A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

Study CYC-202 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ST-0529 in subjects with moderately to severely active UC, defined as a score of 5 to 9 on the 3-Component Adapted Mayo Score (comprised of rectal bleeding, stool frequency and endoscopy sub-scores; score range 0-9).

Key facts

Study ID

NCT03844932

Run by

Sublimity Therapeutics Holdco Limited

People needed

235

Starts

2019-01-24

Expected to finish

2021-04-14

Last updated by the study team

2021-05-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female adult subjects 18 to 75 years old, inclusive.
• Willing to provide written informed consent and to be compliant with the schedule of study visits and protocol assessments.
• Diagnosis of UC established at least 3 months prior to the Baseline visit, by clinical and endoscopic evidence (colonoscopy or flexible sigmoidoscopy)
• Moderately to severely active UC defined as the 3-Component Adapted Mayo Score of 5-9, inclusive, with an endoscopic sub-score of ≥ 2 (from central reading), and a rectal bleeding sub-score of ≥ 1, as determined 10 days (± 3 days) prior to Baseline.
• Evidence of active UC, confirmed histologically (from local read), extending proximal to the rectum with ≥ 15 cm of involved colon.
• At Screening, a colonoscopy will be required if the subject has had extensive colitis or pancolitis of > 8 years duration or left-sided colitis of > 12 years duration but has not had a colonoscopy within 1 year of the initial screening date. If the subject has had a colonoscopy within 1 year of the initial screening date, a flexible sigmoidoscopy may be used.
• Subjects presenting at Screening with moderately to severely active UC demonstrating an inadequate response or loss of response or intolerance/medical contraindication to at least one of the following conventional therapies for UC:
• a. Corticosteroids:
• i. Signs and symptoms of active disease despite treatment with an adequate dose (e.g., prednisolone > 40 mg/day or equivalent) over a period of 4 weeks for oral therapy or intravenously (IV) for up to 1 week or ≥ 9 mg/day oral budesonide;
• OR
• ii. Unable to reduce corticosteroids below the equivalent of prednisolone 10 mg daily orally within 3 months of starting steroids or having experienced a relapse within 3 months of stopping steroids;
• OR
• iii. History of, or current intolerance to corticosteroids (including, but not limited to Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection).
• b. Immunomodulators:
• i. Signs and symptoms of active disease despite at least 3 months of treatment with a sufficient dose (oral azathioprine ≥ 1.5 mg/kg or 6-mercaptopurine [6-MP] ≥ 0.75 mg/kg);
• OR
• ii. History of, or current dose-limiting toxicity associated with use of the agent (e.g., but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test [LFT] abnormalities, lymphopenia, TPMT genetic mutation, infection).
• c. Anti-tumor necrosis factor (anti-TNF) agents:
• i. Signs and symptoms of active disease despite treatment with a single anti-TNF agent. Treatment failure is defined as a relapse after an initial response to therapy as follows:
• Infliximab: At least 4 infusions of at least 5 mg/kg within a 14-week timeframe for induction and maintenance;
• Adalimumab: Induction regimen incorporating 160 mg at Week 0 (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) and 80 mg at Week 2, followed by maintenance treatment of 40 mg every other week up to at least Week 8;
• Golimumab: Induction regimen incorporating 200 mg subcutaneous (sc) injection at Week 0, followed by 100 mg at Week 2 and then maintenance treatment of 50 mg or 100 mg (weight dependent) every 4 weeks after completion of the induction regimen up to at least Week 12;
• OR
• ii. History of, or current intolerance (with an initial response), defined as the presence of clinically significant side-effects, including infusion-related hypersensitivity.
• d. Vedolizumab:

