Daxdilimab for Alopecia Areata

No longer recruiting at 24 trial locations

Overseen By Horizon Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Amgen

Must not be taking: Steroids, JAK inhibitors

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test Daxdilimab, a new treatment for individuals with moderate to severe Alopecia Areata (AA), a condition causing significant hair loss on the scalp. Researchers seek to evaluate the effectiveness, safety, and tolerability of Daxdilimab. Participants should have lost between 50% and 95% of their scalp hair due to AA, with the current episode lasting more than 3 months but less than 7 years. The study seeks individuals who haven't experienced significant hair regrowth recently and are willing to maintain their current hairstyle and color during the trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications that might affect hair regrowth, such as steroids, minoxidil, and some topical treatments, at least 4 weeks before starting the trial. Other medications like biologics or immunosuppressants need to be stopped 8 weeks or more before the trial, depending on the specific drug.

Is there any evidence suggesting that Daxdilimab is likely to be safe for humans?

Research indicates that specific safety information for Daxdilimab in people with alopecia areata is not yet available. However, Daxdilimab is in a Phase 2 trial, which means smaller groups have already tested it for safety. Treatments in this phase typically demonstrate some level of safety and are generally well-tolerated.

Daxdilimab targets certain immune cells. Similar treatments have been well-tolerated in other conditions. While this does not guarantee safety, it suggests that Daxdilimab might be safe for people. Researchers will closely monitor trial participants to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for alopecia areata, which typically involve corticosteroids or topical immunotherapy, Daxdilimab is unique because it works by targeting the immune system differently. This treatment is a monoclonal antibody that specifically inhibits a protein involved in the inflammatory process, potentially reducing hair loss by directly addressing the immune response. Researchers are excited about Daxdilimab because it offers a novel approach that might provide more targeted and effective results, potentially with fewer side effects compared to current options.

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

Research has shown that Daxdilimab, the treatment being tested in this trial for alopecia areata (AA), works by adjusting the immune system. This method resembles other successful treatments, such as Dupilumab, which has helped some patients fully regrow their hair over time. Early results suggest that new drugs like Daxdilimab could be promising for treating severe AA. Although specific data on Daxdilimab's effectiveness is still being gathered, its mechanism offers hope for reducing hair loss by addressing the immune system's role. ^{2 3 6 7 8}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with moderate-to-severe alopecia areata, having experienced significant hair loss (50-95%) without regrowth for the past 6 months to less than 7 years. Participants must be willing to maintain their current hairstyle and color throughout the study.

Inclusion Criteria

Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the trial.

Willing and able to give informed consent.

You don't have any current or recent significant regrowth of the condition being studied.

Exclusion Criteria

You have tested positive for hepatitis B or C.

Individuals involved in the conduct of the trial, their employees, or immediate family members

You have ongoing skin conditions or signs of inflammation on your skin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive daxdilimab administered subcutaneously over 32 weeks

32 weeks

Nine sets of Daxdilimab injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Daxdilimab

Trial Overview The trial is testing Daxdilimab's effectiveness and safety in individuals with alopecia areata. It will evaluate how well it works, its tolerability, how the body processes it (pharmacokinetics), and how it affects the body's response (pharmacodynamics).

How Is the Trial Designed?

Group I: Daxdilimab Experimental Treatment 1 Intervention

Nine sets of Daxdilimab injections over a total of 32 weeks.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Horizon Therapeutics Ireland DAC

Lead Sponsor

Trials

21

Recruited

2,500+

Published Research Related to This Trial

JAK inhibitors represent a significant advancement in the treatment of moderate-to-severe alopecia areata (AA), a condition that previously had limited treatment options.

Phase 3 clinical trial data supports the efficacy of JAK inhibitors in treating AA, highlighting the importance of understanding the differences among various JAK inhibitors for optimal patient selection and safety considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Janus kinase inhibitors for alopecia areata. King, BA., Craiglow, BG.[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]

A systematic review of 28 studies involving 1719 patients found that JAK-inhibitors for alopecia areata are generally well-tolerated, with most adverse events being mild and a low withdrawal rate due to side effects (1.6% compared to 2.2% for placebo).

Common adverse events included laboratory abnormalities (40.1%), respiratory issues (20.8%), and skin reactions (17.2%), but no fatal outcomes were reported, indicating a favorable safety profile for these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in patients treated with Jak-inhibitors for alopecia areata: A systematic review. Sechi, A., Song, J., Dell'Antonia, M., et al.[2023]

Baricitinib, an oral JAK inhibitor, is the first approved treatment for adults with severe alopecia areata (AA) and has shown consistent benefits in hair regrowth compared to placebo in multiple randomized controlled trials.

The review highlighted that while baricitinib has robust evidence supporting its efficacy, many other treatments for moderate-to-severe AA lack thorough evaluation in clinical trials, leading to inconsistent data on their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatments for Moderate-to-Severe Alopecia Areata: A Systematic Narrative Review. Egeberg, A., Linsell, L., Johansson, E., et al.[2023]

Tofacitinib demonstrated a high effectiveness and acceptable safety profile in treating alopecia areata, with a complete response rate of 33.8% after 24 weeks in a cohort of 80 patients.

The study, which included 126 patients treated over a median duration of 23 weeks, showed a good drug retention rate, with 90% of patients remaining on the medication after 12 weeks, indicating its potential for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Survival and Long-term Outcome of Tofacitinib in Patients with Alopecia Areata: A Retrospective Study. Huang, J., Deng, S., Li, J., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05368103

NCT05368103 | Study of DAXDILIMAB for the Treatment ... The purpose of this study is to assess the preliminary efficacy, safety, tolerability, PK, and PD of Daxdilimab in participants with moderate to severe AA, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36408593/

Emerging drugs for the treatment of alopecia areata New and very effective drugs have become available for the treatment of severe AA, and many others are expected soon.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/03/NCT05368103/Prot_000.pdf

HO·RIZON Objective outcome measures: Collecting meaningful data on alopecia areata. J Am Acad Dermatol. 2018;79(3):470-478 e473. 24. Wyrwich KW ...

4. withpower.com withpower.com/trial/phase-2-alopecia-3-2022-c30f8

Daxdilimab for Alopecia Areata · Info for Participants 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 ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ajd.14597?af=R

Systemic Treatment of Moderate to Severe Alopecia Areata ... A SALT score ≤ 10 was achieved by 27.8%–29.9% of participants treated with 4 mg and 14.1%–16.7% of those treated with 2 mg at 52 weeks [3, 5, 47] ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05368103

NCT05368103 | Study of DAXDILIMAB for the Treatment ... The purpose of this study is to assess the preliminary efficacy, safety, tolerability, PK, and PD of Daxdilimab in participants with moderate to severe AA.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10657858/

Inhibition of T-cell activity in alopecia areata - PubMed Central A phase 2 trial assessing the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics of daxdilimab in adults with AA and 50% to 95% scalp hair ...

8. adisinsight.springer.com adisinsight.springer.com/drugs/800045472

Daxdilimab - Horizon Therapeutics - AdisInsight - Springer A subcutaneous injection formulation of daxdilimab (formerly known as VBI 7734), an anti-ILT7 monoclonal antibody, is being developed by Viela Bio (a ...