Dupilumab for Alopecia Areata

Recruiting at 2 trial locations

Overseen By Natasha A Mesinkovska, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Emma Guttman

Must not be taking: Immunosuppressives, JAK inhibitors

Disqualifiers: Pregnancy, Severe asthma, Infections, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

68 Participants Needed

Trial Summary

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

Yes, you may need to stop certain medications. The trial excludes those who have used systemic immunosuppressive medications within 4 weeks or oral JAK inhibitors within 12 weeks before starting the trial. Also, you should not have used topical corticosteroids, tacrolimus, or pimecrolimus within 1 week before the trial begins.

What data supports the effectiveness of the drug Dupilumab for treating alopecia areata?

Research shows that Dupilumab, originally used for atopic dermatitis, has helped some patients with alopecia areata regrow hair. Several case reports indicate significant hair regrowth in patients with alopecia areata after using Dupilumab. ^{1 2 3 4 5}

Is Dupilumab safe for humans?

Dupilumab has been used safely in humans for conditions like atopic dermatitis, with some reports showing no side effects. However, there have been cases where it may have caused or worsened alopecia areata, suggesting a possible unrecognized adverse effect. ^{1 3 4 5 6}

How does the drug Dupilumab differ from other treatments for alopecia areata?

Dupilumab is unique because it is a biologic drug originally approved for atopic dermatitis that has shown potential in improving alopecia areata by blocking specific immune signals (interleukin-4 and interleukin-13 receptors). Unlike traditional treatments, it is administered as an injection and has been associated with both improvement and reactivation of alopecia, indicating a complex interaction with the condition. ^{1 4 5 6 7}

What is the purpose of this trial?

This is a prospective, randomized, double blind, placebo-controlled clinical trial. The study will take place at 4 sites. This trial will enroll a total of 68 patients with moderate to severe AA (affecting more than 50% of the scalp) at the time of screening with a targeted 54 subjects completers through Week 48. AA subjects must have evidence of hair regrowth within the last 7 years of their last episode of hair loss; and have screening IgE ≥ 200 and/or have personal and/or familial history of atopy. Subjects will be randomized (2:1) to either receive weekly dupilumab or placebo for 48 weeks, with all subjects completing participation through Week 48 receiving an additional 48 weeks of dupilumab (through Week 96).

Research Team

Emma Guttman-Yassky

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

Adults with moderate to severe Alopecia Areata (AA) affecting more than half of the scalp, who have seen hair regrowth in the past 7 years and have a history or family history of allergies. Participants must be healthy overall, not pregnant or breastfeeding, use contraception if applicable, and meet specific blood test criteria. Excluded are those with certain diseases like hepatitis or HIV, recent immunosuppressive treatments, no AA hair regrowth for over 7 years, and other health risks.

Inclusion Criteria

I have lost more than 50% of my scalp hair for over 6 months, or almost all my hair.

I use a condom and an additional barrier method for contraception.

Subject is able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria

I do not have active hepatitis B, C, or HIV.

I have had alopecia areata with no hair regrowth for over 7 years.

I have used creams for skin conditions within the last week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly dupilumab or placebo for 48 weeks

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants receive an additional 48 weeks of dupilumab

48 weeks

Treatment Details

Interventions

• Dupilumab
• Placebo

Trial Overview The trial is testing Dupilumab against a placebo in individuals with AA. It's randomized and double-blind meaning neither participants nor researchers know who gets what treatment. For 48 weeks some will get weekly Dupilumab injections while others get placebos; afterwards all receive Dupilumab for another 48 weeks.

Participant Groups

Group I: Dupilumab Experimental Treatment 1 Intervention

Dupilumab: weekly 300mg SC injections Manufacturer: Regeneron

Group II: Placebo Placebo Group 1 Intervention

Placebo: weekly SC injections of equivalent volume Manufacturer: Regeneron

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?

Emma Guttman

Lead Sponsor

Trials

4

Recruited

190+

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

A 12-year-old boy with severe combined immunodeficiency and severe atopic dermatitis showed excellent clinical improvement after receiving dupilumab, achieving complete remission within a year.

