Asphelia Trichuris Suis Ova in Moderately Active Crohn's Disease
A Randomized, Double-Blind, Placebo-Controlled, Trial Of Asp1002 (Trichuris Suis Ova [Tso]) Therapy For Moderately Active Crohn’s Disease
Asphelia Pharmaceuticals Inc.
60 participants
Jun 30, 2008
Interventional
Conditions
Summary
Inflammatory bowel disease (IBD) is a chronic, relapsing condition of the gastrointestinal (GI) tract. IBD is thought to result from inappropriate T cell activation due to a combination of genetic and environmental factors. This leads to a deregulated immune response and characteristic inflammation. Crohn’s disease (CD) is a form of IBD. One theory suggests that underexposure to helminths is a major environmental factor in predisposing to CD. This “hygiene hypothesis” is based on epidemiologic findings of an inverse relationship between IBD incidence and helminthic colonization. In the proposed study, the pig whipworm Trichuris suis (T. suis), formulated as ASP1002 [Trichuris suis Ova (TSO)], a suspension for oral administration, will be administered in the clinic as a single dose for 6 times. T. suis is similar morphologically to the human whipworm but is cleared too rapidly from the human host to establish infection. Therefore, it has potential for being a natural immune modulator without significant risk of causing disease in humans. The expected duration of study participation is approximately 26 to 27 weeks, including up to 2 - 3 weeks screening, a 12 week treatment period and a follow-up visit at Week 24.
Eligibility
Inclusion Criteria24
- Diagnosis of CD involving the ileum, colon, or ileum and colon of
- at least 6 months in duration as determined by medical history
- CDAI (Crohn's Disease Activity Index)= 220 and = 350, as scored from 7 days during the
- Screening period
- Must have had colonoscopy with no significant findings and with
- findings consistent with CD within 6 months of study entry
- (Week 0)
- Male or female, age 18 to 70 years, inclusive
- If on the following medications at Screening Visit 1, patients must
- meet the following criteria:
- a. Corticosteroids: stable treatment for at least 4 weeks prior to
- study entry (Week 0) with a maximum dose of 15 mg/day
- b. Immunosuppressants [azathioprine (AZA),
- -mercaptopurine (6-MP), methotrexate (MTX)]: treatment
- for at least 3 months with a stable dose for four weeks prior to
- study entry (Week 0)
- c. Antibiotics: ciprofloxacin can be continued at a stable dose
- for up to two weeks if the patient is on treatment at Screening
- Visit 1
- d. Anti-inflammatory: Mesalamine can be continued if the
- patient has been on a stable dose (up to 1.2 gms/daily) for 6
- weeks prior to study entry (Week 0)
- Able to read, understand, and sign an ethics committee approved
- informed consent form
Exclusion Criteria89
- Patients whose CD was diagnosed more than 5 years ago
- Patients whose CD is anticipated to require surgical, endoscopic,
- or radiologic intervention while on study
- Hospitalization for CD within the last 2 months or at risk for
- hospitalization secondary to CD within the next 2 months
- CD requiring total parental nutrition (TPN)
- Evidence of bowel obstruction within 3 months of Screening
- Symptomatic stricture of the small or large intestine within 3
- months of study entry (Week 0)
- Active fistula not adequately drained or non-perianal fistula
- Intestinal or abdominal abscess
- History of bowel resection of any length in the last 6 months from
- study entry (Week 0) or total bowel resection(s) > 100 cm.
- Patients with total bowel resection(s) = 100 cm can be enrolled
- provided that the Screening fecal calprotectin level is 100 mcg/g
- feces to confirm that the bowel symptoms (i.e., diarrhea) are
- linked to CD and not to short bowel syndrome.
- Ileostomy or colostomy
- Uncontrolled gastrointestinal (GI) bleeding
- Short bowel syndrome
- Diagnosis of ulcerative colitis
- Scleroderma
- Asthma necessitating daily controller medication
- Clinically detectable splenomegaly
- Positive stool culture for C difficile toxin A or B, bacterial enteric
- pathogens, rotavirus, cryptosporidium species or pathogenic
- ova/parasites
- Co-infection with Campylobacter jejuni
- Women, who are pregnant, breast feeding or planning to become
- pregnant during the study. All women of childbearing potential
- must have a negative serum pregnancy test prior to study entry
- (Week 0)
- Men and women of children bearing potential not using adequate
- birth control measures (e.g., abstinence, oral contraceptives,
- intrauterine device, barrier method with spermicide, or surgical
- sterilization)
- Current or recent serious systemic disorder including clinically
- significant impairment in cardiac, pulmonary, liver, renal,
- endocrine, hematologic, or neurologic function
- Positive for human immunodeficiency virus (HIV)
- Any condition associated with significant immunosuppression
- Patients currently receiving the following concomitant
- medications:
- a. Prednisone or its equivalent, greater than 15 mg/day
- b. Local steroids such as budesonide, Colifoam, and Predsol
- enemas
- c. Non-steroidal anti-inflammatory drugs (NSAIDS),
- Cyclooxygenase (COX)-2 inhibitors, or aspirin
- >100 mg/day within 1 week of study entry (Week 0)
- d. TNF-alpha inhibitors such as infliximab (Remicade®),
- adalimumab (Humira®) or other biological agents within 3
- months of study entry (Week 0)
- e. Metronidazole
- Receipt of any investigational agent within the past 12 weeks
- from study entry (Week 0)
- Blood transfusion within the past 3 months from study entry
- (Week 0)
- Current or prior malignancy within five years, excluding non-
- melanoma skin cancer, or precancerous dysplasia
- Positive for Hepatitis BsAg or Hepatitis C antibody
- Presence of the following abnormal laboratory parameters at
- Screening:
- a. Hemoglobin < 10.0 g/dL. The hemoglobin may be retested
- one time prior to study entry (Week 0) if the first screening
- test is < 10.0 g/dL
- b. White blood Count (WBC) < 4,000 or > 20,000/mm3
- c. Platelets < 100,000 or > 800,000/mm3
- d. Amylase or lipase > 2 × upper limit of normal (ULN)
- e. Total bilirubin > 1.5 × ULN
- f. Alanine transaminase (ALT) and aspartate transaminase
- (AST) > 2 × ULN
- g. Alkaline phosphatase (ALK) or gamma glutamyl transferase
- (GGT) > 1.5 × ULN
- h. Creatinine > 1.5 × ULN
- Known vitamin B12 deficiency (unless treated greater than one
- month prior to study entry [Week 0])
- Iron saturation level of less than 15%. The patient may be treated
- and re-screened for participation provided that no iron
- transfusions would be required during the study.
- Current drug or alcohol abuse that may interfere with the
- objectives of the study
- Inability to comply with the planned schedule of study visits
- Inability to understand the nature and requirements of the study,
- or to comply with the study procedures
- Any social or medical condition that, in the opinion of the
- investigator, would preclude provision of informed consent, make
- participation in the study unsafe, complicate interpretation of
- study outcome data, or otherwise interfere with achieving the
- study objectives.
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Interventions
15ml(167eggs/ml) oral Asp1002 (Trichuris Suis Ova [Tso]) taken every fortnight for 12 weeks.
Locations(1)
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ACTRN12608000241336