Dupilumab for Itchy Skin Diseases

Overseen By Amy Paller

Age: Any Age

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northwestern University

Must not be taking: Immunosuppressives, Biologics, Retinoids, others

Disqualifiers: Ichthyosis vulgaris, Active infections, Malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 16 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Severe itch is a common symptom of many genetic skin disorders and leads to a negative impact on patient quality of life. The investigators hypothesize that: a) intervention with dupilumab will improve itch in patients with pruritic genetic inflammatory skin disorders, even those not recognized to be Th2-driven; and b) the administration of dupilumab will be well-tolerated, regardless of underlying genetic skin disorder. The total clinical study duration will be 26 months (104 Weeks). The treatment period will include a 16-week open-label phase and a 20-month long-term extension phase for those who qualify and wish to continue.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop certain medications. You must stop using immunosuppressive/immunomodulating drugs, systemic anti-inflammatory medication, or phototherapy at least 4 weeks before the trial. Other biologics must be stopped within 5 half-lives or 16 weeks before the trial. Topical or systemic retinoids and topical anti-inflammatory agents must be started at least 4 weeks before the trial and continued throughout. Consult with the study investigator for specific guidance.

What safety data is available for Dupilumab?

Dupilumab, also known as Dupixent, has been associated with several adverse effects. Commonly reported side effects include local injection site reactions, conjunctivitis, headache, and nasopharyngitis. Ocular adverse reactions are notable, with a prevalence of 5-37% in patients treated for atopic dermatitis. Rare side effects include alopecia areata and cicatricial ectropion. Safety updates emphasize the risk of ocular adverse reactions and the need for prompt management. ^{1 2 3 4 5}

Is the drug Dupilumab a promising treatment for itchy skin diseases?

Yes, Dupilumab is a promising drug for treating itchy skin diseases like atopic dermatitis. It works by blocking certain signals in the body that cause inflammation, helping to control symptoms in people whose conditions are not managed well by other treatments. ^{2 5 6 7 8}

What data supports the idea that Dupilumab for Itchy Skin Diseases is an effective treatment?

The available research shows that Dupilumab is effective for treating moderate-to-severe atopic dermatitis, a type of itchy skin disease. It was first approved in the USA for adults whose condition isn't well-controlled by other treatments. While some patients experience eye-related side effects, the drug is still considered effective for those with severe symptoms. Dupilumab is also being tested for other conditions like asthma and nasal polyps, indicating its potential broader effectiveness. ^{2 5 6 7 8}

Who Is on the Research Team?

Amy Paller

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for individuals over 6 months old with severe itch due to genetic skin disorders, who have an average itch score of ≥4. Participants must not have ichthyosis vulgaris as the only disorder, no recent serious infections or malignancies, and should not be on certain medications like biologics or immunosuppressants recently.

Inclusion Criteria

Subject, parent/caregiver or legal guardians, as appropriate, are able to understand and complete the study requirements and study-related questionnaires

I have had an average itchiness of 4 or more, with it reaching at least 5 at its worst in the past week.

I am older than 6 months.

Exclusion Criteria

I am under 6 months old.

I can give my own consent or have someone legally allowed to do so if I'm under 18.

I haven't used certain medications, including steroids or immunosuppressants, within the last 4 weeks or longer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dupilumab during a 16-week open-label phase to assess changes in itch

16 weeks

Long-term extension

Participants who qualify and wish to continue receive dupilumab for an additional 20 months

20 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab

Trial Overview The study tests Dupilumab's effectiveness in reducing itch in various pruritic genetic inflammatory skin conditions. It includes a 16-week open-label phase followed by a long-term extension up to 26 months for those responding positively and willing to continue.

How Is the Trial Designed?

Group I: Open-Label Dupilumab Experimental Treatment 1 Intervention

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?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

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]

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 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 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 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 46 adult patients with moderate-to-severe atopic dermatitis treated with dupilumab, 34.8% experienced ocular adverse events (OAEs), primarily mild to moderate dry eye disease and superficial punctate keratitis.

Patients with pre-existing conditions such as dry eye disease, eyelid eczema, or high IgE levels were more likely to develop OAEs, suggesting that these factors should be considered before starting dupilumab treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for dupilumab associated ocular adverse events: a real-life prospective study. Touhouche, AT., Cassagne, M., Bérard, E., et al.[2021]

Citations

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

Dupilumab: First Global Approval. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

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

Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. [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. England pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for dupilumab associated ocular adverse events: a real-life prospective study. [2021]