Alopecia Areata Clinical Trials

⁃ In order to be eligible to participate in this study, a subject must meet all of the following criteria, either at the screening and Day 1 visits or only at 1 of the specified visits (screening or Day 1) as noted in the criterion:

• Male or female subject aged 18 to 55 years, inclusive, at the time of informed consent.

• Subject has a body mass index (BMI) between 18.0-35.0 kg/m2, inclusive, at screening.

• Subject has a body weight ≥ 50 kg, inclusive, at screening.

• Subject has a clinically confirmed diagnosis of AA at screening visit, based on investigator's judgement.

• For the treatment area(s) receiving ALD-102 Solution: subject must have AA lesion(s) that can accommodate the required number of injections per cohort: 20 injections for Cohorts 1#-3# and 40 injections for Cohort 4#.

‣ A single scalp lesion of AA should preferably be selected as the treatment area to receive all injections.

• For Cohorts 1#-3#: a total of 20 injections requires a scalp treatment area of 12 cm2 (1.86 in2).

∙ For Cohort 4#: a total of 40 injections requires a scalp treatment area of 28 cm2 (4.34 in2).

⁃ If a single scalp lesion of AA cannot accommodate the full number of required injections per cohort, multiple scalp treatment areas may be selected:

‣ \- In such cases, each scalp treatment area must be large enough to accommodate at least 6 injections (2 cm2 \[0.31 in2\]).

⁃ All selected treatment area(s) must display a near-complete or complete absence of terminal hairs and should be clinically similar, as judged by the investigator.

• For the control area:

‣ Cohorts 1# and 2#: subjects must have a control AA scalp lesion selected measuring approximately 2 cm² (0.31 in2) to receive 6 placebo injections. This area should be located ≥ 6 cm from the designated treatment area(s), exhibit a near-complete or complete absence of terminal hairs, be clinically similar to the selected treatment area(s) as judged by the investigator, and preferably be positioned contralaterally to one of the selected treatment areas.

⁃ Cohorts 3# and 4#: subjects must have an untreated AA scalp lesion selected measuring at least 2 cm² (0.31 in2). This area should be located ≥ 6 cm from the designated treatment areas, exhibit a near-complete or complete absence of terminal hairs, be clinically similar to the selected treatment area(s) as judged by the investigator, and preferably be positioned contralaterally to one of the selected treatment areas.

• Duration of current episode of hair loss at the treatment and control areas \> 6 months but \< 5 years at screening and Day 1, along with investigators' assessment that hair regrowth is possible. Total duration of current episode of hair loss outside of treatment and control areas and total duration since diagnosis of AA could be \> 5 years.

• No evidence of active regrowth or hair loss present at baseline and no known history of significant regrowth or hair loss, as per investigator's judgement, over the last 6 months.

• Subject is willing to keep the same hairstyle and color (eg, hair products, process, and timing for hair appointments) for the duration of the trial.

• Note: Hair dying and shaving of scalp is allowed during the trial but not within 2 weeks prior to a study visit.

⁃ For female subject of childbearing potential involved in any sexual intercourse that could lead to pregnancy: the subject must agree to use a highly effective contraceptive method in addition to use of condom for their non-vasectomized male partner(s) from ≥ 4 weeks prior to Day 1 until ≥ 16 weeks after the last injection, and refrain from egg retrieval/egg donation during this period. Highly effective contraceptive methods include hormonal contraceptives (eg, combined oral contraceptive, patch, vaginal ring, injectable, or implant), intrauterine devices or intrauterine systems, vasectomized partner(s) (provided his vasectomy was performed ≥ 4 months prior to Screening), tubal ligation or double barrier methods of contraception (eg, male condom with cervical cap, male condom with diaphragm, and male condom with contraceptive sponge) in conjunction with spermicide.

⁃ Note: Subjects must have been on a stable dose of hormonal contraceptives for ≥ 4 weeks before Day 1.

⁃ Note: The above list of contraceptive methods does not apply to subjects who are abstinent for ≥ 4 weeks before Day 1 and will continue to be abstinent from penile-vaginal intercourse throughout the trial or for ≥ 16 weeks after the last injection. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not acceptable.

⁃ Note: A female subject of nonchildbearing potential is defined as follows:

‣ Female subject who has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)

‣ Female subject who has had a cessation of menses for ≥ 12 months prior to the screening visit without an alternative medical cause, and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (refer to laboratory reference ranges for confirmatory levels).

⁃ For male subject involved in any sexual intercourse that could lead to pregnancy, subject must agree to use a condom and their female partner must use one of the highly effective contraceptive methods listed in Inclusion Criterion #10, from Day 1 until ≥ 16 weeks after the last injection and refrain from donating sperm during this period. If the female partner of a male subject uses any of the hormonal contraceptive methods listed above, this contraceptive method should be used by the female partner from ≥ 4 weeks before Day 1 until ≥ 16 weeks after the last injection.

⁃ Female subject of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1.

⁃ Subject is willing to participate and is capable of giving a signed and dated informed consent.

⁃ Note: Consent must be obtained prior to any study-related procedures.

⁃ Subjects must be willing to comply with all study procedures and must be available for the duration of the study.

⁃ Subjects must be willing to receive approximately 20 to 40 intradermal injections every 4 weeks (number of injections will vary for each cohort).