What is the mechanism of action of this treatment?

Prurigo Nodularis (PN) is often treated with Janus kinase (JAK) inhibitors like Ruxolitinib cream, which work by blocking the JAK-STAT signaling pathway involved in the inflammatory response. This inhibition reduces the production of pro-inflammatory cytokines, thereby decreasing inflammation and pruritus (itchiness) associated with PN. This mechanism is crucial for PN patients as it directly targets the underlying inflammatory processes that cause the characteristic nodules and intense itching, providing relief and improving quality of life. Other common treatments for PN may include corticosteroids and immunomodulators, which also aim to reduce inflammation and immune response.

What side effects are associated with this type of intervention?

Common treatments for Prurigo Nodularis include topical corticosteroids, tacrolimus, and Janus kinase inhibitors like Ruxolitinib cream. Topical corticosteroids can cause side effects such as burning sensation, dryness, erythema, and pruritus. Tacrolimus ointment is generally well-tolerated but may cause local irritation and a burning sensation. Ruxolitinib cream, being a Janus kinase inhibitor, is under study for its safety and tolerability, but potential side effects may include application site reactions and other mild to moderate skin irritations.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments exclusively for Prurigo Nodularis. However, treatments similar to Ruxolitinib cream, such as other Janus kinase (JAK) inhibitors, have been explored for various dermatological conditions. For instance, topical and systemic JAK inhibitors like Tofacitinib and Baricitinib have shown promise in treating conditions like atopic dermatitis, which shares some inflammatory pathways with Prurigo Nodularis. These treatments aim to reduce inflammation and pruritus by inhibiting the JAK-STAT signaling pathway.

What other types of research exist?

Promising, novel alternatives to Ruxolitinib cream for Prurigo Nodularis patients include topical tacrolimus ointment, which has been studied for resistant idiopathic pruritus ani, and methylene blue injection, which has shown long-term results for intractable idiopathic pruritus ani. These treatments may offer new avenues for managing PN.

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Janus Kinase (JAK) Inhibitor

Ruxolitinib Cream for Prurigo Nodularis (TRuE-PN2 Trial)

Phase 3

Recruiting

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

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

Must have

Willingness to avoid pregnancy or fathering children

Clinical diagnosis of PN ≥ 3 months before screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 56 weeks

Awards & highlights

Pivotal Trial

Summary

This trial tests the safety and tolerability of a cream for people with Prurigo Nodularis, a condition with itchy skin nodules. The cream works by blocking enzymes that cause inflammation and itching. It has been previously tested for its effects in conditions like atopic dermatitis.

Who is the study for?

This trial is for individuals with Prurigo Nodularis who've had it for at least 3 months, have a significant itch score (≥7), and more than six itchy lesions across two body areas. Participants must not be pregnant or planning to become so and should not have used certain medications recently.

What is being tested?

The study tests Ruxolitinib cream's effectiveness in reducing itching and improving skin condition compared to a placebo cream (Vehicle Cream). It aims to determine how safe and tolerable the medication is for people with Prurigo Nodularis.

What are the potential side effects?

While specific side effects are not listed, Ruxolitinib may commonly cause application site reactions, headaches, dizziness, or increased risk of infections. The trial will monitor participants closely for any adverse effects.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with peripheral neuropathy for at least 3 months.

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I have more than 6 itchy spots on at least 2 different parts of my body, covering less than 20% of my skin.

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You have a score of 2 or higher on the IGA-CPG-S test during screening and at the start of the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 56 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 56 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 56 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Worst-Itch Numeric Rating Scale (WI-NRS) ≥ 4-point improvement in WI-NRS score Response

Secondary study objectives

> 75% healed lesions from baseline in PAS at each postbaseline visit.

Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.

Change from baseline in EQ-5D-5L score at each postbaseline visit.

+12 more

Side effects data

From 2020 Phase 3 trial • 631 Patients • NCT03745638

Upper respiratory tract infection

Nasopharyngitis

Headache

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Ruxolitinib 0.75% Cream BID

Vehicle Cream BID

Ruxolitinib 1.5% Cream BID

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ruxolitinib 1.5% CreamExperimental Treatment1 Intervention

Participants apply ruxolitinib 1.5% cream topically to the affected areas as a thin film BID for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks.

Group II: Vehicle CreamPlacebo Group1 Intervention

Participants apply ruxolitinib matching vehicle cream topically to the affected areas as a thin film twice daily (BID) for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib Cream

2018

Completed Phase 3

~740

0 / 5Eligibility 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

Prurigo Nodularis (PN) is often treated with Janus kinase (JAK) inhibitors like Ruxolitinib cream, which work by blocking the JAK-STAT signaling pathway involved in the inflammatory response. This inhibition reduces the production of pro-inflammatory cytokines, thereby decreasing inflammation and pruritus (itchiness) associated with PN. This mechanism is crucial for PN patients as it directly targets the underlying inflammatory processes that cause the characteristic nodules and intense itching, providing relief and improving quality of life. Other common treatments for PN may include corticosteroids and immunomodulators, which also aim to reduce inflammation and immune response.

Pimecrolimus 1 percent cream and pulsed dye laser in treatment of a patient with reticular erythematous mucinosis syndrome.