Alopecia AreataPhase 2NCT05368103
Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata
A Phase 2 study testing Daxdilimab in people with Alopecia Areata, run by Amgen at 13 sites in 2 countries.
Trial summary
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, with ≥50% and ≤95% total scalp hair loss as defined by the SALT score at Screening and Day 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Daxdilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 27 Apr 2022to 26 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to give informed consent.
- Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
- Adult men or women 18 to 65 years of age.
- Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the trial.
- Clinical diagnosis of moderate-to-severe AA - defined as meeting the following criteria:
- Presence of ≥ 50% and ≤ 95% total scalp hair loss at screening and baseline (Day 1) defined by the SALT score.
- Duration of current episode of hair loss >3 months but <7 years at screening and Day 1, along with investigators' assessment that hair regrowth is possible.
- No evidence of active regrowth present at baseline and no known history of significant regrowth, as per investigator's judgement, over the last 6 months.
Who cannot join
- Individuals involved in the conduct of the trial, their employees, or immediate family members of such individuals.
- Any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with the evaluation of the IP or interpretation of trial results.
- History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or to a previous monoclonal antibody (mAb) or human immunoglobulin (Ig) therapy.
- Participant has had excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths within 4 weeks prior to Day 1 or is not willing to minimize natural and artificial sunlight exposure during the trial. Use of sunscreen products and protective apparel are recommended when sun exposure cannot be avoided.
- Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, a positive result for HIV infection, splenectomy, or any underlying condition that in the opinion of the investigator significantly predisposes the participant to infection.
- Confirmed positive test for hepatitis B serology defined as:
Show all 37Show fewer
- Hepatitis B surface antigen (HBsAg), or
- Hepatitis B core antibody (HBcAb or anti-HBc)
- Positive test for hepatitis C virus antibody.
- Active tuberculosis (TB), or a positive TB test at Screening. Participant will be evaluated for latent TB infection with a purified protein derivative (PPD) test or a QuantiFERON-TB Gold test. Participants who demonstrate evidence of latent TB infection (either PPD ≥5 mm of induration or positive QuantiFERON-TB Gold test, irrespective of bacille Calmette-Guérin vaccination status will not be allowed to participate in the trial, unless documented history of appropriate treatment for active or latent TB. Participants with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded.
- Any severe herpes virus family infection (including Epstein-Barr virus, cytomegalovirus [CMV]) at any time prior to Day 1, including, but not limited to, disseminated herpes, herpes encephalitis, recent recurrent herpes zoster (defined as 2 episodes within the last 2 years), or ophthalmic herpes.
- Any herpes zoster, CMV, or Epstein-Barr virus infection that was not completely resolved 12 weeks prior to Day 1.
- Any of the following within 30 days prior to signing the ICF and though Day 1:
- Clinically significant active infection in the opinion of the investigator, including ongoing, and chronic infection requiring antibiotics or antiviral medication (chronic nail infections are allowed). Note: Participant with a limited recurrence of a cold sore or herpes genitalis between ICF signature and Day 1 could be eligible based on the investigator's judgement.
- Any infection requiring hospitalization or treatment with intravenous (IV) anti-infectives.
- A participant with a documented positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test may be rescreened at least 2 weeks after a positive test if the participant is asymptomatic and at least 3 weeks after resolution of symptomatic Coronavirus Disease 2019 (COVID-19) illness.
- Opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within 2 years prior to Day 1.
- Any acute illness or evidence of clinically significant active infection, such as fever ≥ 38.0°C (≥ 100.5°F) on Day 1.
- History of clinically significant cardiac disease including unstable angina; myocardial infarction within 6 months prior to Day 1; congestive heart failure; arrhythmia requiring active therapy, except for clinically insignificant extra systoles, or minor conduction abnormalities; or presence of clinically significant abnormality on ECG if, in the opinion of the investigator, it would increase the risk of trial participation.
- History of cancer or lymphoproliferative disease within 5 years prior to Day 1, except as follows:
- In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to Screening, or
- Nonmetastatic cutaneous basal cell or squamous cell carcinoma of the skin treated with apparent success with curative therapy.
- Active forms of other inflammatory skin disease(s) or evidence of other skin conditions (eg, psoriasis, seborrheic dermatitis, lupus) at the time of the Screening and through Day 1, that in the opinion of the investigator might interfere with evaluation of AA and the assessment of the activity measures.
- Presence of another form of alopecia (except for androgenic alopecia).
- History of male or female pattern hair loss > Hamilton stage III or > Ludwig stage II.
- History or presence of hair transplants.
- History or presence of micropigmentation of the scalp (Note: microblading of the eyebrows is permitted).
