Daxdilimab for Alopecia Areata

Recruiting at 22 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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests Daxdilimab, an injectable medication, in people with significant hair loss from Alopecia Areata. The goal is to see if it can safely reduce hair loss by changing how the immune system reacts.

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.

What evidence supports the effectiveness of the drug Daxdilimab for treating alopecia areata?

Research shows that drugs targeting the JAK pathway, like Daxdilimab, can help with hair regrowth in alopecia areata by reducing inflammation and altering immune responses. Similar drugs, such as baricitinib, have shown consistent benefits in clinical trials for severe cases of this condition. ^{1 2 3 4 5}

Is Daxdilimab safe for humans?

There is no specific safety data available for Daxdilimab in the provided research articles. However, similar treatments like JAK inhibitors for alopecia areata have been generally well-tolerated, with most side effects being mild and not life-threatening. ^{6 7 8 9 10}

How is the drug Daxdilimab different from other treatments for alopecia areata?

Daxdilimab is unique because it is a biologic therapy that targets specific immune pathways involved in autoimmune diseases, potentially offering a new approach for treating alopecia areata, which is often challenging to manage with existing treatments. ^{2 4 11 12 13}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

Selective Janus kinase 1 inhibition resolves inflammation and restores hair growth offering a viable treatment option for alopecia areata. [2023]

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

Janus kinase inhibitors for alopecia areata. [2023]

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

Selective inhibition of JAK3 signaling is sufficient to reverse alopecia areata. [2022]

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

Induction of T cell exhaustion by JAK1/3 inhibition in the treatment of alopecia areata. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Treatments for Moderate-to-Severe Alopecia Areata: A Systematic Narrative Review. [2023]

6. France pubmed.ncbi.nlm.nih.gov

Alopecia areata: Recent advances and emerging therapies. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Adverse events in patients treated with Jak-inhibitors for alopecia areata: A systematic review. [2023]

8. Sweden pubmed.ncbi.nlm.nih.gov

Drug Survival and Long-term Outcome of Tofacitinib in Patients with Alopecia Areata: A Retrospective Study. [2023]

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

Immune-related alopecia (areata and universalis) in cancer patients receiving immune checkpoint inhibitors. [2018]

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

Safety of Janus Kinase inhibitors in Patients with Alopecia Areata: A Systematic Review. [2023]

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

Treatment of alopecia areata partim universalis with efalizumab. [2019]

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

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

13. Denmark pubmed.ncbi.nlm.nih.gov

Scalp biomarkers during dupilumab treatment support Th2 pathway pathogenicity in alopecia areata. [2023]