Celiac Disease MedDRA version: 12.1 Level: LLT Classification code 10007864 Term: Celiac disease
Conditions
Interventions
Product Name: ALV003
Product Code: ALV003
Pharmaceutical Form: Oral powder
Other descriptive name: ALV001
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 450-
Other
Sponsors
Alvine Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 1.5 ULN Serum potassium 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy endpoint of this study is change in intestinal mucosal morphology as determined by changes in villus height to crypt depth ratio from baseline to post treatment. Primary safety endpoints: * Safety and tolerability of ALV003 * Pharmacokinetics of ALV003 * Antibody response to ALV003;Secondary Objective: Secondary efficacy endpoints include change from baseline to post treatment of: * Change in small bowel mucosal inflammation * Density of intraepithelial lymphocutes * IgA deposist on TG2 * Change in serologic markers of celiac disease * IgA class TG2 antibodies * IgA and IgG class deamidated gliadin peptide antibodies * Serum IgA class endomysial antibodies ;Primary end point(s): Primary Efficacy Endpoint: Intestinal mucosal morphology * Change from baseline to post-treatment in villus height to crypt depth ratio Primary Safety End Points: * Safety and tolerability of ALV003 * Pharmacokinetics of ALV003 * Antibody response to ALV003 | — |
Countries
Finland
Outcome results
None listed