A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Alopecia Areata (AA)

In brief

The goal of this first-in-human clinical trial is to learn if ALD-102 Solution is safe and well tolerated following injections in the scalp in subjects with alopecia areata. The study will also learn about the effect of ALD-102 on hair regrowth in treatment areas. The researchers will compare the effects of ALD-102 Solution (drug) to placebo (saline solution that contains no drug) or an untreated area. Study participants will have treatment areas selected on the scalp to receive ALD-102 Solution (drug), placebo (saline solution) or to remain untreated. Injections will occur once every 4 weeks for a treatment period of 8 weeks.

Key facts

Study ID

NCT06826196

Run by

Aldena Therapeutics

People needed

24

Starts

2025-03-24

Expected to finish

2026-12-01

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• A subject who meets any of the following criteria at the screening and/or Day 1 visits, as applicable, will be excluded from participation in this study:
• Very severe AA, defined by SALT score ≥ 95 at screening and/or Day 1, including alopecia universalis and alopecia totalis.
• Presence of another form of alopecia (eg, androgenetic alopecia [AGA], traction and scarring alopecia, telogen effluvium).
• Note: Subjects with AGA are permitted only if the disorder is clinically distinct, physically separate, and does not affect or interfere with treatment or assessment of the selected treatment and control area(s) of AA. The diagnosis of AA should be clear and unambiguous, and the pattern and location of AGA should not overlap with or compromise the evaluation of the selected treatment and control areas of AA.
• Presence of diffuse type of AA. Note: Subjects with presence of ophiasis or siapho patterns of AA are allowed.
• History or presence of hair transplants.
• History or presence of micropigmentation of the scalp. Note: microblading of the eyebrows is permitted.
• Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
• Subject is known to have immune deficiency or is immunocompromised.
• Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded.
• Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
• Subject has any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with the interpretation of trial results.
• Subject has a positive result for hepatitis B virus (HBV; positive for hepatitis B surface antigens [HBsAg] or positive for hepatitis B antibodies to core antigens [anti-HBc]; subjects having a negative HBsAg and a positive anti-HBc may enroll if they have a positive hepatitis B surface antibody [anti-HBs] demonstrating natural immunity), hepatitis C virus (HCV; positive for HCV antibodies; however, a subject with documented proof of cure from HCV may be enrolled), or human immunodeficiency virus (HIV).
• Subject has a current or recent clinically serious viral, bacterial, fungal, or parasitic infection, including but not limited to the following:
• History of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 1;
• Have active chronic or acute skin infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to Day 1, or superficial skin infections within 1 week prior to Day 1;
• History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster;
• Known active tuberculosis (TB) or a positive TB infection test at screening. Subject will be evaluated for latent TB infection with a purified protein derivative (PPD) test or a QuantiFERONTB Gold test. Subjects who demonstrate evidence of latent TB infection (either PPD ≥ 5 mm of induration or positive QuantiFERON-TB Gold test, irrespective of Bacillus Calmette-Guérin vaccination status) will only be allowed to participate in the study if there is documented evidence of a completed adequate treatment course for latent TB (with negative chest x-ray findings for active TB).
• Note: A recent viral upper respiratory tract infection or uncomplicated urinary tract infection should not be considered clinically serious.
• At screening, any of the following (tests may be repeated once within the same screening period to confirm results prior to Day 1):
• Absolute neutrophil count < 1.5 x 109/L;
• Absolute lymphocyte count < 0.5 x 109/L;
• Hemoglobin < 11.0 g/dL or hematocrit < 30%;
• Platelet count < 100 x 109/L;
• Clinically significant abnormal estimated creatinine clearance as per investigator judgement (eg, < 90 mL/min based on the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) or serum creatinine value > 1.5 times the upper limit of normal (ULN);

Where it is running

• Clinical Trial Research Institute — Thousand Oaks, California, United States (enrolling)
• Options Research Group — West Lafayette, Indiana, United States (enrolling)
• The Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Dermatology Specialists of Spokane — Spokane, Washington, United States (enrolling)
• The Centre for Clinical Trials — Oakville, Ontario, Canada (enrolling)
• Innovaderm — Montreal, Quebec, Canada (enrolling)
• Centre de Recherche Saint-Louis — Québec, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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