Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP)
Conditions
Brief summary
This is a Phase 2, randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of CLE-400 topical gel for the treatment of chronic pruritus in adult subjects with Notalgia Paresthetica (NP).
Detailed description
Study to assess the efficacy and safety of CLE-400 topical gel applied once daily for the treatment of moderate-severe chronic pruritus in adult subjects with NP. The study comprises a screening phase of up to 37 days, including a 7-day run-in period, a 4-week double-blind treatment period, and a 2-week follow-up period.
Interventions
DRUGCLE-400
Topical CLE400 gel 0.28% administered once daily
DRUGVehicle
Topical vehicle gel administered once daily
Sponsors
Clexio Biosciences Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double
Intervention model description
54 subjects, 2 arms, parallel
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject has a confirmed diagnosis of Notalgia Paresthetica. * Subject has a history of chronic pruritus (itch) due to Notalgia Paresthetica. * Subject has moderate to severe pruritus. * Subject is able and competent to read and sign the informed consent form (ICF).
Exclusion criteria
* Subject has chronic pruritus that is related to a condition other than Notalgia Paresthetica. * Subject with known or suspected history of a clinically significant systemic disease, unstable medical disorders, life-threatening disease, including physical/laboratory/ECG/vital signs abnormality that would put the subject at undue risk or interfere with interpretation of study results * Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) Score at Week 4. | Baseline, Week 4 (28 days). | The WI-NRS is a tool used to assess the intensity of the most severe (worst) pruritus (itch), as experienced by the subject, in the last 24 hours. WI-NRS scale score ranges from 0 to 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CLE-400 (Detomidine Topical Gel) Topical CLE-400 gel 0.28% once daily
CLE-400: Topical CLE400 gel 0.28% administered once daily | 28 |
| Vehicle Topical vehicle gel once daily
Vehicle: Topical vehicle gel administered once daily | 31 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | CLE-400 (Detomidine Topical Gel) | Vehicle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 11 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 20 Participants | 38 Participants |
| Age, Continuous | 61.82 years STANDARD_DEVIATION 8.2 | 60.48 years STANDARD_DEVIATION 10.5 | 61.12 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 11 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 20 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 29 Participants | 56 Participants |
| Region of Enrollment United States | 28 participants | 31 participants | 59 participants |
| Sex: Female, Male Female | 21 Participants | 24 Participants | 45 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 31 |
| other Total, other adverse events | 8 / 28 | 5 / 31 |
| serious Total, serious adverse events | 0 / 28 | 0 / 31 |
Outcome results
Primary
Percent Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) Score at Week 4.
The WI-NRS is a tool used to assess the intensity of the most severe (worst) pruritus (itch), as experienced by the subject, in the last 24 hours. WI-NRS scale score ranges from 0 to 10, with 0 indicating no itch and 10 indicating the worst itch imaginable.
Time frame: Baseline, Week 4 (28 days).
Population: The FAS is a subset of the ITT analysis set and will include all randomized subjects who received at least 1 dose of study treatment and have both baseline and at least one post-baseline weekly mean WI-NRS evaluation. In this analysis set, treatment is assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received. The FAS serves as the principal analysis set for efficacy inference.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CLE-400 (Detomidine Topical Gel) | Percent Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) Score at Week 4. | -44.37 percentage of change from baseline | Standard Error 5.75 |
| Vehicle | Percent Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) Score at Week 4. | -50.37 percentage of change from baseline | Standard Error 5.43 |
p-value: 0.442295% CI: [-9.54, 21.53]Mixed Models Repeated Measures (MMRM)