Dupilumab for Itching

Recruiting in Palo Alto (17 mi)

+135 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

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)

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Dupilumab for itching?

Dupilumab is effective in reducing itching because it blocks certain proteins (IL-4 and IL-13) involved in the itching process, and it is already approved for treating atopic dermatitis, a condition where itching is a major symptom. ^{1 2 3 4 5}

What safety data exists for Dupilumab (Dupixent) in humans?

Dupilumab, used for conditions like atopic dermatitis, has been associated with some side effects, including injection site reactions, conjunctivitis (eye inflammation), headaches, and nasopharyngitis (cold-like symptoms). Some patients have experienced facial redness and neck dermatitis, and there is a risk of ocular (eye-related) adverse reactions, which need prompt management. ^{1 3 6 7 8}

What makes the drug Dupilumab unique for treating itching?

Dupilumab is unique because it is a monoclonal antibody that targets the interleukin-4 receptor, blocking signals from IL-4 and IL-13, which are involved in allergic responses. This mechanism is different from typical treatments that may not specifically target these pathways. ^{1 3 9 10 11}

Research Team

Eligibility Criteria

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 am between 18 and 90 years old.

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

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.

Trial Timeline

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

Treatment Details

Interventions

• Dupilumab (Monoclonal Antibodies)

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.

Participant Groups

Group I: Dupilumab Experimental Treatment 3 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 3 Interventions

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

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

Findings from Research

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]

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]

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 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, 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Dupilumab for cancer-associated refractory pruritus. [2023]

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

Dupilumab: First Global Approval. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for 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. England pubmed.ncbi.nlm.nih.gov

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

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

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. [2023]

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

Facial erythema after the treatment of dupilumab in SLE patient. [2022]

11. England 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. [2022]