Dupilumab for Itching

Recruiting at 166 trial locations

Overseen By Trial Transparency email recommended (Toll free number for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Must be taking: Non-sedative antihistamines

Must not be taking: Antiparasitics, Systemic antibiotics

Disqualifiers: HIV, Severe renal failure, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks (Study A) or 12 weeks (Study B)

284 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively dupilumab (an injectable medication) relieves itching in individuals who have experienced chronic itching of unknown cause for at least six months. Participants will receive either dupilumab or a placebo, along with a non-drowsy antihistamine and moisturizer, for 24 weeks. This trial is ideal for those with severe, persistent itching affecting areas like the legs, arms, or trunk, especially if previous treatments have provided little relief. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, you will be required to take a non-sedative antihistamine and a moisturizer during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dupilumab is generally safe. In studies involving individuals with skin conditions like atopic dermatitis, dupilumab maintained a good safety record. Most side effects were mild or moderate, such as dry eyes or injection site reactions, while serious side effects were rare.

One study found that people with eczema who used dupilumab improved without needing steroids, which are often used to manage symptoms. This finding suggests dupilumab might be a safer long-term option for some individuals.

Although there is less information on its use in people with certain health issues, like heart disease or cancer, current data suggests that dupilumab is safe for most individuals. It is important to consult a doctor before joining a trial to determine if this treatment is appropriate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for itching primarily rely on topical corticosteroids or oral antihistamines to manage symptoms. However, Dupilumab is unique because it targets the immune response directly by blocking the IL-4 and IL-13 signaling pathways, which are key drivers of inflammation and itch in conditions like eczema. This mechanism of action offers a more targeted approach compared to traditional treatments. Additionally, Dupilumab is administered via a subcutaneous injection every two weeks, which can provide consistent relief without the need for daily medication. Researchers are excited about Dupilumab because it has the potential to offer more sustained and effective relief for patients with chronic itching conditions.

What evidence suggests that this trial's treatments could be effective for CPUO?

Research has shown that dupilumab, which participants in this trial may receive, can help reduce itching in various skin conditions. One study found that 41% of adults with moderate-to-severe atopic dermatitis experienced a significant decrease in itch after using dupilumab, compared to only 12% with a placebo. Another study on prurigo nodularis found that dupilumab helped improve itch symptoms. These findings suggest that dupilumab may effectively reduce severe itching in conditions like chronic pruritus of unknown origin (CPUO). ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My worst itch score has been 7 or more for the past two weeks.

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

I have had chronic itching for at least 6 months.

Exclusion Criteria

I haven't had cancer, except for certain skin cancers or cervical cancer that's been fully treated, in the last 5 years.

I have not needed antibiotics or antivirals for an infection in the last 2 weeks.

I might have a parasite infection or have taken antiparasitic drugs recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Run-in

Participants with severe pruritus enter a 4-week run-in period with a non-sedative antihistamine and an emollient

4 weeks

Treatment

Participants are randomized to receive either dupilumab or placebo for 24 weeks (Study A) or 12 weeks (Study B) in addition to their antihistamine and emollient regimen

24 weeks (Study A) or 12 weeks (Study B)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Dupilumab Experimental Treatment 2 Interventions

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

Group II: Placebo Placebo Group 2 Interventions

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

Dupilumab is already approved in United States, European Union for the following indications:

Approved in United States as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Approved in European Union as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

In a study of 100 patients with atopic dermatitis, 36% of those treated with dupilumab developed ocular diseases, significantly higher than the 10% in the reference group.

Severe allergic conjunctivitis and blepharitis were notably more common in the dupilumab group, with 30% and 22% of patients affected, respectively, indicating a need for careful monitoring and potential ophthalmologist consultation before starting treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. Barbé, J., Poreaux, C., Remen, T., et al.[2021]

In a case study involving 3 patients with severe itching due to cancer, dupilumab treatment resulted in immediate and complete relief of pruritus after just a few doses, demonstrating its efficacy.

Dupilumab was well-tolerated with no significant adverse effects reported, suggesting it is a safe option for treating intractable malignancy-associated pruritus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab for cancer-associated refractory pruritus. Talmon, A., Elias, S., Rubin, L., et al.[2023]

In a study of 818 adults with moderate-to-severe atopic dermatitis treated with dupilumab for at least 16 weeks, 12% of patients successfully spaced their doses or withdrew treatment while still maintaining effectiveness.

Key predictors for successful dose spacing or treatment withdrawal included having non-cutaneous atopic manifestations, a prurigo nodularis phenotype, and being older at the start of treatment, suggesting specific patient profiles can benefit from adjusted treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. Chiricozzi, A., Dal Bello, G., Gori, N., et al.[2023]

Dupilumab (Dupixent) has been associated with a risk of ocular adverse reactions, highlighting the importance of monitoring patients for eye-related side effects during treatment.

Prompt management of any ocular issues is essential for patients receiving dupilumab, ensuring their safety and well-being while benefiting from the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety update: dupilumab and ocular adverse reactions. [2022]

Dupilumab is a monoclonal antibody that targets the IL-4 receptor, effectively inhibiting the action of IL-4 and IL-13, which are key players in allergic diseases.

