A Phase 2a, Double-Blind, Placebo Controlled Trial of the Efficacy, Safety and Tolerability of 6-Weeks Treatment With Varying Methods of ALV003 Administration in Patients With Well-Controlled Celiac Disease.

• Conditions: Celiac Disease; MedDRA version: 12.1Level: LLTClassification code 10007864Term: Celiac disease

• Registration Number: EUCTR2010-023127-23-FI
• Lead Sponsor: Alvine Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Age 18 to 75

History of biopsy-proven celiac disease (hospital records or the Social Insurance Institution of Finland, KELA, issued certificate)

Adherence to a gluten-free diet for at least 12 months prior to randomization (documented by medical history)

TG2 antibody negative tested using the rapid point-of-care finger tip whole blood test (Biocard TM Celiac Test, AniBiotech Ltd., Vantaa, Finland)

No history of acute illness for the past 4 weeks

Willing to consume a large meal (e.g. dinner) each day, adhere to a 6-week gluten challenge and undergo 2 on-study upper gastrointestinal endoscopies including multiple biopsies

Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Active dermatitis herpetiformis lesions at the time of screening

History of IgE-mediated reactions to gluten

Any clinical contraindication to performing an endoscopy with intestinal biopsy

Received any systemic biologics within 6 months prior to study start

Taking any oral probiotic supplements (not including probiotics contained in commercially available food preparations)

Use of any immunosuppressive medications 6 months prior to study start

Use of systemic cortisone-like medications within 28-days prior to and during study treatment

History of alcohol abuse or illicit drug use (e.g. amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, etc.) within past 12 months

Laboratory values:
Elevated liver function tests (ALT, AST, Alk Phos and GGT > 2.5 times the upper limit of normal (ULN)
Bilirubin > 1.5 ULN
Serum creatinine > 1.5 ULN
Hemoglobin < 10 g/dL or 100 g/L
Calcium < 2.0 mmol/L
Platelet count < 75.0 x 109 /L or 75,000/mm3
Partial thromboplastin time (PTT) or prothrombin time (PT/INR) > 1.5 ULN
Serum potassium < 3.0 mmol/L, > 5 mmol/L
Total white blood cell count (WBC) < 3.0 x 109/L or 3000/mm3
Total lymphocyte < 1.0 x 109/L or 1000/mm3

Current untreated or active peptic ulcer disease, Grade B or greater esophagitis, motility disorders such as irritable bowel syndrome, functional dyspepsia, inflammatory bowel disease, and symptomatic GERD (gastroesophageal reflux disease) other than celiac disease

Positive pregnancy test at screening and just prior to gluten challenge

Unwilling to practice highly effective birth control (unless surgically sterilized or post-menopausal)

Other than oral contraceptives, use of prescribed meds or over-the-counter medications that in the opinion of the Principal Investigator (PI) might interfere with study results

Current use of anticoagulants, including but not limited to, warfarin sodium, heparin, full-dose aspirin or clopidogrel, during the 7-day period prior to randomization

Received any experimental drug within 14 days of randomization; in the case of experimental biologics at least 6 months prior to randomization

The existence of any uncontrolled chronic disease or condition [for example HIV-AIDS, hepatitis, Type 1 or 2 diabetes, or cancer (other than skin cancer)], other than celiac disease

Uncontrolled complications of celiac disease, which in the opinion of the PI could affect immune response, or pose an increased risk to the patient (e.g. type 1 diabetes or other autoimmune disease)

Known allergy or hypersensitivity to any of the components of the placebo, ALV003, E.coli, or E. coli-derived proteins

Known adverse respiratory effects caused by sulfites

Any medical condition, other than celiac disease, which, in the opinion of the study PI could adversely affect the patient’s participation in the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified