Dupilumab for Chronic Itch

Recruiting at 50 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

Trial Summary

What is the purpose of this trial?

This is a parallel, Phase 3, 2-arm study for treatment. The purpose of this study is to measure improvement in pruritus with dupilumab subcutaneous injections compared with placebo injections in male and female participants aged at least 18 years with LSC. Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The follow-up duration after treatment will be 12 weeks. The number of visits will be 6.

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, 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.

What data supports the effectiveness of the drug Dupilumab for treating chronic itch?

Dupilumab has shown significant effectiveness in reducing chronic itch, particularly in conditions like atopic dermatitis, where it greatly reduces itch severity. In a study, 89% of patients experienced a significant reduction in itch severity, and 83% noticed improvement within four weeks of starting treatment. ^{1 2 3 4 5}

Is dupilumab generally safe for humans?

Dupilumab is generally considered safe, but common side effects include injection site reactions, conjunctivitis (eye inflammation), and nasopharyngitis (cold-like symptoms). Some patients may experience head and neck dermatitis, facial redness, or rare conditions like alopecia areata (hair loss) and cicatricial ectropion (eyelid turning outwards). Most side effects are mild and do not require stopping the treatment. ^{1 6 7 8 9}

How is the drug Dupilumab unique for treating chronic itch?

Dupilumab is unique because it targets and blocks the activity of specific proteins (IL-4 and IL-13) involved in the inflammation process that causes itching, which is different from other treatments that may not specifically target these pathways. ^{1 3 4 5 10}

Eligibility Criteria

This trial is for adults with Lichen Simplex Chronicus (LSC) who have at least two lesions, one severe lesion, and a history of the condition for six months or more. Participants must have tried and failed a course of topical treatments within the last six months or be unable to use them. They should not be on systemic treatments other than antihistamines.

Inclusion Criteria

I am at least 18 years old or the legal age of consent where the study is conducted.

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

I have at least two tumors, with one being 3 cm or larger.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dupilumab or placebo subcutaneous injections to measure improvement in pruritus

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Dupilumab

Trial Overview The study compares Dupilumab injections against placebo in treating pruritus (itchiness) associated with LSC. It's a Phase 3 trial where participants will receive treatment for up to 24 weeks and then be followed up for another 12 weeks over six visits.

Participant Groups

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

Findings from Research

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 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]

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]

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, 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]

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, 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 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 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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Dupilumab: First Global Approval. [2022]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Dupilumab for cancer-associated refractory pruritus. [2023]

4. New Zealand 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. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

[Psoriasis in dupilumab-treated atopic dermatitis]. [2020]

6. England pubmed.ncbi.nlm.nih.gov

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

7. New Zealand pubmed.ncbi.nlm.nih.gov

Dupilumab side effect in a patient with atopic dermatitis: a case report study. [2020]

8. United States 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Dupilumab facial redness: histologic characterization on a series of four cases. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. [2021]