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NSCIBD Clinical Studies


DUET: Ulcerative Colitus

The purpose of the DUET-UC study is to see if the combination of guselkumab and golimumab is safe and effective for treating patients with moderately to severely active Ulcerative Colitis. We are looking for participants who have had a diagnosis of moderate to severe Ulcerative Colitis for at least three months.

The treatments being studied in this clinical trial are called guselkumab, golimumab and a combination of both currently known as JNJ-7893480.

Guselkumab works by blocking an inflammatory protein made by the immune cells called interleukin (IL)-23 and Golilumab works by blocking an inflammatory protein made by immune cells called tumor necrosis factor (TNF). JNJ-78934804 works by blocking both IL-23 and TNF.

It has been proposed that combination therapies, such as JNJ-78934804 may be more effective in inducing and maintaining remission in Ulcerative Colitis than monotherapies (one treatment).

Inclusion Criteria:

  • Ulcerative Colitis (UC) for at least 3 months prior to baseline
  • Confirmed diagnosis of moderate to severe UC as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
  • Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Ulcerative Colitis (UC)
  • If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion Criteria:

  • Complications of UC that may be anticipated to require surgery
  • Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
  • Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks
  • Has a draining (example, functioning) stoma or ostomy
  • Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for greater than or equal do (>=) 12 months before the first dose of study intervention)
  • Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer

GARNET: MORF-057 for Crohn's Disease

Currently, there are a number of conventional and advanced therapy options available to treat Crohn’s Disease. These include corticosteroids, immunomodulators, and anti-inflammatory biologic agents such as infliximab, adalimumab, vedolizumab, and ustekinumab. Despite these advances, there remains an unmet need in the treatment of Crohn’s Disease. Even with the best available approved therapies, many patients with Crohn’s Disease fail to achieve clinical remission (disappearance of signs and symptoms of CD), with even fewer achieving endoscopic remission (no evidence of inflammation in the intestine during a scope). 

Specific inhibition of a4ß7 (the mechanism of action of MORF-057) is a validated mechanism for the treatment of Crohn’s Disease as demonstrated by vedolizumab (Entyvio®), an approved treatment for Crohn’s Disease. Like MORF-057, Vedolizumab is a monoclonal antibody. It is administered via intravenous infusion or subcutaneous injection. MORF-057 is a small molecule designed to selectively inhibit integrin a4ß7 and is administered orally. Thereby, avoiding the need for periodic therapeutic infusions and injections and the complications associated with these forms of drug administration.

This trial will expand prior research to see if MORF-057 would be a feasible new treatment option for moderate to severe Crohn's Disease.

Inclusion Critera:

  • Moderate to severe Crohn’s Disease (defined as a CDAI score of 220-450 inclusive, with an SES-CD score of ≥6. If the disease is isolated to the ileum, the requirement will be an SES-CD score ≥4)
  • Demonstrated inadequate response, loss of response, or intolerance to at least one conventional therapy and/or no more than three drugs in two classes of advanced therapy

Exclusion Criteria:

  • Any previous treatment with vedolizumab or other licensed or investigational integrin pathway inhibitors

M23-274: Risankizumab Subcutaneous Induction Treatment

Risankizumab is a monoclonal antibody which means that it is the same as a protein in the body, called an antibody.  It works by blocking the actions of a protein known as Interleukin 23. Interleukin 23 is involved in the immune response and plays an important role in the development of chronic inflammation; such as the inflammation that causes the symptoms of Crohn's Disease.  

Prior Phase 3 clinical trials have shown that Risankizumab is a safe and effective treatment option for patients with moderate to severely active Crohn's Disease.  It is currently approved by Health Canada as an intravenous induction therapy (therapy to induce remission) for moderate to severe Crohn’s Disease followed by a subcutaneous maintenance regimen. The purpose of this study is to see if risankizumab given subcutaneously (administered under the skin) to induce remission (induction therapy) is a safe and effective way to treat moderate to severe Crohn's disease. Thereby providing patients with an alternative dosing option to IV therapy for induction treatment.

Inclusion Criteria:

  • Moderate to severe Crohn’s Disease (defined as a CDAI score of 220-450 inclusive, with an SES-CD score of ≥6. If the disease is isolated to the ileum, the requirement will be an SES-CD score ≥4)
  • Must have failed or been intolerant to at least one conventional or advanced therapy

UPLIFT (P23-899): Post-marketing study of Upadacitinib fo Crohn's Disease

Upadacitinib is a selective and reversible Janus kinase (JAK) inhibitor recently licensed for the treatment of several immune-mediated inflammatory diseases, including moderately to severely active ulcerative colitis (UC). While there is substantial evidence from clinical trials to support the use of upadacitinib in the treatment of Crohn's Disease (CD), the drug's effectiveness and safety in the real world are largely unknown. This study will evaluate the speed of onset and durability of effectiveness; long-term effectiveness; long-term safety; impact on steroid use; and treatment utilization patterns in CD patients in real-world clinical practice settings.This is a multi-country, prospective, open-label, post-marketing real-world study of patients with moderate-to-severe Crohn's Disease starting Upadacitinib at the investigator’s discretion and independent of study enrollment. Upadacitinib will be administered in accordance with the terms of the local marketing authorization and treatment of patients will be determined by the investigator.

As this is a real-world study, visits should occur according to routine clinical practice, with Visit 1 (Baseline) occurring at the time upadacitinib is prescribed. Recommended subsequent study assessments are structured to align with the most common routine clinical monitoring approach of 12 weeks (at the end of the induction period), 6 months (26 weeks) after treatment initiation (Note: for patients who do not achieve clinical response after 12 weeks of 45 mg induction and who are prescribed 30 mg, this visit will also be at Week 24-26, depending on clinical practice (Visit 2A), and Week 24-26 data will be analyzed as postinduction), and every 6 months thereafter.

Inclusion Criteria:

  • Moderate to severe Crohn’s Disease (defined as a CDAI score of 220-450 inclusive, with an SES-CD score of ≥6. If the disease is isolated to the ileum, the requirement will be an SES-CD score ≥4)
  • Starting upadacitinib independent from study participation

 Interested in learning more about these clinical studies?

Please contact Lorena Morrison (Research Manager) or Shari Smith (Senior Clinical Research Coordinator) at:

Centre for Clinical Research
5790 University Avenue Room 321D
Halifax, NS B3H 1V7
Office: 902-473-6861
Fax: 902-473-5889
lorenaf.morrison@nshealth.ca or Shari.Smith@nshealth.ca 

Where to find us

9th Floor Victoria Building
Halifax, Nova Scotia
B3H 2Y5


Fax: 902-473-4406