Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata

ABSTRACT

ConditionAlopecia Areata

InterventionBiological Daxdilimab

Primary outcome:Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 24.

Criteria
Inclusion Criteria

1. Willing and able to give informed consent.

2. Willing and able to comply with the prescribed treatment protocol and evaluations for
the duration of the trial.

3. Adult men or women 18 to 65 years of age.

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

5. 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.

Exclusion Criteria

1. Individuals involved in the conduct of the trial, their employees, or immediate family
members of such individuals.

2. 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.

3. 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.

4. 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.

5. 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.

6. Confirmed positive test for hepatitis B serology defined as

- Hepatitis B surface antigen (HBsAg), or

- Hepatitis B core antibody (HBcAb or anti-HBc)

7. Positive test for hepatitis C virus antibody.

8. 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.

9. 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.

10. Any herpes zoster, CMV, or Epstein-Barr virus infection that was not completely
resolved 12 weeks prior to Day 1.

11. 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.

12. Opportunistic infection requiring hospitalization or parenteral antimicrobial
treatment within 2 years prior to Day 1.

13. Any acute illness or evidence of clinically significant active infection, such as
fever = 38.0°C (= 100.5°F) on Day 1.

14. 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.

15. 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.

16. 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.

17. Presence of another form of alopecia (except for androgenic alopecia).

18. History of male or female pattern hair loss > Hamilton stage III or > Ludwig stage II.

19. History or presence of hair transplants.

20. History or presence of micropigmentation of the scalp (Note microblading of the
eyebrows is permitted).

21. 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 corticoster