The Efficacy of Denosumab in Active Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02321280
• Date of registration: 11/12/2014
• Prospective Registration: Yes
• Primary sponsor: University of Manitoba
• Public title: The Efficacy of Denosumab in Active Crohn's Disease
• Scientific title: Denosumab (A Monoclonal Antibody to Receptor Activator of Nuclear Factor-Kappa B Ligand (RANKL) in Crohn's Disease
• Date of first enrolment: February 2015
• Target sample size: 2
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02321280
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Canada

Contacts

• Name: Charles N Bernstein, MD
• Affiliation: University of Manitoba

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject has provided informed consent.

2. Male or female subjects, 18 to 80 years of age, inclusive.

3. Prior diagnosis of CD confirmed by endoscopy or imaging for > 3 months prior to
enrollment with active disease, defined as a Crohn's Disease Activity Index (CDAI)
score >220 to <450 and at least one of either: fecal calprotectin >250 ug/g feces, or
CRP >8 mg/L.

4. Patients will have evidence of ileocolonic, colonic, or ileal disease that is
visualized either endoscopically or on MRI within the prior 6 months.

5. Patients must carry at least one G allele at rs2062305.

6. Patients will be eligible for the study if they are receiving any of the following:

- mesalamine for >8 weeks with the dose remaining stable for 4 weeks prior to
screening;

- a maximum of 20 mg of prednisone per day (or steroid equivalent), with the dose
remaining stable for 2 weeks prior to screening. Steroids must be held stable for
the first 4 weeks of the study and then must be tapered by 5 mg per week, to be
discontinued entirely by week 8;

- 6-mercaptopurine, methotrexate or azathioprine for =3 months, with the dose
remaining stable for 8 weeks prior to screening;

Exclusion Criteria:

1. Monoclonal antibody or experimental agent use within 12 weeks before screening.

2. Use of non-approved drugs for CD.

3. Anticipated need for surgery within 12 weeks

4. Active sepsis, or use of antibiotics within two weeks prior to screening for the
treatment of infection.

5. Pregnant, lactating or planning to become pregnant during the study

6. Inability to reliably use birth control for men and women during the course of
therapy.

7. Known allergy to Denosumab or ingredients in formulation

8. Treatment of cancer within the last 5 years (except for non-melanoma skin cancers).

9. Recent jaw infection, invasive dental procedures (tooth extraction, dental implants or
surgery), anti-angiogenic medications, or hypocalcemia within 1 month prior to
screening.

10. Patients will also be excluded if they meet any of the following criteria:
Proctocolectomy or total colectomy; stoma; a history of allergy to murine proteins; or
treatment with parenteral corticosteroids or corticotropin within four weeks before
screening. Serum Hg < 80 g/L, liver enzymes = 2-fold elevated, or other serum
biochemistry considered unsafe, or requiring treatment, in the opinion of the
investigator.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Denosumab

Primary Outcome(s)

Disease Response [Time Frame: week 12]

Secondary Outcome(s)

Endoscopy score decrease [Time Frame: week 12]

Safety will be assessed for any unforeseen adverse events at each study visit [Time Frame: week 12]

MRI improvement [Time Frame: week 12]

fecal calprotectin decrease [Time Frame: week 12]

CRP decrease [Time Frame: week 12]

Disease Remission [Time Frame: week 12]

Secondary ID(s)

DIC 2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Toronto

McMaster University