The treatment was well-tolerated with no reported side effects, indicating a favorable safety and efficacy profile for dupilumab in this patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prurigo-like atopic dermatitis in a child with CARD11-associated severe combined immunodeficiency successfully treated with dupilumab. Gualdi, G., Lougaris, V., Amerio, P., et al.[2023]

Dupilumab, a monoclonal antibody approved for atopic dermatitis, shows promise as a potential treatment for patients with alopecia areata (AA), particularly those who have not responded to other treatments.

The study highlights that Dupilumab may induce hair regrowth in patients with alopecia totalis, suggesting its efficacy in managing this autoimmune condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab Induced Hair Regrowth in Alopecia Totalis. Bur, D., Kim, K., Rogge, M.[2023]

Dupilumab, an immune-modulating drug, has shown long-term efficacy in treating alopecia areata in a 16-year-old patient, leading to complete hair regrowth and significant improvement in atopic dermatitis over three years.

This case suggests that dupilumab's mechanism of action, which involves blocking Th2 immune response signaling, may have broader applications in treating autoimmune conditions, although further research is needed to fully understand its effects on alopecia areata.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Efficacy of Dupilumab in Alopecia Areata. Kulkarni, M., Rohan, CA., Travers, JB., et al.[2022]

Dupilumab, a biologic drug used for moderate-to-severe atopic dermatitis, has shown potential in improving alopecia areata, a condition characterized by hair loss.

The case reported indicates significant improvement in alopecia areata symptoms after starting Dupilumab treatment for atopic dermatitis, suggesting a possible beneficial effect of this medication beyond its primary use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of alopecia areata with Dupilumab in a patient with severe atopic dermatitis and review the literature. Magdaleno-Tapial, J., Valenzuela-Oñate, C., García-Legaz-Martínez, M., et al.[2021]

Dupilumab, an interleukin-4 receptor alpha antagonist, has been shown to significantly improve atopic dermatitis (AD).

In addition to its effects on AD, dupilumab treatment has also led to notable resolution of alopecia areata, alopecia universalis, and alopecia totalis, indicating its potential as a treatment for these hair loss conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of atopic dermatitis and alopecia universalis with dupilumab. Alotaibi, L., Alfawzan, A., Alharthi, R., et al.[2022]

A 42-year-old woman with severe atopic dermatitis experienced a reactivation of alopecia areata after starting treatment with dupilumab, a medication for her dermatitis, which had been in remission for over 5 years.

This case suggests that dupilumab may have an unrecognized adverse effect of triggering alopecia areata in patients, highlighting the need for further investigation into its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reactivation of Alopecia Areata After Dupilumab Therapy for Atopic Dermatitis. Carnicle, JM., Hendricks, AJ., Shi, VY.[2022]

In a study analyzing 20,548 adverse event reports related to dupilumab, 462 cases (2.2%) were linked to hair disorders, primarily hair loss, indicating a notable side effect of this medication.

Dupilumab was found to be associated with hair disorders more frequently in women and showed a higher reporting rate in Europe, suggesting a need for further investigation into its effects on hair health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short communication: Comments on hair disorders associated with dupilumab based on VigiBase. Park, S., Park, SH., Byun, YJ., et al.[2022]

References

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

Prurigo-like atopic dermatitis in a child with CARD11-associated severe combined immunodeficiency successfully treated with dupilumab. [2023]

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

Dupilumab Induced Hair Regrowth in Alopecia Totalis. [2023]

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

Long-Term Efficacy of Dupilumab in Alopecia Areata. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Improvement of alopecia areata with Dupilumab in a patient with severe atopic dermatitis and review the literature. [2021]

5. Italy pubmed.ncbi.nlm.nih.gov

Improvement of atopic dermatitis and alopecia universalis with dupilumab. [2022]

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

Reactivation of Alopecia Areata After Dupilumab Therapy for Atopic Dermatitis. [2022]

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

Short communication: Comments on hair disorders associated with dupilumab based on VigiBase. [2022]