- Use of steroids (systemic and intralesional), anthralin, squaric acid, diphenylcycloprophenone (DPCP), dinitrochlorobenzene (DCNB), protopic, minoxidil, or any other medication which in the opinion of the investigator may affect hair regrowth within 4 weeks of Day 1 visit. Note: Intranasal and inhaled corticosteroids are allowed, eye and ear drops containing corticosteroids are also allowed.
- Use of platelet-rich plasma injections in the last 12 weeks prior to Day 1.
- Topical medicated treatment that could affect AA including, but not limited to, topical corticosteroids, calcineurin inhibitors, antimicrobials, medical devices within 2 weeks of Day 1 visit. Note: Topical corticosteroids are permitted outside of the scalp, eyebrows, and eyelids.
- Participants who have had previous treatment with any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, or ofatumumab) or other B-cell targeting therapy (eg, belimumab) within 12 months before Day 1.
- Participants who have received previous treatment with pDC inhibiting therapies (eg, anti-ILT7, anti-blood dendritic cell antigen 2 [BDCA2]).
- Inadequate response to adequate trial of oral Janus Kinase (JAK) inhibitors. Previous exposure to topical JAK inhibitors is acceptable, regardless of response.
- Any biologic or conventional disease-modifying antirheumatic drugs (DMARD), immunosuppressant (eg, cyclosporine, methotrexate, or azathioprine), JAK-inhibitors, interferon (IFN) blocking therapies, or antiproliferative agents, if last dose was taken: a. within 8 weeks prior to Day 1 or b. drug-specific 5 half-lives elimination period (if longer than 8 weeks).
- Participant has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
- Currently receiving a nonbiological IP or device or has received one within 4 weeks prior to Day 1 or within 5 published half-lives, whichever is longer.
- Participant has received any ultraviolet (UV)-B phototherapy (including tanning beds), has had psoralen-UV-A (PUVA) treatment, or excimer laser within 4 weeks prior to Day 1.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Canada7 sites
Dr Dusan Sajic Medicine Professional Corporation
Guelph, Ontario, N1L 0B7
Lynderm Research Inc.
Markham, Ontario, L3P 1X3
Innovaderm Research
Montreal, Quebec, H2X 2V1
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2,
Centre de Recherche Saint-Louis (Quebec)
Québec, G1W 4R4
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
United States6 sites
First OC Dermatology Research, Inc.
Fountain Valley, California, 92708
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
DS Research
Louisville, Kentucky, 40241
Progressive Clinical Research, P.A.
San Antonio, Texas, 78213
Dermatology Specialists of Spokane
Spokane, Washington, 99202
ForCare Clinical Research
Tampa, Florida, 33613
About this study
Official title: A Phase 2A, Open Label, Proof of Concept Trial of Daxdilimab for the Treatment of Moderate To Severe Alopecia Areata
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, with ≥50% and ≤95% total scalp hair loss as defined by the SALT score at Screening and Day 1.
Read the detailed description
Approximately 30 participants will be enrolled to receive daxdilimab administered subcutaneously over 32 weeks. The maximum trial duration per participant is approximately 52 weeks, including up to 30 days for the screening period, 32 weeks for the open-label treatment period where participants will receive daxdilimab and approximately 16 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.
Study acquired from Horizon in 2024.
- Conditions
- Alopecia Areata
- Being tested
- Daxdilimab
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaxdilimabBiological
Also called HZN-7734
Daxdilimab will be administered subcutaneously as two injections for each dose.
| Study group | Role | What they receive |
|---|---|---|
| Daxdilimab | Experimental | Nine sets of Daxdilimab injections over a total of 32 weeks. Receives: Biological: Daxdilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in SALT Score at Week 24
The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms. A decrease in SALT score from baseline indicated a reduction in AA symptoms.
Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.
Measured: Baseline to Week 24
Secondary outcomes (17)
Percent Change From Baseline in SALT Score at Weeks 12, 16, 20, 28, 32, and 36
The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms. A decrease in SALT score from baseline indicated a reduction in AA symptoms.
Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.
Measured: Baseline to Weeks 12, 16, 20, 28, 32, and 36
Percentage of Participants Who Achieved a ≥ 50% Reduction in SALT Score From Baseline at Weeks 12, 16, 20, 24, 28, 32, and 36
The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms. A decrease in SALT score from baseline indicated a reduction in AA symptoms.
Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.
Measured: Baseline to Weeks 12, 16, 20, 24, 28, 32, and 36
Percentage of Participants Who Had an Absolute SALT Score ≤ 10 at Weeks 12, 16, 20, 24, 28, 32, and 36
The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms.
Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.
