A multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after multiple dose administration in participants with celiac disease.
- Conditions
- autoimmune and inflammatory diseasesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonCoeliac diseaseInflammatory and Immune System - Autoimmune diseases
- Registration Number
- ACTRN12624000974505
- Lead Sponsor
- Forte Biosciences, Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 32
1.Men and women aged greater than or equal to 18 to 65 years at screening.
2.Has documented diagnosis of celiac disease confirmed by intestinal biopsy and positive celiac serology at least 12 months prior to Screening (intestinal biopsy and serology do not have to be performed concurrently).
3. Body mass index (BMI) between 16.0 and 32.0 kg/m2, inclusive.
4.Weight greater than or equal to 50 kg and less than or equal to 100 kg for men and greater than or equal to 45 kg and less than or equal to 95 kg for women
5.Self-reported to be on a GFD for at least 12 months prior to Screening and must be willing to remain on a GFD for the duration of study participation, with the exception of the oral gluten challenge administered as a study procedure.
6.Normal or negative celiac serology at Screening defined as follows:
a.Measurable total serum immunoglobulin A (IgA), AND
b.Negative or weak positive tissue transglutaminase (tTG) immunoglobulin A (IgA) titer, OR
c.If IgA deficient, defined by a serum IgA level of less than 3 mg/dL, negative or weak positive DGP-IgG titer.
7.Human leukocyte antigen DQ (HLA-DQ) genotyping compatible with celiac disease (HLA DQ2/DQ8) provided or obtained before baseline EDG with biopsies.
8.Vh:Cd greater than 2.0 on Screening biopsies.
Note: EGD with biopsies to be performed only after other initial screening activities are performed that indicate the participant is a candidate for randomization and must be done no later than Day -7 of Screening to allow for biopsy results.
9.If taking a prescription or over the counter medication or supplement with gastrointestinal effects (e.g., laxative, fiber supplements, herbal remedies, etc.), must be at stable regimen for at least 3 months prior to Screening.
10.Men must agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior and documented to no longer produce sperm – verbal confirmation through medical history review acceptable); or agree to use a condom plus effective contraception (i.e. established use of hormonal contraception started at least 30 days prior to Day 1; or placement or an intrauterine device or intrauterine system) for their female partner, if of childbearing potential, from screening and for at least 90 days after dosing and refrain from donating sperm during this period. These contraception requirements do not apply if the male participant is in an exclusively same sex relationship.
11.Women are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
a.Not of childbearing potential, defined as surgically sterile (hysterectomy, bilateral salpingectomy, bilateral tubal ligation or bilateral oophorectomy – verbal confirmation through medical history review is acceptable).
b.Postmenopausal (no menses for 12 months and confirmed by FSH level greater than or equal to 40 mlU/mL).
c.Of childbearing potential and agree to practice true abstinence or agrees to use a highly effective method of contraception consistently from 30 days prior to Day 1 until the end of study. Must also agree not to donate ova during the study and for 100 days after the end of study.
NOTE: Highly effective contraception includes hormonal contraception (oral, injected, implanted or transdermal) plus use of a condom, placement of an intrauterine device or intrauterine system plus use of a condom, or a vasectomized male partner (performed at least 6
1. Uncontrolled CeD and/or active signs/symptoms of CeD, in the opinion of the Investigator.
2. History of or current neuropsychiatric manifestations including ataxia and peripheral neuropathy related to gluten exposure.
3. History of or current diagnosis of any severe complication of celiac disease. such as Refractory Celiac Disease Type l or Type II (RCD-1 or RCD-11). Enteropathy-associated T-cell lymphoma (EATL) ulcerative jejunitis or perforation.
4. History or presence of skin manifestations of CeD such as dermatitis herpetiformis at any time.
5. Diagnosis of any autoimmune disease, other than celiac disease, that might interfere with the conduct of the study or require systemic immunomodulation therapy.
6. 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, diarrhoea, or other components of CeD.
7. Any other known symptomatic food allergy (e.g., tree nuts, etc.) or intolerance (e.g., lactose intolerance, etc.) that, in the opinion of the Investigator, might interfere with the conduct of the study or result in anaphylaxis.
8. History of a severe reaction to wheat or gluten exposure (anaphylaxis, hospitalization, prolonged moderate or severe symptoms greater than 3 days after a single exposure).
9. Participant not a good candidate or is at increased risk to undergo two EGDs with associated biopsies during the course of the study, as assessed by the Investigator.
10. Severe infection within the three months prior to Day 1.
11. Positive for hepatitis B surface antigen (HbsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies at Screening.
12. Received a live vaccine within 4 weeks of Screening.
13. Use of systemic immune suppressants (including corticosteroids) within 3 months or 5 half-lives, whichever is longer, prior to Day 1. Inhaled corticosteroids for respiratory diseases such as asthma. and topical corticosteroids are permitted.
14. Use of oral pharmaceutical presentations (e.g., capsules, powders) of probiotic or prebiotic supplements less than or equal to 7 days prior to Day 1 (foods such as yogurt or kefir are acceptable).
15. History or presence of any form of cancer within the 5 years prior to screening, with the exception of excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ such as cervical or breast carcinoma that has been excised or resected completely and is without evidence of local recurrence or metastasis.
16. Must not have the following laboratory criteria during Screening:
a. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 2.5 x the upper limit of normal.
b. Total bilirubin greater than 1.5x the upper limit of normal (ULN). Participants with a bilirubin greater than 2x ULN that have a documented diagnosis of Gilbert’s syndrome may be enrolled at the Investigator’s discretion.
c. Serum creatinine greater than 2.0 mg/dL or creatinine clearance less than 60 m L/ min measured or calculated by Cockroft-Gault equation.
d. Screening neutrophil count less than 3.5 x 109/L.
e. Screening platelet count less than 125 x 109/L.
f. Screening haemoglobin (Hgb) less than 10.0 g/dL.
g. Glycosylated h
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method