A Phase 1 study dosing with a Humira® (adalimumab) Enema in Patients with Active Ulcerative Colitis.

Phase 1

• Conditions: lcerative colitis; Ulcerative colitis; Oral and Gastrointestinal - Inflammatory bowel disease; Inflammatory and Immune System - Other inflammatory or immune system disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620000932965
• Lead Sponsor: Progenity Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-18
• Study Completion: 2021-08-17
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Subject must provide consent to participate in the study prior to any study procedures are performed
- UC diagnosis for at least 3 months. .
- Active colitis:
- Drug stabilisation requirements, if on one or more of the following medications: oral corticosteroid treatment, oral aminosalicylates, Azathioprine or 6 mercaptopurine, Vedolizumab, Tofacitinib, Ustekinumab
- Women of childbearing potential must agree to use birth control

Exclusion Criteria

- Diagnosis of (or clinical findings suggestive of) Crohn’s disease or indeterminate colitis
- Diagnosis of UC limited to rectum
- Evidence of fulminant colitis
- Need for colostomy or ileostomy (within 3 months)
- Previous total or subtotal colectomy or any surgical resection
- Prior exposure to adalimumab
- Prior hypersensitivity reaction to any anti TNF therapy
- Recent or current use of any anti TNF agent
- Current rectal therapy for UC
- Current use of intravenous corticosteroid for UC
- History of renal insufficiency or failure
- History of untreated colonic dysplasia
- Planned surgery over the duration of the study
- History of drug or alcohol abuse
- History of tuberculosis (TB) exposure or latent TB
- Evidence of invasive fungal infections
- History of central or peripheral nervous system demyelinating disorders
- History of congestive heart failure
- Evidence of HIV, hepatitis B, or hepatitis C
- Evidence of active cytomegalovirus (CMV) infection or CMV colitis
- Recent or current need for a live vaccine
- Positive stool culture for enteric pathogens
- Stool positive for Clostridium difficile toxin
- Recent treatment with an investigational (chemical or biological) product
- Women who are lactating or breast-feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified