Randomized, double-blind and placebo controlled medicinal trial, where efficacy and safety of AMG714 study drug is evaluated in adult patients with celiac disease.
- Conditions
- Celiac diseaseTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-003647-19-FI
- Lead Sponsor
- Celimmune LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Subjects must fulfill all of the following inclusion criteria to be eligible for participation at screening and at Visit 1 (Week 0/Day 0): 1. Adult males or females 18 to 80 years of age, inclusive.
2. Demonstrate willingness to participate in the study as documented by signed informed consent.
3. Subjects must have a diagnosis of celiac disease by intestinal biopsy at least 12 months prior to screening as confirmed by medical records, written physician statement or by the Kela statement, the national social security institution determining the governmental reimbursement for biopsy-proven celiac disease patients.
4. Subjects must have been on a GFD for at least 12 consecutive months prior to screening and must be willing to remain on a GFD for the duration of study participation (apart from the Sponsor-supplied 2g gluten taken BID during the 10-week gluten challenge period of the study).
5. Negative anti-tTG (IgA) at screening.
6. Negative iVYLISA GIP gluten stool test results at screening.
7. Negative H.-pylori test prior to study drug administration.
8. Human leukocyte antigen DQ (HLA-DQ) typing compatible with celiac disease provided or obtained before baseline biopsy.
9. Body mass index (BMI) between 16.0 and 45.0 kg/mPP2PP, inclusive.
10. Screening laboratory values within the following parameters (unless investigator considers an abnormality to be not clinically significant): a) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x the upper limit of normal (ULN). b) Hemoglobin > 10 g/dL (>100 g/L in SI units) c) Platelet count > 125,000 mmPP3PP (>125 /L in SI units). d) White blood cell count > 3,500 cells/mmPP3PP (>3.5 x10PP9PP/L). e) Estimated glomerular filtration rate (eGFR) > 60 ml/min. f) Glycosylated hemoglobin (HbA1C) <7% (<53 mmol/mol) in subjects with a diagnosis of Type 1 or Type 2 Diabetes Mellitus
11. Females of non-childbearing potential defined as postmenopausal (>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone [FSH] level >40 IU/L at Screening); or permanently sterilized (eg, bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, oophorectomy); or otherwise incapable of pregnancy OR Females of child bearing potential (FOCBP) or males who agree to practice two highly effective methods of birth control (as determined by the Investigator; one of the methods must be a barrier technique) from Screening through the end of study participation (Visit 8, Week 16/Day 112) and for 6 months after the end of the study.
12. Willingness and ability to comply with study procedures and protocol stipulated concomitant medication guidelines.
13. Willingness to return for all scheduled follow-up visits.
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 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Subjects will be excluded from the study if there is evidence of any of the following:
1. Current diagnosis of any severe complication of celiac disease, such as Refractory Celiac Disease Type I or Type II (RCD-I or RCD-II), enteropathy-associated T-cell lymphoma (EATL), ulcerative jejunitis or perforation.
2. Diagnosis of any autoimmune disease, other than celiac disease or dermatitis herpetiformis (DH), that might interfere with the conduct of the study or require systemic immunomodulation therapy.
3. Occurrence of celiac disease-related symptoms (CeD-GSRS >2.3) as assessed by screening GSRS.
4. Diagnosis of any chronic, active gastrointestinal (GI) disease other than celiac disease (e.g., active, untreated peptic ulcer, esophagitis, gastroesophageal reflux disease [GERD]; active ulcerative colitis; Crohn’s disease, or irritable bowel syndrome] that might, in the Investigator’s opinion, interfere with assessment of symptoms of abdominal pain, diarrhea, or other components of celiac disease.
5. Any known, symptomatic food allergy, including an allergy to the ingredients of the gluten challenge vehicle that, in the opinion of the Investigator, might interfere with the conduct of the study or result in anaphylaxis.
6. Presence of any of the following related to infection:
a) Active acute infection requiring systemic treatment (antibiotics, antifungal, or antiviral)
b) Active GI infection
c) Persistent or severe infection within the three months prior to randomization
d) History of tuberculosis (TB)
e) Positive Interferon Gamma Release Assay (IGRA) test at screening or known recent exposure (within 6 months prior to screening) to a patient with active TB; subject can be enrolled if he or she has been successfully treated with appropriate chemoprophylaxis.
f) History within 3 years prior to screening of an opportunistic infection typical of those seen in immunocompromised patients (e.g., herpes zoster, systemic candida infection, or systemic fungal infection).
7. Use of systemic immune suppressants (including steroids) within 3 months or 5 half-lives, whichever is longer, prior to randomization.
8. Required use of a prohibited medication at the time of randomization (prohibited medications required for treatment of an AE occurring after randomization are permitted).
9. Current diagnosis or history of cancer within the past 5 years, except successfully treated basal cell or squamous cell carcinoma, cervical carcinoma-in-situ, or early stage prostate cancer.
10. Administration of a live vaccine within 14 days prior to the first administration of study drug.
11. History or presence of clinically significant disease that in the opinion of the Investigator would confound the subject’s participation and follow-up in the clinical trial or put the subject at unnecessary risk, including but not limited to:
a) Cardiovascular disease (e.g., uncontrolled hypertension defined as office systolic blood pressure [BP] equal to or greater than 180 mmHg or office diastolic BP equal or greater than 110 mm/Hg, unstable angina, congestive heart failure worse than New York Heart Association [NYHA] Class II, coronary angioplasty or myocardial infarction within the last 6 months, uncontrolled atrial or ventricular cardiac arrhythmias clinically significant pleural or pericardial effusion or ascites)
b) pulmonary disease (e.g., severe chronic pulmonary disease)
c) renal, hematological, gastrointestinal, endocrine (e.g., poorly controlled diabetes), immunologic, d
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method