What side effects are associated with this type of intervention?

Common treatments for Prurigo Nodularis include topical corticosteroids, phototherapy, and systemic immunosuppressants. For JAK inhibitors like INCB054707, which are being studied for their efficacy in treating this condition, known side effects can include increased risk of infections, headaches, gastrointestinal issues, and elevated liver enzymes. It is important for patients to discuss these potential side effects with their healthcare provider to weigh the benefits and risks of treatment.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments exclusively for Prurigo Nodularis. However, Janus kinase (JAK) inhibitors, like INCB054707, are being studied for their potential efficacy in treating this condition. JAK inhibitors, such as ruxolitinib and tofacitinib, have been approved for other dermatological conditions like atopic dermatitis and psoriasis, showing promise in modulating immune responses and reducing inflammation. These approvals suggest a potential pathway for similar treatments to be considered for Prurigo Nodularis in the future.

What other types of research exist?

Promising novel alternatives to INCB054707 for Prurigo Nodularis patients in 2024 include: 1. Dupilumab, an IL-4 receptor alpha antagonist, which has shown efficacy in treating chronic pruritic conditions. 2. Nemolizumab, an IL-31 receptor antagonist, which is being investigated for its antipruritic effects. 3. Ruxolitinib cream, another JAK inhibitor, which has shown promise in treating atopic dermatitis and may be effective for PN. These alternatives are based on their mechanisms of action and clinical trial results in related pruritic conditions.

← Back to Search

Unknown

INCB054707 for Prurigo Nodularis

Phase 2

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 20 pruriginous lesions on ≥ 2 different body regions at screening and Day 1

Be older than 18 years old

Must not have

Women who are pregnant (or who are considering pregnancy) or lactating

Current use of a medication known to cause pruritus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 48

Summary

This trial will study whether a new medication is effective and safe for treating prurigo nodularis, a skin condition.

Who is the study for?

This trial is for people with a skin condition called prurigo nodularis, who have at least 20 itchy bumps on two or more body areas and haven't found relief with other treatments. They should not be pregnant or planning to become so, and must have had the diagnosis for over three months.

What is being tested?

The study tests INCB054707 against a placebo over 16 weeks to see if it's effective and safe in treating prurigo nodularis. After this phase, there's an additional 24-week period where all participants receive the actual drug without knowing if they initially received the drug or placebo.

What are the potential side effects?

While specific side effects are not listed here, common ones may include reactions at the medication application site, general discomforts like headaches or nausea, potential infection risks due to immune system changes, and possibly others as determined during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have more than 20 itchy spots on at least 2 different parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant, considering pregnancy, or breastfeeding.

Select...

I am currently taking medication that causes itching.

Select...

I have an active, latent, or untreated TB infection.

Select...

I am known to have HIV, Hepatitis B, or Hepatitis C.

Select...

I have a condition causing chronic itching without a known skin disease.

Select...

I have long-term itching not caused by nerve damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16

Secondary study objectives

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Proportion of participants achieving Investigator's Global Assessment Treatment Success (IGA-TS)

Time to ≥ 4-point improvement from baseline in Itch NRS score

Side effects data

From 2019 Phase 2 trial • 10 Patients • NCT03569371

30%

Upper respiratory tract infection

10%

Nausea

10%

Headache

10%

Fibromyalgia

10%

Anxiety

10%

Rash

10%

Night sweats

100%

80%

60%

40%

20%

Study treatment Arm

INCB054707

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: INCB054707 Dose CExperimental Treatment1 Intervention

Participants will receive INCB054707 Dose C for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).

Group II: INCB054707 Dose BExperimental Treatment1 Intervention

Participants will receive INCB054707 Dose B for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).

Group III: INCB054707 Dose AExperimental Treatment1 Intervention

Participants will receive INCB054707 Dose A for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).

Group IV: Placebo followed by INCB054707 Dose B or CPlacebo Group1 Intervention

Participants will receive placebo for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INCB054707

2018

Completed Phase 2

~670

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Janus kinase (JAK) inhibitors, such as INCB054707, work by blocking the activity of enzymes in the JAK family, which play a crucial role in the signaling pathways that lead to inflammation. By inhibiting these pathways, JAK inhibitors can reduce the inflammatory response, thereby alleviating symptoms like severe itching and nodular skin lesions. This mechanism is particularly beneficial for Prurigo Nodularis patients, as it addresses the chronic inflammation and intense itching that characterize the condition, potentially improving their quality of life.

Efficacy of topical treatments for molluscum contagiosum in randomized controlled trials.Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial.