ALD-102 for Alopecia Areata

Recruiting at 5 trial locations

Overseen By Chief Scientific Officer

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Aldena Therapeutics

Must not be taking: Steroids, JAK inhibitors

Disqualifiers: Severe AA, Other alopecia, Cancer, others

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ALD-102 for individuals with alopecia areata, a condition that causes patchy hair loss. The aim is to determine if ALD-102 is safe and effective in promoting hair regrowth when injected into the scalp. Participants will receive both the ALD-102 treatment and a placebo (a harmless saline solution) in different scalp areas to compare results. The trial seeks individuals who have had alopecia areata for more than 6 months but less than 5 years, with no significant recent hair regrowth. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial requires participants to stop certain medications before joining. Specifically, you must not have used systemic treatments for inflammatory conditions, certain topical treatments, or specific medications affecting hair regrowth within 4 weeks before starting the trial. Additionally, you should not have used systemic or intralesional steroids within 8 weeks before the trial.

Is there any evidence suggesting that ALD-102 Solution is likely to be safe for humans?

Research shows that ALD-102 Solution is in the early testing phase to determine its safety when injected into the scalp for treating alopecia areata. As this is the first human trial, solid information about its safety is limited. In this early stage, researchers are gathering basic data on possible side effects and how well participants tolerate the treatment.

While specific side effects for ALD-102 are not yet known, early trials are designed to monitor safety issues closely. Since the treatment is not approved for other uses, no existing safety data is available. Participants in these trials help researchers learn about the treatment's safety, paving the way for more advanced studies in the future. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alopecia areata?

Unlike the standard treatments for alopecia areata, which often include corticosteroids and immunotherapy, ALD-102 offers a novel approach by targeting specific pathways involved in hair follicle regeneration. Researchers are excited about ALD-102 because it introduces a new active ingredient that may stimulate hair growth more effectively. Moreover, this solution could potentially offer fewer side effects compared to current systemic treatments, making it a promising alternative for those seeking a safer option.

What evidence suggests that ALD-102 Solution might be an effective treatment for alopecia areata?

Research has shown that ALD-102 Solution is under investigation in this trial to determine its potential to regrow hair in individuals with alopecia areata, a condition that causes hair loss. Participants will receive either ALD-102 or a placebo. As this treatment remains in the early testing stages, limited information exists on its efficacy. The primary focus so far has been on its safety and tolerability. ALD-102 is designed for injection into the scalp to encourage hair growth. Early signs suggest promise, but further research is necessary to confirm its effectiveness. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-55 with a BMI of 18.0-35.0 kg/m2, weighing at least 50 kg, who have alopecia areata (AA) with hair loss lasting between 6 months and 5 years but not more than that overall. Participants must have two similar AA patches on the scalp suitable for injections and agree to maintain their hairstyle and color throughout the study. Women must use effective contraception.

Inclusion Criteria

My BMI is between 18.0 and 35.0.

I weigh at least 50 kg.

I haven't had significant hair loss or regrowth in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALD-102 Solution or placebo injections in the scalp every 4 weeks for a treatment period of 8 weeks

8 weeks

Injections every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of adverse effects and injection site reactions

16 weeks

Assessments every 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ALD-102 Solution

Trial Overview The trial tests ALD-102 Solution's safety and effectiveness in promoting hair regrowth compared to a placebo (saline solution). Subjects will receive injections in two areas of the scalp: one with ALD-102 and one with placebo every four weeks over an eight-week period.

How Is the Trial Designed?

Group I: ALD-102 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Aldena Therapeutics

Lead Sponsor

Trials

1

Recruited

20+

Citations

1. naaf.org naaf.org/studies/ald-102-solution-in-alopecia-areata/

A Clinical Study to Evaluate the Safety, Tolerability ... This first-in-human clinical trial aims to learn if ALD-102 Solution is safe and well tolerated following injections in the scalp in subjects with alopecia ...

2. trialx.com trialx.com/clinical-trials/listings/305969/a-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-ald-102-solution-in-subjects-with-alopecia-areata/

A Clinical Study to Evaluate the Safety, Tolerability ... 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 ...

3. withpower.com withpower.com/trial/phase-2-alopecia-1-2025-7e4bd?fbclid=IwZXh0bgNhZW0CMTEAAR4__VTils7EUN54bYa2VfDsM6MDSq983YiB2C3_NAVoEQTvr1NsTJHY8PbnAw_aem_YKyUrLOXwC6M9e0qjh443Q

ALD-102 for Alopecia Areata Trial Overview The trial tests ALD-102 Solution's safety and effectiveness in promoting hair regrowth compared to a placebo (saline solution). Subjects will ...

4. synapse.patsnap.com synapse.patsnap.com/drug/20d470b432cd4f76bd696c4713d8c6d8

ALD-102 - Drug Targets, Indications, Patents The primary efficacy end point was survival without any of six major functional disabilities at month 24. The secondary end points included overall survival at ...

5. researchtrials.org researchtrials.org/active_studies/alopecia-areata-study-6-months/

Alopecia Areata Study (6 Months) 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 ...