Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Study phase:

    II What is this?

    During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

  • Site IRB:

    • Scottsdale/Phoenix, Arizona: 12-009541
    • Jacksonville, Florida: 12-009541
    • Rochester, Minnesota: 12-009541
  • NCT ID:

    NCT01917630
  • Sponsor Protocol Number:

    ALV003-1221

About this study

To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Ages 18 to 80 years
  • Physician diagnosed celiac disease
  • Adherence to a gluten-free diet
  • Experiencing symptoms of celiac disease over a 1-month period
  • Willing to take study medication for 12 weeks
  • Willing to comply with all study procedures
  • Sign informed consent

Exclusion Criteria:

  • Active inflammatory bowel disease
  • Active dermatitis herpetiformis
  • Use of certain specific medications prior to entry
  • History of alcohol or illicit drug abuse in previous 6 months
  • Pregnant or lactating
  • Received any experimental drug within 30 days of enrollment
  • Uncontrolled chronic disease or condition

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Vandana Nehra, M.D.

Status Unknown

Narcelle Jean-Louis

(480)301-4714

JeanLouis.Narcelle@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Vandana Nehra, M.D.

Status Unknown

Verna Skinner CCRP

(904)953-8982

Skinner.Verna@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Vandana Nehra, M.D.

Status Unknown

Carol Van Dyke CCRP

(507)266-7842

vandyke.carol@mayo.edu