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Tests treatment safety and results for Autoimmune Polyendocrinopathy Candidiasis Ectodermal...
Official title Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
ClinicalTrials.gov ID: NCT05398809
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (apeced).
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
- Background: Autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (APECED) is a problem of the immune system. In people with APECED, the immune system makes a mistake and attacks the body.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 10 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 75. Healthy volunteers may be eligible.
You may be able to join if
- For participants with APECED-associated AA:
- Participant must be able to understand and provide informed consent.
- Aged \>=12 to \<=75 years.
- Patients with APECED (genetic or clinical diagnosis) and severe AA (defined as having \>=50% total scalp loss at screening per the SALT score).
- Duration of hair loss greater than 6 months.
You likely can't join if
- For participants with APECED-associated AA:
- Known history of hypersensitivity to ruxolitinib or other JAK inhibitors.
- History of or active skin disease on the scalp other than AA, such as psoriasis or seborrheic dermatitis.
- Diagnosis of AA is in question or the pattern of hair loss is such that quantification of hair loss and assessment of regrowth is difficult, eg...
- Treated within the last 2 months with intralesional steroids, systemic steroids, anthralin, squaric acid, diphenylcyclopropenone, tacrolimus...
- Current or recent use of any investigational drug (within 3 months or 5 half-lives, whichever is longer, prior to screening).
See the full eligibility criteria
- For participants with APECED-associated AA:
- Participant must be able to understand and provide informed consent.
- Aged \>=12 to \<=75 years.
- Patients with APECED (genetic or clinical diagnosis) and severe AA (defined as having \>=50% total scalp loss at screening per the SALT score).
- Duration of hair loss greater than 6 months.
- No present evidence of hair regrowth.
- Is na(SqrRoot) ve or unresponsive to other treatments for AA.
- No treatment for alopecia in the past 2 months prior to study enrollment.
- Willingness to use valacyclovir prophylaxis for the prevention of herpes viral reactivation.
- Vaccinations should be up to date in agreement with current CDC immunization guidelines prior to start of ruxolitinib.
- Proficient in written English.
- Participants who can get pregnant or impregnate their partner must agree to use at least one highly effective method of contraception when engaging in sexual activities that can result in pregnancy, starting at...
- Stable use of combined (estrogen- and progestogen-containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) starting 1 month prior to...
- Intrauterine device; intrauterine hormone-releasing system.
- Two barrier methods (eg, condom with spermicide, diaphragm with spermicide, or cervical cap and spermicide). Internal and external condoms may not be used together.
- Bilateral tubal ligation. Periodic abstinence (calendar, symptothermal, and post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of...
- Aged \>=18 years.
- Lives with the participant.
- Proficient in written English.
- For participants with APECED-associated AA:
- Known history of hypersensitivity to ruxolitinib or other JAK inhibitors.
- History of or active skin disease on the scalp other than AA, such as psoriasis or seborrheic dermatitis.
- Diagnosis of AA is in question or the pattern of hair loss is such that quantification of hair loss and assessment of regrowth is difficult, eg, patients with androgenic alopecia.
- Treated within the last 2 months with intralesional steroids, systemic steroids, anthralin, squaric acid, diphenylcyclopropenone, tacrolimus, minoxidil, or other medication that, in the opinion of the investigator, may...
- Current or recent use of any investigational drug (within 3 months or 5 half-lives, whichever is longer, prior to screening).
- Scheduled to participate in another clinical study involving an investigational drug during the course of this study.
- Use of systemic immunosuppressive or immune-modulating agents within 3 months prior to screening, except systemic steroids 10 mg of prednisone equivalent per day.
- Current use of systemic steroids with daily dose \>10 mg of prednisone equivalent for any reason or steroid burst for \>3 days within 1 month of screening.
- History of alcohol or drug abuse within 6 months prior to screening.
- Presence of one or more of the following clinically significant laboratory abnormalities:
- Serum ALT\>=3 times upper limit of normal (ULN).
- Serum total bilirubin \>=2 times ULN.
- ANC\<=1000 cells/microliter.
- Hemoglobin \<=9.0 g/dL.
- Platelet count \<=100,000/microliter.
- Serum creatinine \>=2 times ULN.
- Planned or anticipated major surgical procedure during the study.
- Plans to receive any live vaccines within 1 month of the anticipated first dose of ruxolitinib.
- Known or suspected immunodeficiency disorder besides APECED.
- History of untreated invasive opportunistic infections (eg, tuberculosis, non-tuberculous mycobacterial infections, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, aspergillosis) despite...
- Untreated latent tuberculosis infection.
- Infection with HIV.
- Untreated infection with hepatitis B or C.
- History of serious bacterial infection within the last 3 months prior to screening, unless treated and resolved with antibiotics, or any chronic bacterial infection (eg, chronic pyelonephritis, osteomyelitis).
- History of unprovoked DVT, PE, arterial thrombosis, or other thrombotic events.
- History of stroke, heart attack, or heart failure.
- History of herpes zoster or cytomegalovirus infection that resolved within 2 months prior to screening.
- History of basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix, unless the participant is in remission and curative therapy was completed at least 12 months prior to...
- History of other malignancies, unless the participant is in remission and curative therapy was completed at least 5 years prior to screening.
- Planned or anticipated use of any prohibited medications and procedures during the study.
- Current pregnancy or breastfeeding.
- Past or current medical problems or findings from physical examination, EKG, or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 10 months 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, 12 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, 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.