What side effects are associated with this type of intervention?

Common treatments for itching, particularly those similar to Dupilumab, include biologics that target specific immune pathways. Dupilumab, which inhibits IL-4 and IL-13 signaling, has been associated with side effects such as injection site reactions, conjunctivitis, and eosinophilia. Other biologics, like those targeting IL-17 or IL-23, may cause similar immune-related side effects, including upper respiratory infections, headache, and potential exacerbation of pre-existing conditions. It is important to monitor for these side effects and discuss them with a healthcare provider.

What prior FDA approvals exist?

Dupilumab, an IL-4 and IL-13 inhibitor, has been approved by the FDA for the treatment of moderate-to-severe atopic dermatitis, which often includes severe itching. Other treatments for itching that have been studied include nemolizumab, an anti-IL-31 antibody, which has shown efficacy in controlling pruritus associated with atopic dermatitis. Additionally, JAK inhibitors like upadacitinib and baricitinib have been explored for their potential in reducing itching in atopic dermatitis patients.

What other types of research exist?

Promising novel alternatives to Dupilumab for treating itching in 2024 include: 1) Fezakinumab, an IL-22 antagonist, which has shown efficacy in reducing pruritus in atopic dermatitis patients. 2) Brodalumab, an IL-17 receptor antagonist, which has demonstrated effectiveness in various dermatological conditions including psoriasis and may offer benefits for pruritus. 3) Naltrexone, an oral opiate receptor antagonist, which has been effective in treating refractory pruritus in various conditions. These alternatives provide different mechanisms of action and may be suitable for patients who do not respond to or cannot use Dupilumab.

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Monoclonal Antibodies

Dupilumab for Itching

Phase 3

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

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

Must have

Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 90 years of age inclusive, at the time of signing the informed consent.

Participants must have a history of severe itch and a worst itch score of ≥7 at screening on the WI-NRS (score scale ranges from 0 to 10; higher score indicates worse itch) and Patient global impression of severity (PGIS) of pruritus scored "severe" at screening.

Must not have

Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.

HIV infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 36

Awards & highlights

Pivotal Trial

Summary

This trial tests a medication that reduces skin inflammation and itching in adults with severe, unexplained itching. It works by blocking proteins that cause these symptoms. The medication has shown promise in treating conditions like atopic dermatitis and asthma.

Who is the study for?

Adults aged 18-90 with severe, chronic itching of unknown origin that affects at least two body areas (legs, arms, or trunk) and have not found relief from previous treatments. Participants must score 'severe' on itch severity scales and be in good health otherwise. Those with certain infections, immune deficiencies, severe kidney failure, hypersensitivity to antihistamines or a history of cancer within the last five years are excluded.

What is being tested?

The trial is testing Dupilumab's effectiveness for treating chronic itching without a known cause over a period of either 12 or 24 weeks. It involves two parallel studies where participants also use non-sedative antihistamines and moisturizers. They're randomly assigned to receive either Dupilumab or a placebo in addition to their current regimen.

What are the potential side effects?

While specific side effects for this trial aren't listed here, common side effects of Dupilumab may include injection site reactions (like redness), eye inflammation or irritation, cold sores in your mouth or throat area.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 90 years old.

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I have severe itching with a score of 7 or more and consider my itching to be severe.

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My severe itching has not improved with past treatments.

Exclusion Criteria

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

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I have previously participated in a dupilumab study or used dupilumab.

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I am HIV positive.

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I am on dialysis for severe kidney failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 36 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by ≥4 from baseline to Week 24

Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12

Secondary study objectives

Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 12

Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 24

Study A: Absolute change from baseline in weekly average of daily sleep disturbances NRS at Week 12

+30 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367

Conjunctivitis

Headache

Dermatitis Atopic

Nasopharyngitis

Accidental Overdose

Drug Hypersensitivity

Polyarthritis

100%

80%

60%

40%

20%

Study treatment Arm

DB Period: Placebo

DB Period: Dupilumab

OLE Period: Placebo/Dupilumab

OLE Period: Dupilumab/Dupilumab

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: DupilumabExperimental Treatment3 Interventions

Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) on top of non-sedative antihistamine and moisturizer

Group II: PlaceboPlacebo Group3 Interventions

Loading dose administered SC, followed by SC Q2W on top of non-sedative antihistamine and moisturizer

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dupilumab

2017

Completed Phase 4

~11960

Moisturizer

2008

Completed Phase 4

~300

0 / 6Eligibility 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

Common treatments for itching, such as Dupilumab, work by targeting specific cytokines and immune pathways involved in inflammation and pruritus. Dupilumab inhibits IL-4 and IL-13 signaling, reducing inflammation and itch. Other treatments, like JAK inhibitors, interfere with the JAK-STAT pathway, and anti-IL-31 antibodies block IL-31, a cytokine directly linked to itching. These mechanisms are important for patients to understand as they help in choosing the most effective treatment based on the cause of their itching.