Asphelia Trichuris Suis Ova in Moderately Active Crohn's Disease

Phase 2

• Conditions: Crohn's Disease; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12608000241336
• Lead Sponsor: Asphelia Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Diagnosis of CD involving the ileum, colon, or ileum and colon of
at least 6 months in duration as determined by medical history
2. CDAI (Crohn's Disease Activity Index)= 220 and = 350, as scored from 7 days during the
Screening period
3. Must have had colonoscopy with no significant findings and with
findings consistent with CD within 6 months of study entry
(Week 0)
4. Male or female, age 18 to 70 years, inclusive
5. 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),
6-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)

6. Able to read, understand, and sign an ethics committee approved
informed consent form

Exclusion Criteria

1. Patients whose CD was diagnosed more than 5 years ago
2. Patients whose CD is anticipated to require surgical, endoscopic,
or radiologic intervention while on study
3. Hospitalization for CD within the last 2 months or at risk for
hospitalization secondary to CD within the next 2 months
4. CD requiring total parental nutrition (TPN)
5. Evidence of bowel obstruction within 3 months of Screening
6. Symptomatic stricture of the small or large intestine within 3
months of study entry (Week 0)
7. Active fistula not adequately drained or non-perianal fistula
8. Intestinal or abdominal abscess
9. 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.
10. Ileostomy or colostomy
11. Uncontrolled gastrointestinal (GI) bleeding
12. Short bowel syndrome
13. Diagnosis of ulcerative colitis
14. Scleroderma
15. Asthma necessitating daily controller medication
16. Clinically detectable splenomegaly
17. Positive stool culture for C difficile toxin A or B, bacterial enteric
pathogens, rotavirus, cryptosporidium species or pathogenic
ova/parasites
18. Co-infection with Campylobacter jejuni
19. 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)
20. 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)
21. Current or recent serious systemic disorder including clinically
significant impairment in cardiac, pulmonary, liver, renal,
endocrine, hematologic, or neurologic function
22. Positive for human immunodeficiency virus (HIV)
23. Any condition associated with significant immunosuppression
24. 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
25. Receipt of any investigational agent within the past 12 weeks
from study entry (Week 0)
26. Blood transfusion within the past 3 months from study entry
(Week 0)
27. Current or prior malignancy within five years, excluding non-
melanoma skin cancer, or precancerous dysplasia
28. Positive for Hepatitis BsAg or Hepatitis C antibody
29. 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified