Clinical trial NCT06262607: A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects with Notalgia Paresthetica
Official title: A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-Design, Phase 2 Study to Assess the Efficacy and Safety of CLE-400 Topical Gel for the Treatment of Chronic Pruritus in Adult Subjects with Notalgia Paresthetica
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pruritus in Adult Subjects with Notalgia Paresthetica (NP)
Lead sponsor: Clexio Biosciences Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-16
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 54 subjects, 2 arms, parallel
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent change from baseline in weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 4.
timeFrame: Baseline, Week 4.
Secondary outcomes:
Other outcomes:
Locations:
city: Bryant
country: United States
facility: Clinical site 11
state: Arkansas
city: Fremont
country: United States
facility: Clinical Site 21
state: California
city: Coral Gables
country: United States
facility: Clinical site 01
state: Florida
city: Margate
country: United States
facility: Clinical Site 13
state: Florida
city: North Miami Beach
country: United States
facility: Clinical Site 10
state: Florida
city: Indianapolis
country: United States
facility: Clinical Site 02
state: Indiana
city: Methuen
country: United States
facility: Clinical Site 23
state: Massachusetts
city: Portsmouth
country: United States
facility: Clinical Site 20
state: New Hampshire
city: New York
country: United States
facility: Clinical Site 15
state: New York
city: High Point
country: United States
facility: Clinical site 03
state: North Carolina
city: Dublin
country: United States
facility: Clinical Site 09
state: Ohio
city: Houston
country: United States
facility: Clinical site 16
state: Texas
city: San Antonio
country: United States
facility: Clinical Site 06
state: Texas
Study officials:
References: