Adults 18 to 65, any sex, with Alopecia Areata. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Change From Baseline in SALT Score at Week 24Primary· 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
Group
Value
95% CI
Daxdilimab 300 mg
-12.6
± 35.15
Percent Change From Baseline in SALT Score at Weeks 12, 16, 20, 28, 32, and 36Secondary· Baseline to 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
Week 12
Group
Value
95% CI
Daxdilimab 300 mg
-5.4
± 21.57
Week 16
Group
Value
95% CI
Daxdilimab 300 mg
-8.1
± 26.58
Week 20
Group
Value
95% CI
Daxdilimab 300 mg
-10.0
± 30.10
Week 28
Group
Value
95% CI
Daxdilimab 300 mg
-16.2
± 34.35
Week 32
Group
Value
95% CI
Daxdilimab 300 mg
-17.2
± 37.16
Week 36
Group
Value
95% CI
Daxdilimab 300 mg
-18.2
± 37.22
Percentage of Participants Who Achieved a ≥ 50% Reduction in SALT Score From Baseline at Weeks 12, 16, 20, 24, 28, 32, and 36Secondary· Baseline to 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
Week 12
Group
Value
95% CI
Daxdilimab 300 mg
3.3
0.1 – 17.2
Week 16
Group
Value
95% CI
Daxdilimab 300 mg
10.0
2.1 – 26.5
Week 20
Group
Value
95% CI
Daxdilimab 300 mg
13.3
3.8 – 30.7
Week 24
Group
Value
95% CI
Daxdilimab 300 mg
20.0
7.7 – 38.6
Week 28
Group
Value
95% CI
Daxdilimab 300 mg
20.0
7.7 – 38.6
Week 32
Group
Value
95% CI
Daxdilimab 300 mg
20.0
7.7 – 38.6
Week 36
Group
Value
95% CI
Daxdilimab 300 mg
20.0
7.7 – 38.6
Percentage of Participants Who Had an Absolute SALT Score ≤ 10 at Weeks 12, 16, 20, 24, 28, 32, and 36Secondary· 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.
Week 12
Group
Value
95% CI
Daxdilimab 300 mg
0.0
0.0 – 11.6
Week 16
Group
Value
95% CI
Daxdilimab 300 mg
0.0
0.0 – 11.6
Week 20
Group
Value
95% CI
Daxdilimab 300 mg
0.0
0.0 – 11.6
Week 24
Group
Value
95% CI
Daxdilimab 300 mg
3.3
0.1 – 17.2
Week 28
Group
Value
95% CI
Daxdilimab 300 mg
6.7
0.8 – 22.1
Week 32
Group
Value
95% CI
Daxdilimab 300 mg
10.0
2.1 – 26.5
Week 36
Group
Value
95% CI
Daxdilimab 300 mg
13.3
3.8 – 30.7
Percentage of Participants Who Had an Absolute SALT Score ≤ 20 at Weeks 12, 16, 20, 24, 28, 32, and 36Secondary· 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.
Week 12
Group
Value
95% CI
Daxdilimab 300 mg
0.0
0.0 – 11.6
Week 16
Group
Value
95% CI
Daxdilimab 300 mg
0.0
0.0 – 11.6
Week 20
Group
Value
95% CI
Daxdilimab 300 mg
6.7
0.8 – 22.1
Week 24
Group
Value
95% CI
Daxdilimab 300 mg
13.3
3.8 – 30.7
Week 28
Group
Value
95% CI
Daxdilimab 300 mg
16.7
5.6 – 34.7
Week 32
Group
Value
95% CI
Daxdilimab 300 mg
16.7
5.6 – 34.7
Week 36
Group
Value
95% CI
Daxdilimab 300 mg
16.7
5.6 – 34.7
Percentage of Participants Who Had an Absolute SALT Score ≤ 30 at Weeks 12, 16, 20, 24, 28, 32, and 36Secondary· 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.
Week 12
Group
Value
95% CI
Daxdilimab 300 mg
6.7
0.8 – 22.1
Week 16
Group
Value
95% CI
Daxdilimab 300 mg
10.0
2.1 – 26.5
Week 20
Group
Value
95% CI
Daxdilimab 300 mg
10.0
2.1 – 26.5
Week 24
Group
Value
95% CI
Daxdilimab 300 mg
16.7
5.6 – 34.7
Week 28
Group
Value
95% CI
Daxdilimab 300 mg
16.7
5.6 – 34.7
Week 32
Group
Value
95% CI
Daxdilimab 300 mg
16.7
5.6 – 34.7
Week 36
Group
Value
95% CI
Daxdilimab 300 mg
20.0
7.7 – 38.6
Percentage of Participants Who Had an Absolute SALT Score ≤ 50 at Weeks 12, 16, 20, 24, 28, 32, and 36Secondary· 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.
Week 12
Group
Value
95% CI
Daxdilimab 300 mg
16.7
5.6 – 34.7
Week 16
Group
Value
95% CI
Daxdilimab 300 mg
23.3
9.9 – 42.3
Week 20
Group
Value
95% CI
Daxdilimab 300 mg
26.7
12.3 – 45.9
Week 24
Group
Value
95% CI
Daxdilimab 300 mg
26.7
12.3 – 45.9
Week 28
Group
Value
95% CI
Daxdilimab 300 mg
30.0
14.7 – 49.4
Week 32
Group
Value
95% CI
Daxdilimab 300 mg
30.0
14.7 – 49.4
Week 36
Group
Value
95% CI
Daxdilimab 300 mg
30.0
14.7 – 49.4
Percent Change From Baseline in SALT Score at Weeks 40, 44, and 48Secondary· Baseline to 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
Week 40
Group
Value
95% CI
Daxdilimab 300 mg
-19.4
± 37.72
Week 44
Group
Value
95% CI
Daxdilimab 300 mg
-20.6
± 40.67
Week 48
Group
Value
95% CI
Daxdilimab 300 mg
-22.1
± 41.43
Percentage of Participants Who Achieved a ≥ 50% Reduction in SALT Score From Baseline at Weeks 40, 44, and 48Secondary· Baseline to 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
Week 40
Group
Value
95% CI
Daxdilimab 300 mg
20.0
7.7 – 38.6
Week 44
Group
Value
95% CI
Daxdilimab 300 mg
26.7
12.3 – 45.9
Week 48
Group
Value
95% CI
Daxdilimab 300 mg
23.3
9.9 – 42.3
Percentage of Participants Who Had an Absolute SALT Score ≤ 10 at Weeks 40, 44 and 48Secondary· 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.
Week 40
Group
Value
95% CI
Daxdilimab 300 mg
10.0
2.1 – 26.5
Week 44
Group
Value
95% CI
Daxdilimab 300 mg
10.0
2.1 – 26.5
Week 48
Group
Value
95% CI
Daxdilimab 300 mg
13.3
3.8 – 30.7
Percentage of Participants Who Had an Absolute SALT Score ≤ 20 at Weeks 40, 44 and 48Secondary· 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.
Week 40
Group
Value
95% CI
Daxdilimab 300 mg
16.7
5.6 – 34.7
Week 44
Group
Value
95% CI
Daxdilimab 300 mg
16.7
5.6 – 34.7
Week 48
Group
Value
95% CI
Daxdilimab 300 mg
16.7
5.6 – 34.7
Percentage of Participants Who Had an Absolute SALT Score ≤ 30 at Weeks 40, 44 and 48Secondary· 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.
Week 40
Group
Value
95% CI
Daxdilimab 300 mg
20.0
7.7 – 38.6
Week 44
Group
Value
95% CI
Daxdilimab 300 mg
20.0
7.7 – 38.6
Week 48
Group
Value
95% CI
Daxdilimab 300 mg
16.7
5.6 – 34.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 1 to Week 48.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05669014 — A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis
· Phase 2
· completed
NCT05540665 — Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN)
· Phase 2
· terminated
NCT05591222 — Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus
· Phase 2
· terminated
NCT05430854 — Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study
· Phase 2
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 7 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05368103.