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Alopecia Areata (AA)Phase 1/2ARISENCT06826196

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

A Phase 1/2 study testing ALD-102 Solution in people with Alopecia Areata (AA), run by Aldena Therapeutics at 8 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Alopecia Areata (AA)
What is being tested?
ALD-102 Solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9 participants
Where
8 sitesin 2 countries
Study dates
24 Mar 2025to Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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: 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).

Who cannot join

  • 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.
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  • 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);
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 x the ULN;
  • Total bilirubin ≥ 1.5 x ULN; subjects with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is ≤ ULN.
  • Subject has a history of clinically significant heart disease in the opinion of the investigator (eg, cardiomyopathy, major congenital heart disease, Wolff-Parkinson-White syndrome, heart attack, stroke, or blood clots).
  • Subject is currently receiving anti-coagulants or medications known to cause thrombocytopenia (unless considered safe by the investigator to stop and washout for the duration of the study).
  • Active forms of other inflammatory skin disease(s) or evidence of other skin conditions on the scalp (eg, psoriasis, seborrheic dermatitis, lupus) at screening and/or Day 1, that in the opinion of the investigator might interfere with evaluation of hair regrowth.
  • Subject has presence of any tattoos, scratches, open sores, or skin damages in the target treatment or control areas that, in the opinion of the investigator, may interfere with study evaluations.
  • Subject is currently treated or was treated within 4 weeks prior to Day 1 with any systemic treatment or oral medication for inflammatory condition that in the opinion of the investigator might interfere with the safety or efficacy assessments; short half-life medications like ibuprofen, paracetamol, and antihistamines are acceptable.
  • Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.
  • Subject has received a live or live-attenuated vaccine within 4 weeks prior to Day 1 or plans to receive a live or live-attenuated vaccine during the study and up to 4 weeks or 5 half-lives (of the study product), whichever is longer, after the last study product administration.
  • Use of systemic and/or intralesional steroids within 8 weeks of Day 1 visit. Note: Intranasal and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed.
  • Use of systemic treatments including, but not limited to, anthralin, squaric acid, diphenylcycloprophenone (DPCP), dinitrochlorobenzene (DCNB), tacrolimus, minoxidil, or any other medication which in the opinion of the investigator may affect hair regrowth within 4 weeks of Day 1 visit.
  • Subject 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.
  • Topical medicated treatment on the scalp that could affect AA including, but not limited to, topical corticosteroids, calcineurin inhibitors, minoxidil, JAK inhibitors, medical devices within 2 weeks prior to Day 1 visit.
  • Note: Topical medicated treatments are permitted outside of the scalp.
  • Subject has previously used a systemic JAK inhibitor for their AA (eg. baricitinib, ritlecitinib, deuruxolitinib) and discontinued for lack of efficacy (information obtained from medical chart or subject's physician, or directly from the subject).
  • Note: Subjects that used a systemic JAK inhibitor for AA and discontinued for another reason than lack of efficacy, or used a systemic JAK inhibitor for another reason than AA, are allowed but must have discontinued the systemic JAK inhibitor at least 6 months prior to Day 1.
  • Use of platelet-rich plasma injections in the last 12 weeks prior to Day 1.
  • Subject has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
  • Subject who has 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.
  • Subject who has received previous treatment with pDC inhibiting therapies (eg, anti immunoglobulin-like transcript [ILT]7, anti-blood dendritic cell antigen 2 [BDCA2]).
  • Subject has received any prescription products containing exogenous androgens, including but not limited to testosterone, or anabolic-androgenic steroids, within the past 6 months before Day 1.
  • Note: There is no washout period for over-the-counter (OTC), supplements, and/or herbal product that can contain exogenous androgens or can affect hair regrowth. However, if the subject is using any of these products for the purpose of AA, they must stop using the products at the time of informed consent and for the duration of the trial.
  • Subject has a known or suspected allergy to ALD-102 or any component of the investigational product.
  • Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
  • Subject has a history of an allergic reaction or significant sensitivity to lidocaine or other local anesthetics.
  • Subject has a history of hypertrophic scarring or keloid formation in scars or suture sites.
  • Subject has taken anticoagulant medication, such as heparin, low molecular weight (LMW)-heparin, warfarin, antiplatelets (except low-dose aspirin ≤ 81 mg which will be allowed), within 2 weeks prior to Day 1, or has a contraindication to skin biopsies. Short half-life nonsteroidal anti-inflammatory drugs (NSAIDs) will not be considered antiplatelets and will be allowed.
  • Subject is not able to tolerate intradermal injection or has a known sensitivity to needle injection.
  • Subject is institutionalized because of legal or regulatory order.