It received its first approval in March 2017 for treating moderate-to-severe atopic dermatitis in adults who do not respond well to topical treatments, and is also being developed for asthma, nasal polyps, and eosinophilic esophagitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab: First Global Approval. Shirley, M.[2022]

Dupilumab is an effective treatment for type 2 inflammatory diseases like atopic dermatitis, asthma, and nasosinusal polyposis, as it inhibits the IL-4 receptor, blocking the action of key cytokines involved in these conditions.

The drug has a favorable safety profile, with few and reversible side effects, making it a promising option for patients who do not respond well to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dupilumab: beyond atopic dermatitis, off-label use in dermatology]. Russo, G., Laffitte, E.[2023]

Dupilumab is an effective treatment for atopic dermatitis, showing significant improvements in skin symptoms and overall disease control in clinical trials.

The medication works by inhibiting specific pathways in the immune system, which helps reduce inflammation and alleviate the symptoms of atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. D'Ippolito, D., Pisano, M.[2020]

In a phase III study involving 165 adult Chinese patients with moderate-to-severe atopic dermatitis, dupilumab significantly improved skin condition, with 26.8% of patients achieving the primary efficacy endpoint compared to only 4.8% in the placebo group (P < 0.001).

Dupilumab demonstrated a favorable safety profile, although there was a higher incidence of conjunctivitis and injection site reactions compared to placebo, indicating that while effective, monitoring for these side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of dupilumab in Chinese patients with moderate-to-severe atopic dermatitis: a randomized, double-blind, placebo-controlled study. Zhao, Y., Wu, L., Lu, Q., et al.[2022]

Dupilumab, a treatment for atopic dermatitis, effectively improved skin lesions in a patient but also caused unexpected facial erythema and desquamation, highlighting potential adverse effects.

The case suggests that while dupilumab is beneficial for atopic dermatitis, it may trigger or exacerbate conditions like systemic lupus erythematosus (SLE), indicating the need for careful monitoring of patients during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facial erythema after the treatment of dupilumab in SLE patient. Jang, DH., Lee, JI., Bae, JY., et al.[2022]

Dupilumab, a monoclonal antibody approved by the FDA in 2017, effectively treats moderate to severe atopic dermatitis by inhibiting IL-4 and IL-13 signaling, providing an alternative for patients not responding to topical therapies.

While dupilumab is generally effective, it can cause adverse effects such as injection site reactions and conjunctivitis, with rare cases like alopecia areata reported, highlighting the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab side effect in a patient with atopic dermatitis: a case report study. Albader, SS., Alharbi, AA., Alenezi, RF., et al.[2020]

In a study of 62 adult patients treated with dupilumab for atopic dermatitis, 6% developed head and neck dermatitis, a side effect not previously reported in clinical trials.

The dermatitis typically appeared 8 to 24 weeks after starting treatment and resolved within 8 to 12 weeks, suggesting a potential toxic effect of dupilumab that warrants further investigation into its underlying causes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab facial redness: histologic characterization on a series of four cases. Dybała, A., Sernicola, A., Gomes, V., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9895771/

Dupilumab for the treatment of prurigo nodularis The objective of this study was to systematically review dupilumab-related treatment outcomes in prurigo nodularis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02277769

NCT02277769 | Study of Dupilumab (REGN668/ ... ... studies) . Completed. Study of Dupilumab (REGN668/​SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (SOLO 2).

3. dupixenthcp.com dupixenthcp.com/atopicdermatitis/efficacy-safety/pruritus-nrs-clinical-trial

Adult Peak Pruritus NRS Efficacy Results 41 % of adults treated with DUPIXENT (n=213) achieved ≥4-point reduction in Peak Pruritus NRS vs 12% with placebo at Week 16 in SOLO 1 (n=212; P<0.001)

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02260986

NCT02260986 | Study to Assess the Efficacy and Long- ... The primary objective of the study was to demonstrate the efficacy of Dupilumab administered concomitantly with topical corticosteroid (TCS) through Week 16 ...

5. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2012-003651-11/results

EudraCT Number 2012-003651-11 - Clinical trial results To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult patients with moderate-to-severe AD. Protection of trial subjects.

6. annallergy.org annallergy.org/article/S1081-1206(25)00203-0/fulltext

Patient outcomes and safety of combination biologic ... 1. A 56-y-old man saw significant eczema improvement within 3 mo of adding dupilumab, discontinued corticosteroids, and reported dry eyes. 2. A ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06087627/a-non-interventional-study-to-describe-the-dupilumab-long-term-treatment-safety-and-patient-reported-outcomes-in-chronic-nodular-prurigo-prurigo-nodularis-in-clinical-routine

A Non-interventional Study to Describe the Dupilumab ... The main symptom is uncontrollable itching leading to prolonged, repetitive, and uncontrollable rubbing, scratching which in turn causes ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01639040

NCT01639040 | Study to Assess the Safety of Dupilumab ... The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to- ...