Recruiting PHASE1, PHASE2 Alopecia Areata (AA)

Tests treatment safety and results for Alopecia Areata (AA)

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

ClinicalTrials.gov ID: NCT06826196

What this study is testing

What is ALD-102 Solution?

ALD-102 Solution is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for alopecia areata (aa).

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: 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.

Phase 2: a mid-size study of how well it works
Time commitment: about 8 weeks
You might receive a placebo (an inactive treatment) instead of the study drug.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 55

You may be able to join 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...
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.

You likely can't join 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...
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: people with AGA are...
Presence of diffuse type of AA. Note: people 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.

See the full eligibility criteria

Who can 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...
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...
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#: people 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)...
Cohorts 3# and 4#: people 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...
Duration of current episode of hair loss at the treatment and control areas \> 6 months but \ 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...
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...
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...
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...
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.
people must be willing to comply with all study procedures and must be available for the duration of the study.
people must be willing to receive approximately 20 to 40 intradermal injections every 4 weeks (number of injections will vary for each cohort).

What rules you out

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: people with AGA are permitted only if the disorder is clinically distinct, physically...
Presence of diffuse type of AA. Note: people 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. people with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in...
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...
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]; people having a negative HBsAg and a...
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...
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. people who...
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, \ 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; people 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...
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...
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)...
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...
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...
Subject has previously used a systemic JAK inhibitor for their AA (eg. baricitinib, ritlecitinib, deuruxolitinib) and discontinued for lack of how well it works (information obtained from medical chart or subject's...
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...
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...
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.

The study team makes the final eligibility decision.

Where it's taking place

Thousand Oaks, California, United States
West Lafayette, Indiana, United States
Boston, Massachusetts, United States
Spokane, Washington, United States
Oakville, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Thousand Oaks, California, United States; West Lafayette, Indiana, United States; Boston, Massachusetts, United States; Spokane, Washington, United States; Oakville, Ontario, Canada; Montreal, Quebec, Canada and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.