RecruitingPhase 2

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

United States, China135 participantsStarted 2025-11-27

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Voluntarily sign informed consent forms before any investigational procedure(s) are performed.
✓. Male or female aged between 18 and 75 years at the time of signing the informed consent.
✓. Clinical diagnosis of PN by a dermatologist for at least 3 months before the Screening visit.
✓. 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.
✓. PP NRS score ≥ 7 at both screening and the baseline (Day 1) visits.
✓. IGA-CPG-S score ≥ 3 at both the screening and the baseline (Day 1) visits.
✓. 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).

✕. 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 .
✕. 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.

Peak pruritus-numeric rate scale (PP NRS)

Timeframe: Baseline to week 16

NCT IDNCT07236099

SponsorBeijing InnoCare Pharma Tech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Alexia Lu

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Voluntarily sign informed consent forms before any investigational procedure(s) are performed.
✓. Male or female aged between 18 and 75 years at the time of signing the informed consent.
✓. Clinical diagnosis of PN by a dermatologist for at least 3 months before the Screening visit.
✓. 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.
✓. PP NRS score ≥ 7 at both screening and the baseline (Day 1) visits.
✓. IGA-CPG-S score ≥ 3 at both the screening and the baseline (Day 1) visits.
✓. 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).

✕. 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 .
✕. 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.