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

United States5 sites

  • The Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Lahey Clinic

    Burlington, Massachusetts, 01803

  • Dermatology Specialists of Spokane

    Spokane, Washington, 99202

  • Clinical Trial Research Institute

    Thousand Oaks, California, 91320

  • Options Research Group

    West Lafayette, Indiana, 47906

Other trials in United States

Canada3 sites

  • Innovaderm

    Montreal, Quebec, H2X 2V1

  • The Centre for Clinical Trials

    Oakville, Ontario, L6J 7W5

  • Centre de Recherche Saint-Louis

    Québec, Quebec, QC G1W 4R4

Other trials in Canada

About this study

Official title: A Phase 1B/2A, Intraindividual Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution for Intradermal Injection in Subjects With Alopecia Areata

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.

Being tested
ALD-102 Solution, Placebo or Control
Medical subject headings
Alopecia Areata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALD-102 SolutionDrug

    Treatment every 4 weeks for total of 8-week treatment period.

  • Placebo or ControlOther

    Treatment every 4 weeks for 8-week treatment period

Study groups in NCT06826196
Study groupRoleWhat they receive
Control: Placebo or Untreated AreaOtherNot described
Receives: Other: Placebo or Control
ALD-102 SolutionExperimentalNot described
Receives: Drug: ALD-102 Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse effects (AEs) and severe adverse effects (SAEs) as assessed by CTCAE, and injection site reactions (ISRs), evaluated by local tolerability assessments and numerical scales.

    AEs assessed by guidelines outlined in CTCAE at baseline, during treatment and follow-up periods. ISRs assessed by local tolerability assessments (LTA), including evaluation by the investigator of erythema, swelling, induration, and bruising, and evaluation by the subject of burning, stinging and itching. Grading using a 4-point scale of 0 to 3 (non, mild, moderate, severe) will be used to assess each sign. Pain at each treatment area will also be assessed using a pain numerical rating scale (NRS). Subjects will be asked to assign a numerical score representing the average pain intensity on a scale of 0 to 10, experienced during and after product administration. The LTA will be done during injection days and during the follow up period.

    Measured: Clinical assessments during treatment and follow up period for a total of 24 weeks.

Secondary outcomes (1)

  1. Concentration of ALD-102 in skin biopsies at Week 10 and plasma concentration of ALD-102 over time.

    Skin biopsies will be collected to measure drug concentration in skin.

    Blood samples will be collected to measure the systemic exposure of ALD-102 in plasma.

    Measured: Skin biopsies will be collected at Week 10 and/or baseline. Blood samples will be collected on Day 1 before and after product administration, on Day 2, Week 8 and Week 16.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2025
  2. Study start24 Mar 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06826196
Sponsor's protocol ID
ALD-102Sol-001
Acronym
ARISE
Status last verified
Nov 2026
First submitted
22 Jan 2025
Last updated
4 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ALD-102 Solution in people with Alopecia Areata (AA), run by Aldena Therapeutics at 8 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 24 inclusion and 54 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

This study is still under way. Results are not available in the source record yet.

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?

Number of participants with treatment-related adverse effects (AEs) and severe adverse effects (SAEs) as assessed by CTCAE, and injection site reactions (ISRs), evaluated by local tolerability assessments and numerical scales. (time frame: Clinical assessments during treatment and follow up period for a total of 24 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06826196.

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 4 Nov 2026.

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