Dupilumab for Chronic Itch

Recruiting at 79 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Disqualifiers: Prurigo nodularis, Atopic dermatitis, Psoriasis, 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: 6

Duration: 24 weeks

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called dupilumab, an injectable medication, to determine its effectiveness in reducing chronic itch caused by lichen simplex chronicus (LSC). Participants will receive injections of either the actual treatment or a placebo, a non-active substance. The trial seeks individuals who have experienced moderate-to-severe LSC for at least six months, with a history of intense itching and no relief from other treatments. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants the opportunity to contribute to the development of a promising new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions a 'washout period' for those who have had systemic treatment for LSC in the past 6 months. It's best to discuss your specific medications with the trial team.

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

Research has shown that dupilumab is generally safe for people. It treats conditions like eczema and asthma, which involve certain types of inflammation. In these studies, most participants did not experience serious side effects.

For example, one study with adults who had moderate-to-severe eczema found that 85% of patients had good results with dupilumab and did not experience severe side effects. Another study found that dupilumab is safe for treating prurigo nodularis, a skin condition that causes itchy bumps.

Overall, these findings suggest that dupilumab is safe for treating chronic itch, with no serious safety concerns reported in past research. However, like any treatment, some people might experience mild side effects. It's always important to discuss potential risks with a healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Dupilumab is unique because it targets the IL-4 and IL-13 pathways, which play a key role in chronic itch. Unlike traditional treatments that often focus on symptom relief through antihistamines or corticosteroids, Dupilumab addresses the underlying inflammation more directly. Researchers are excited because it offers a new mechanism of action that could provide relief for patients who don't respond well to existing therapies.

What evidence suggests that dupilumab might be an effective treatment for chronic itch?

Research has shown that dupilumab, which participants in this trial may receive, helps reduce chronic itching. In one study, 41% of adults using dupilumab experienced a significant reduction in itchiness, compared to only 12% of those taking a placebo. Another review found that dupilumab also improved symptoms in skin conditions like prurigo nodularis, which causes long-lasting itch. These findings suggest that dupilumab can greatly relieve symptoms for people with conditions that cause persistent itching. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with Lichen Simplex Chronicus (LSC) who've had it for at least 6 months, have severe skin lesions, and experience chronic itching. Participants must have tried and failed a course of topical treatments or be unable to use them. They should also practice appropriate contraception.

Inclusion Criteria

I am using effective birth control methods.

I have at least one severe skin lesion.

I have at least one lesion in the genital or anal area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dupilumab or placebo subcutaneous injections for the treatment of pruritus in Lichen Simplex Chronicus

24 weeks

6 visits (in-person)

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 study compares the effects of Dupilumab injections versus placebo on reducing itchiness in LSC patients over a period of up to 24 weeks, followed by a 12-week observation phase. The participants will visit the clinic six times throughout the study.

How Is the Trial Designed?

Group I: Dupilumab Experimental Treatment 1 Intervention

Dupilumab subcutaneous injection as per protocol

Group II: Placebo Placebo Group 1 Intervention

Placebo subcutaneous injection as per protocol

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

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Published Research Related to This Trial

Dupilumab, a monoclonal antibody that inhibits the Th2 signaling pathway, is used to treat atopic dermatitis but can lead to the development of psoriasis in some patients, as seen in a case study of a 40-year-old man.

In this case, the abrupt discontinuation of oral steroid therapy alongside dupilumab treatment was identified as potential triggers for the onset of psoriasis, highlighting the need for careful management when using this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psoriasis in dupilumab-treated atopic dermatitis]. Senner, S., Eicher, L., Aszodi, N., 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]

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 significantly improved clinical scores for atopic dermatitis (AD) in 175 adults over 48 weeks, reducing both the severity of eczema (measured by EASI) and itch intensity (measured by VAS).

The treatment also led to a decrease in serum biomarkers such as total IgE, LDH, and eosinophil count, indicating its efficacy in managing both symptoms and underlying inflammatory processes associated with AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab Treatment Efficacy and Impact on Clinical Scores, Serum Biomarkers, and Itch in Adult Patients with Atopic Dermatitis: A Retrospective Analysis. Rossi, M., Bettolini, L., Artelli, GL., 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]

In a study of 128 patients receiving dupilumab for atopic dermatitis over an average of 14.9 months, the treatment was found to be well-tolerated, with most side effects being mild and not requiring discontinuation.

The most common side effects included head and neck dermatitis (19.5%), conjunctivitis (15.6%), and skin issues like erythema and dryness of eyes, indicating that while side effects do occur, they are generally manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term real-world experience of the side effects of dupilumab in 128 patients with atopic dermatitis and related conditions aged 6 years and above: Retrospective chart analysis from a single tertiary care center. Parmar, NV., Abdula, MA., Al Falasi, A., et al.[2022]

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 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]

Dupilumab significantly reduces chronic pruritus in patients with chronic prurigo (CP) and chronic idiopathic pruritus (CIP), with 89% of CP patients experiencing a reduction in itch severity (NRSI >4) and a mean time to first improvement of about 5 weeks.

The treatment is generally safe, with no serious adverse events reported; however, patients with a history of atopy may experience less efficacy and more side effects, particularly mild conjunctivitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of dupilumab in chronic prurigo and chronic idiopathic pruritus: a systematic review of current evidence and analysis of response predictors. Gael, M., Adam, T., Mariano-Bourin, M., 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02277769

NCT02277769 | Study of Dupilumab (REGN668/ ... This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate ...

2. 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.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1314768

Dupilumab Treatment in Adults with Moderate-to-Severe ... The results of the 12-week study of dupilumab monotherapy reproduced and extended the 4-week findings: 85% of patients in the dupilumab group, ...

4. investor.regeneron.com investor.regeneron.com/news-releases/news-release-details/sanofi-and-regeneron-report-positive-proof-concept-data

Sanofi and Regeneron Report Positive Proof-of-Concept ... Treatment with four weekly subcutaneous injections of dupilumab at either 150 milligrams (mg) or 300mg per week, significantly improved the signs and symptoms ...

5. 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)

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02260986

NCT02260986 | Study to Assess the Efficacy and Long- ... The Safety Data of Dupilumab for the Treatment of Moderate-to-Severe Atopic Dermatitis in Infants, Children, Adolescents, and Adults. Am J Clin Dermatol ...