Prurigo Nodularis (PN)
Conditions
Brief summary
Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)
Interventions
DRUGICP-322
ICP-322 Tablets
DRUGPlacebo
ICP-332 Placebo Tablets
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak pruritus-numeric rate scale (PP NRS) | Baseline to week 16 | Percent change from baseline of weekly average in Peak pruritus-numeric rate scale (PP NRS) at Week 16. Participants will be asked to rate their itch at the worst moment during the previous 24 hours. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in PP NRS score | Baseline through week 40 | Proportion of participants achieving ≥ 4-point improvement in PP NRS score (PP NRS ≥ 4) over time |
| Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1) | Baseline through week 40 | Proportion of participants achieving Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1) over time |
| Dermatology Life Quality Index (DLQI) | Baseline through week 40 | Change from baseline in Dermatology Life Quality Index (DLQI) score over time. The DLQI comprises 10 items assessing the impact of skin disease on patients' health-related quality of life (HRQoL) over the previous week. Overall scoring ranges from 0 to 30, with a high score indicative of a poor HRQoL |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Baseline through week 40 | — |
| Maximum concentration (Cmax) | Baseline through week 40 | Maximum concentration (Cmax) of ICP-322 |
| Area Under Concentration Versus Time Curve (AUC) | Baseline through week 40 | Area Under Concentration Versus Time Curve (AUC) of ICP-322 |
Countries
China, France, Germany, Poland, United States
Contacts
CONTACTAlexia Lu
Outcome results
None listed