135 Participants NeededMy employer runs this trial

ICP-332 for Prurigo Nodularis

Recruiting at 15 trial locations
AL
Overseen ByAlexia Lu
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ICP-332, a potential drug, to evaluate its effectiveness and safety for people with Prurigo Nodularis (PN), a skin condition that causes itchy bumps. Participants will receive one of two doses of ICP-332 or a placebo (a pill with no active medicine) to compare results. It suits those diagnosed with PN by a dermatologist for at least three months, who have at least 20 itchy lesions, and who haven't found success with certain topical treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to potential advancements in PN treatment.

Is there any evidence suggesting that ICP-332 is likely to be safe for humans?

Research has shown that ICP-332 is generally safe. In a recent study, most participants tolerated the treatment well. Some experienced mild to moderate side effects, such as headaches or mild skin reactions. These side effects occurred in 76% of those taking the 80 mg dose and 75% of those on a higher dose. Importantly, these side effects resembled those in participants taking a placebo, a harmless pill with no active drug. This suggests ICP-332 is generally safe for humans.12345

Why are researchers excited about this trial's treatments?

Unlike existing treatments for prurigo nodularis, which often include corticosteroids and immunosuppressants, ICP-332 works by targeting a specific pathway involved in the itch and inflammation process. This novel mechanism could potentially offer relief with fewer side effects compared to the current standards of care. Researchers are particularly excited about ICP-332 because it comes in two dosage forms—80mg and 120mg—allowing for flexibility in treatment tailored to patient needs. This approach might provide a more precise and effective solution for managing prurigo nodularis.

What evidence suggests that ICP-332 might be an effective treatment for Prurigo Nodularis?

Research has shown that ICP-332, a new treatment under study in this trial, may help with skin conditions like prurigo nodularis. Studies have found that it can quickly reduce the frequency and severity of itching. Individuals with similar skin issues reported improved skin condition scores after using ICP-332. This treatment targets specific parts of the immune system responsible for inflammation and itching. Early evidence suggests that ICP-332 could effectively manage symptoms of prurigo nodularis.12367

Are You a Good Fit for This Trial?

Inclusion Criteria

My IGA-CPG-S score is 3 or higher on two different visits.
I am between 18 and 75 years old.
I have been diagnosed with PN by a skin doctor for at least 3 months.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ICP-332 or placebo for the treatment of Prurigo Nodularis

16 weeks
Regular visits for assessment and medication administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks
Periodic visits for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

  • ICP-332

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: ICP-332 80mgExperimental Treatment1 Intervention
Group II: ICP-332 120mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beijing InnoCare Pharma Tech Co., Ltd.

Lead Sponsor

Trials
48
Recruited
6,000+

Citations

NCT07236099 | Study of the Efficacy and Safety of ICP-332 ...

No Results Posted Record History. Study Overview. Brief Summary. Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN).

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41533373/

Safety and Efficacy of ICP-332 for Moderate to Severe ...

Main outcomes and measures: The primary outcome was safety. The key efficacy outcome was the percentage change from baseline in Eczema Area ...

688428), a leading biopharmaceutical company focusing ...

The global prurigo nodularis market was valued at US$2 billion in 2024 and is expected to grow to US$3 billion in 2034. Dr. Jasmine Cui, Co- ...

Study Results of Novel TYK2 Inhibitor Soficitinib in Patients ...

Substantial reductions in Pruritus NRS severity and frequency scores were observed on day 2 of treatment compared to placebo, with continued ...

ICYMI: First Patient Dosed in Global Phase 2 Study of Oral ...

The phase 2 clinical study of soficitinib for moderate-to-severe atopic dermatitis demonstrated outstanding efficacy and a strong safety profile ...

Study of the Efficacy and Safety of ICP-332 in Participants ...

Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN). Criteria: Inclusion Criteria :~1. Voluntarily sign informed consent ...

Study of the Efficacy and Safety of ICP-332 in Participants ...

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