You may not qualify if…

• If a subject has any of the following criteria, they will be excluded from the study:
• Subjects without previous treatment for UC.
• Ulcerative colitis limited to rectum (ulcerative proctitis).
• Evidence of acute severe colitis with toxic megacolon, abdominal abscess, bowel stricture or bowel perforation.
• A diagnosis of Crohn's colitis, colitis yet to be classified, ischemic colitis, NSAID-induced colitis, idiopathic colitis (i.e., colitis not consistent with UC) or radiation colitis.
• Subjects with evidence of pathogenic bowel infection (Clostridium difficile, Escherichia coli, Salmonella, Shigella or Campylobacter).
• Previous surgery for UC or, in the opinion of the Investigator, will likely require surgery for UC during the study.
• Any histological evidence of mucosal dysplasia.
• Subjects with a current or recent history of severe, progressive or uncontrolled cardiac (including uncontrolled hypertension), renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological (e.g., history of seizures) disease, abnormal magnesium or potassium levels, hypocholesterolemia, or any other severe co-morbidity that, in the opinion of the Investigator, could confound the study results or put the study subject at unreasonable risk.
• Malignancies or history of malignancy within 5 years of the initial Screening visit, with the exception of adequately treated or excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin.
• Any of the following laboratory abnormalities during the screening period - if values are initially outside the prescribed limits, the evaluation may be repeated once within the screening period to determine eligibility:
• Hemoglobin level < 8.0 g/dL
• Absolute WBC count < 3.0 × 10\^9/L
• Absolute Lymphocyte count < 0.5 × 10\^9/L
• Absolute neutrophil count < 1.2 × 10\^9/L
• Platelet count < 100 × 10\^9/L or >1200 × 10\^9/L
• ALT or AST > 2.0 × ULN
• Alkaline phosphatase > 2.0 × ULN
• Serum creatinine > 1.5 × ULN
• Bilirubin > 1.5 × ULN
• Subjects with active TB infection or known history of prior treated or untreated TB infection.
• Subject with a positive serology test result for HIV (HIV type 1 or type 2).
• Subject with a positive serology test result for active HBV or HCV infection.
• Treatment with biologic agents for UC within 56 days or 5 half-lives (whichever is greater) prior to the Baseline visit.
• Treatment with any calcineurin inhibitor (e.g. cyclosporine or tacrolimus) within 28 days prior to the Baseline visit.

Where it is running

• Advanced Research Institute — Largo, Florida, United States
• Advanced Research Institute, Inc. — New Port Richey, Florida, United States
• Endoscopic Research Inc — Orlando, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• AGA Clinical Reasearch Associates, LLC — Egg Harbor, New Jersey, United States
• Baylor College of Medicine — Houston, Texas, United States
• Biopharma Informatic, LLC. — Houston, Texas, United States
• Grodno Regional Clinical Hospital — Grodno, Belarus
• Gomel Regional Clinical Hospital — Homyel, Belarus
• City Clinical Emergency Hospital — Minsk, Belarus
• MedConsult Pleven — Pleven, Bulgaria
• Medical Center Asklepion — Sofia, Bulgaria
• UMBAL Tsaritsa Joanna ISUL — Sofia, Bulgaria
• Dalhousie University - Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada
• London Health Sciences Centre — London, Ontario, Canada
• CHU Amiens Picardie - Service Hépato-Gastroentérologie — Amiens, France
• CHU DE MONTPELLIER - Hôpital St ELOI — Montpellier, France
• CHU de Saint-Etienne - Service de Gastro-Entérologie-Hépatologie — Saint-Etienne, France
• Hôpital de Brabois Service d'Hépato-Gastro-Entérologie — Vandœuvre-lès-Nancy, France
• Eugastro GmbH — Leipzig, Saxony, Germany
• Medizinische Klinik für Gastroenterologie, Infektiologie, Rheumatologie charite — Berlin, Germany
• Krankenhaus Walfriede, Akademisches Lehrkrankenhaus der Charite — Berlin, Germany
• Klinik für Gastroenterologie, Pulmologie und allg. lnnere Medizin — Cologne, Germany
• Agaplesion Markus Krankenhaus Medizinischen Klinik I, Gastroenterologie, Hepatologie, Onkologie, lnfektiologie — Frankfurt, Germany
• Palmtree Clinical Research Inc — Palm Springs, California, United States

Full record on ClinicalTrials.gov

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