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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether dupilumab, a medication, can help people with alopecia areata (AA), a condition causing hair loss on more than half of the scalp. The trial compares weekly injections of dupilumab to a placebo over 48 weeks to determine which works better. All participants will eventually receive dupilumab for a total of 96 weeks. Individuals with moderate to severe AA for at least six months, some hair regrowth in the last seven years, and a personal or family history of allergies (atopy) might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

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

Research has shown that dupilumab is generally safe for patients. In studies involving individuals with moderate-to-severe atopic dermatitis, most side effects were mild, and no serious side effects were directly linked to the treatment.

Another study with a small group of patients with alopecia areata found similar results. The treatment was well-tolerated, and no severe side effects occurred.

Dupilumab works by blocking certain proteins in the body that cause inflammation. The FDA has already approved it for treating other conditions, suggesting its safety. However, individual experiences may vary, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alopecia areata?

Dupilumab is unique because it targets the immune pathways involved in alopecia areata by inhibiting interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling. Unlike standard treatments that often involve corticosteroids or immunosuppressants, dupilumab specifically addresses the inflammatory components of the disease, offering a potentially more targeted approach. Researchers are excited about dupilumab because it has already been successful in treating other inflammatory conditions like eczema, suggesting it might offer a new, effective option for those struggling with hair loss due to alopecia areata.

What evidence suggests that dupilumab might be an effective treatment for alopecia areata?

Research has shown that dupilumab, which participants in this trial may receive, may help treat alopecia areata (AA), a condition that causes hair loss. In one study, 70% of patients saw their hair grow back, with more colored hair appearing over time. Another report described a case where nearly all hair grew back within 8 months of starting dupilumab, and this improvement continued with long-term use. These findings suggest that dupilumab could be effective for AA, especially for those who have experienced hair regrowth before. ^{1 3 5 6 7}

Who Is on the Research Team?

Emma Guttman-Yassky

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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, 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]

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]

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]

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]

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]

Citations

1. tandfonline.com tandfonline.com/doi/full/10.1080/09546634.2024.2312245

Dupliumab therapy for alopecia areata: a case series and ... Notably, seven patients (70%) had white hair regrowth, with the white hair slowly decreasing over time and the proportion of pigmented black ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12293969/

Alopecia Areata Associated with Dupilumab The primary outcome assessed was the development of AA. As dupilumab can take up to 16 weeks to fully take effect, outcomes within 16 weeks of ...

3. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/dupilumab-regeneron-pharmaceuticals-alopecia-areata-likelihood-of-approval/

Dupilumab by Regeneron Pharmaceuticals for Alopecia ... According to GlobalData, Phase II drugs for Alopecia Areata have a 48% phase transition success rate (PTSR) indication benchmark for progressing ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03359356

Treatment of Alopecia Areata (AA) With Dupilumab in ... Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can fall out on the scalp or elsewhere on the face and body.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9235915/

Long-Term Efficacy of Dupilumab in Alopecia Areata - PMC Within 8 months of starting dupilumab, the patient had almost complete regrowth of his scalp hair, as seen in Figure 2B. After almost 3 years on this regimen, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02277769

NCT02277769 | Study of Dupilumab (REGN668/ ... Laboratory safety of dupilumab in moderate-to-severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY ...

7. annallergy.org annallergy.org/article/S1081-1206(25)00203-0/fulltext

Patient outcomes and safety of combination biologic ... Combination biologic therapy with dupilumab seems to be well-tolerated, with most adverse effects being mild and no severe events directly attributed to ...