Bethesda, MDNCT05398809Now EnrollingIRB Ready

Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced) Clinical Trial in Bethesda, MD

Access cutting-edge autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (apeced) treatment through this clinical trial at a research site in Bethesda. Study-provided care at no cost to qualified participants.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (apeced) treatment provided free

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Check if you qualify for this autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (apeced) clinical trial in Bethesda, MD

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Why Participate?

  • No-Cost Study Care

  • Local to Bethesda

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bethesda site if eligible
  4. 4Begin participation

About This Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced) Study in Bethesda

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. Some people with APECED have a type of hair loss called alopecia areata (AA). No drugs are approved to treat AA. Objective: To see if a study drug (ruxolitinib) can help hair regrowth in people with APECED-associated AA and if it can improve other symptoms caused by the immune system s attack to the body. Eligibility: People aged 12 to 65 years with APECED and severe AA. Design: Participants will be in this study for up to 10 months. They will have 5 in-person visits and 6 televisits, each about 4 weeks apart. One in-person visit may be up to a 10-day stay in the hospital. The first in-person visit will include screening. Participants will have a physical exam. They will have blood tests. Photographs may be taken of their skin. They will answer questions about their quality of life. Participants will begin taking the study drug during their hospital stay. They will take the pills by mouth twice a day for 8 months. Researchers may take tissue samples from participants scalp, gums, and lower lip. Participants may provide samples of urine, stool, nail clippings, and saliva. They may have an eye exam and an ultrasound exam of their abdomen. Some tests may be repeated in subsequent in-person visits. In telehealth visits, participants will answer questions about how they are feeling. They will describe and send photos of hair regrowth. They will be asked to have blood drawn and the results sent to the researchers.

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion 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 screening until 12 weeks after the last dose. Highly effective contraceptive measures include:
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 screening.
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 contraception. For family members or household contacts:
Aged \>=18 years.
Lives with the participant.
Proficient in written English.

Exclusion Criteria

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 affect hair regrowth.
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 infection resolution or otherwise recurrent infections of abnormal frequency or prolonged infections suggesting an immune-compromised status as judged by the investigator.
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 screening.
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, may interfere with the participant s ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. There are no exclusion criteria for family members or household contacts.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT05398809) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced) Treatment Options in Bethesda, MD

If you're searching for autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (apeced) treatment options in Bethesda, MD, this clinical trial (NCT05398809) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (apeced) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (apeced) clinical trials near you to find additional studies recruiting in your area.

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