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

NCT06826196 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ALD-102Sol-001
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 7

Brief 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. 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.

Conditions

Alopecia Areata (AA)

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

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

  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.

Study Arms (2)

Control: Placebo or Untreated Area

OTHER

Other: Placebo or Control

ALD-102 Solution

EXPERIMENTAL

Drug: ALD-102 Solution

Interventions

ALD-102 Solution DRUG

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

ALD-102 Solution

Placebo or Control OTHER

Treatment every 4 weeks for 8-week treatment period

Control: Placebo or Untreated Area

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

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;

Sponsors & Collaborators

• Aldena Therapeutics: lead

Study Sites (7)

Clinical Trial Research Institute

Thousand Oaks, California, 91320, United States

RECRUITING

Options Research Group

West Lafayette, Indiana, 47906, United States

RECRUITING

The Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

RECRUITING

The Centre for Clinical Trials

Oakville, Ontario, L6J 7W5, Canada

RECRUITING

Innovaderm

Montreal, Quebec, H2X 2V1, Canada

RECRUITING

Centre de Recherche Saint-Louis

Québec, Quebec, QC G1W 4R4, Canada

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Chief Scientific Officer

CONTACT

+44 2045915017; info@aldenatherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Masking information above represents cohort 1 only.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 13, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); CA (3)