Measured: Weeks 12, 16, 20, 24, 28, 32, and 36
Percentage of Participants Who Had an Absolute SALT Score ≤ 20 at Weeks 12, 16, 20, 24, 28, 32, and 36
The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms.
Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.
Measured: Weeks 12, 16, 20, 24, 28, 32, and 36
Percentage of Participants Who Had an Absolute SALT Score ≤ 30 at Weeks 12, 16, 20, 24, 28, 32, and 36
The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms.
Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.
Measured: Weeks 12, 16, 20, 24, 28, 32, and 36
Percentage of Participants Who Had an Absolute SALT Score ≤ 50 at Weeks 12, 16, 20, 24, 28, 32, and 36
The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms.
Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.
Measured: Weeks 12, 16, 20, 24, 28, 32, and 36
Percent Change From Baseline in SALT Score at Weeks 40, 44, and 48
The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms. A decrease in SALT score from baseline indicated a reduction in AA symptoms.
Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.
Measured: Baseline to Weeks 40, 44, and 48
Percentage of Participants Who Achieved a ≥ 50% Reduction in SALT Score From Baseline at Weeks 40, 44, and 48
The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms. A decrease in SALT score from baseline indicated a reduction in AA symptoms.
Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.
Measured: Baseline to Weeks 40, 44, and 48
Percentage of Participants Who Had an Absolute SALT Score ≤ 10 at Weeks 40, 44 and 48
The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms.
Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.
Measured: Weeks 40, 44 and 48
Percentage of Participants Who Had an Absolute SALT Score ≤ 20 at Weeks 40, 44 and 48
The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms.
Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.
Measured: Weeks 40, 44 and 48
Percentage of Participants Who Had an Absolute SALT Score ≤ 30 at Weeks 40, 44 and 48
The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms.
Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.
Measured: Weeks 40, 44 and 48
Percentage of Participants Who Had an Absolute SALT Score ≤ 50 at Weeks 40, 44 and 48
The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms.
Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.
Measured: Weeks 40, 44 and 48
Serum Concentration of Daxdilimab
Blood samples were collected at the visits and time points specified.
All post-baseline concentrations below the limit of quantification (BLQ) were imputed as half of the lower limit of quantification value.
Measured: Baseline: 2 hours post-dose; Weeks 4-32: Pre-dose; Weeks 36-48: Any time during the visit.
Percent Change From Baseline in Plasmacytoid Dendritic Cell (pDC) Levels
Blood samples were collected at the visits and timepoints specified and analyzed using flow cytometry.
Measured: Baseline to Weeks 4, 12, 24, 32, 36 and 48
Number of Participants Who Experienced an Anti-drug Antibody (ADA) Response
The number of participants who experienced an ADA response was defined as participants with ADA positive post-baseline only or boosted their preexisting ADA during the study.
Measured: Baseline and Weeks 4, 8, 12, 24, and 36: Pre-dose
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
A TEAE was any untoward medical occurrence in a participant that was not present prior to treatment but appeared following treatment, was present at treatment initiation but worsened during treatment, or was present at the treatment initiation but resolved and then reappeared while the participant was on treatment and did not necessarily have a causal relationship with the treatment.
A serious TEAE was defined as any medical occurrence that had any of the following consequences:
- Resulted in death.
- Was life-threatening.
- Required in-patient hospitalization or prolongation of existing hospitalization.
- Resulted in persistent or significant disability/incapacity.
- Was a congenital anomaly/birth defect.
Measured: Day 1 to Week 48
Number of Participants Who Experienced an Adverse Event of Special Interest (AESI)
An AESI was defined as a serious or non-serious adverse event of scientific and medical interest specific to understanding the treatment and may have required close monitoring and collection of additional information by the investigator.
The following were defined as AESIs:
- Hypersensitivity reaction, including anaphylaxis.
- Severe viral infection/reactivation.
- Opportunistic infection.
- Malignancy (except non-melanoma skin cancer).
Measured: Day 1 to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start27 Apr 2022
- Primary completion7 Aug 2023
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368103
- Sponsor's protocol ID
- HZNP-DAX-201
- Status last verified
- Dec 2024
- First submitted
- 11 Apr 2022
- Last updated
- 7 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A, Open Label, Proof of Concept Trial of Daxdilimab for the Treatment of Moderate To Severe Alopecia Areata
- ClinicalTrials.gov ID
- NCT05368103
- Acronym / sponsor ID
- HZNP-DAX-201
- Conditions
- Alopecia Areata
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Posted 7 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, with ≥50% and ≤95% total scalp hair loss as defined by the SALT score at Screening and Day 1.
