Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis

InnoCare Pharma

Status and phase: Enrolling; Phase 2

Conditions: Prurigo Nodularis (PN)

Treatments: Drug: Placebo; Drug: ICP-322

Study type: Interventional

Funder types: Industry

Identifiers

NCT07236099

ICP-CL-00609

Details and patient eligibility

About

Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)

Enrollment: 135 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

1. Voluntarily sign informed consent forms before any investigational procedure(s) are performed.
2. Male or female aged between 18 and 75 years at the time of signing the informed consent.
3. Clinical diagnosis of PN by a dermatologist for at least 3 months before the Screening visit.
4. At least 20 pruriginous lesions on the entire body with a bilateral distribution (on both legs, and/or both arms and/or trunk) at both screening and the baseline (Day 1) visits.
5. PP NRS score ≥ 7 at both screening and the baseline (Day 1) visits.
6. IGA-CPG-S score ≥ 3 at both the screening and the baseline (Day 1) visits.
7. History of inadequate response to topical corticosteroid of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).

Willingness to avoid pregnancy or fathering children

Exclusion Criteria:

1. Patients with a documented AD severity moderate to severe presence of skin morbidities other than PN and mild AD that may interfere with the assessment of the study outcomes. PN secondary to medications .
2. Any uncontrolled or serious disease, or any medical, psychological, or surgical condition including relevant laboratory abnormalities at screening that may either interfere with the interpretation of the clinical trial results and/or, in the investigator's judgment, would adversely affect the patient's participation in the study. Active chronic or acute infection participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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135 participants in 3 patient groups, including a placebo group

ICP-332 80mg

Experimental group

Treatment:

Drug: ICP-322

ICP-332 120mg

Experimental group

Treatment:

Drug: ICP-322

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo