BridgeMD
New treatment option for Alopecia Areata
Official title A Study of LAD603 in Adults With Alopecia Areata
ClinicalTrials.gov ID: NCT07311564
What this study is testing
What is LAD603?
LAD603 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for alopecia areata.
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 main aim of the study is to evaluate the effect of LAD603 in adult participants with severe to very severe alopecia areata (AA). The study will also evaluate the safety, pharmacokinetics (PK), immunogenicity and pharmacodynamic (PD) biomarkers of LAD603.
- Phase 2: a mid-size study of how well it works
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 65
You may be able to join if
- Participant is a male or female between 18 and 65 years old at the time of signing the informed consent.
- Severe to very severe AA criteria:
- Greater than or equal to (\>=) 50% hair loss of the scalp as measured by SALT without evidence of terminal hair regrowth within 6 months at both the...
- Current episode of hair loss lasting at least 6 months and not exceeding 7 years.
- Participants who are WOCBP or male must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD603...
You likely can't join if
- AA, Skin Specific, and Other Inflammatory Diseases
- Participants have other types of alopecia (including but not limited to traction, scarring alopecia).
- Participants with "diffuse" type AA.
- Currently has an active form of other inflammatory skin disease(s) or evidence of skin condition (e.g., psoriasis, seborrheic dermatitis, lupus) at...
- Participant has previous severe adverse reaction to subcutaneously administered medication.
- Participant has any of the following liver safety laboratory results at Screening
See the full eligibility criteria
- Participant is a male or female between 18 and 65 years old at the time of signing the informed consent.
- Severe to very severe AA criteria:
- Greater than or equal to (\>=) 50% hair loss of the scalp as measured by SALT without evidence of terminal hair regrowth within 6 months at both the Screening and Baseline (Day 1) visits.
- Current episode of hair loss lasting at least 6 months and not exceeding 7 years.
- Participants who are WOCBP or male must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD603 during the study,
- AA, Skin Specific, and Other Inflammatory Diseases
- Participants have other types of alopecia (including but not limited to traction, scarring alopecia).
- Participants with "diffuse" type AA.
- Currently has an active form of other inflammatory skin disease(s) or evidence of skin condition (e.g., psoriasis, seborrheic dermatitis, lupus) at the time of the Screening or Baseline (Day 1) visits that is expected...
- Participant has previous severe adverse reaction to subcutaneously administered medication.
- Participant has any of the following liver safety laboratory results at Screening
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal to (\>=) 2.5 × upper limit of normal (ULN)
- Total bilirubin (TBL) \>=1.5 × ULN (TBL \>=3 × ULN in participants with Gilbert's syndrome)
- Alkaline phosphatase (ALP) \>=1.5 × ULN Prior/Concomitant Therapy
- Intention to use any concomitant medication that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication.
The study team makes the final eligibility decision.
Where it's taking place
- Omaha, Nebraska, United States
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Omaha, Nebraska, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.