Detailed description
Approximately 30 participants will be enrolled to receive daxdilimab administered subcutaneously over 32 weeks. The maximum trial duration per participant is approximately 52 weeks, including up to 30 days for the screening period, 32 weeks for the open-label treatment period where participants will receive daxdilimab and approximately 16 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.
Study acquired from Horizon in 2024.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daxdilimab | Experimental | Biological: DaxdilimabNine sets of Daxdilimab injections over a total of 32 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to give informed consent.
- Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
- Adult men or women 18 to 65 years of age.
- Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the trial.
- Clinical diagnosis of moderate-to-severe AA - defined as meeting the following criteria:
Key exclusion criteria (37 listed)
- Individuals involved in the conduct of the trial, their employees, or immediate family members of such individuals.
- Any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with the evaluation of the IP or interpretation of trial results.
- History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or to a previous monoclonal antibody (mAb) or human immunoglobulin (Ig) therapy.
- Participant has had excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths within 4 weeks prior to Day 1 or is not willing to minimize natural and artificial sunlight exposure during the trial. Use of sunscreen products and protective apparel are recommended when sun exposure cannot be avoided.
- Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, a positive result for HIV infection, splenectomy, or any underlying condition that in the opinion of the investigator significantly predisposes the participant to infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaxdilimabAlso: HZN-7734Daxdilimab will be administered subcutaneously as two injections for each dose. | Biological | Daxdilimab |
Primary outcome
Percent Change From Baseline in SALT Score at Week 24
Time frame: Baseline to Week 24
The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms. A decrease in SALT score from baseline indicated a reduction in AA symptoms. Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.
17 secondary outcomes
Percent Change From Baseline in SALT Score at Weeks 12, 16, 20, 28, 32, and 36
Time frame: Baseline to Weeks 12, 16, 20, 28, 32, and 36
Percentage of Participants Who Achieved a ≥ 50% Reduction in SALT Score From Baseline at Weeks 12, 16, 20, 24, 28, 32, and 36
Time frame: Baseline to Weeks 12, 16, 20, 24, 28, 32, and 36
Percentage of Participants Who Had an Absolute SALT Score ≤ 10 at Weeks 12, 16, 20, 24, 28, 32, and 36
Time frame: Weeks 12, 16, 20, 24, 28, 32, and 36
Percentage of Participants Who Had an Absolute SALT Score ≤ 20 at Weeks 12, 16, 20, 24, 28, 32, and 36
Time frame: Weeks 12, 16, 20, 24, 28, 32, and 36
Percentage of Participants Who Had an Absolute SALT Score ≤ 30 at Weeks 12, 16, 20, 24, 28, 32, and 36
Time frame: Weeks 12, 16, 20, 24, 28, 32, and 36
Percentage of Participants Who Had an Absolute SALT Score ≤ 50 at Weeks 12, 16, 20, 24, 28, 32, and 36
Time frame: Weeks 12, 16, 20, 24, 28, 32, and 36
Percent Change From Baseline in SALT Score at Weeks 40, 44, and 48
Time frame: Baseline to Weeks 40, 44, and 48
Percentage of Participants Who Achieved a ≥ 50% Reduction in SALT Score From Baseline at Weeks 40, 44, and 48
Time frame: Baseline to Weeks 40, 44, and 48
Percentage of Participants Who Had an Absolute SALT Score ≤ 10 at Weeks 40, 44 and 48
Time frame: Weeks 40, 44 and 48
Percentage of Participants Who Had an Absolute SALT Score ≤ 20 at Weeks 40, 44 and 48
Time frame: Weeks 40, 44 and 48
Percentage of Participants Who Had an Absolute SALT Score ≤ 30 at Weeks 40, 44 and 48
Time frame: Weeks 40, 44 and 48
Percentage of Participants Who Had an Absolute SALT Score ≤ 50 at Weeks 40, 44 and 48
Time frame: Weeks 40, 44 and 48
Serum Concentration of Daxdilimab
Time frame: Baseline: 2 hours post-dose; Weeks 4-32: Pre-dose; Weeks 36-48: Any time during the visit.
Percent Change From Baseline in Plasmacytoid Dendritic Cell (pDC) Levels
Time frame: Baseline to Weeks 4, 12, 24, 32, 36 and 48
Number of Participants Who Experienced an Anti-drug Antibody (ADA) Response
Time frame: Baseline and Weeks 4, 8, 12, 24, and 36: Pre-dose
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 to Week 48
Number of Participants Who Experienced an Adverse Event of Special Interest (AESI)
Time frame: Day 1 to Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daxdilimab in people with Alopecia Areata, run by Amgen at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in SALT Score at Week 24 (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.