.4% 1/73 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.	0.00% 0/37 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and through study completion, i.e. for a maximum of 18 weeks.