A Phase Ib/IIa, randomized, double blind, placebo controlled, multicenter clinical trial to evaluate the safety, pharmacokinetics and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis

ONCOSTELLAE S.L.0 sites32 target enrollmentNovember 11, 2019

ConditionsModerate to severe ulcerative colitis Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Moderate to severe ulcerative colitis
Sponsor: ONCOSTELLAE S.L.
Enrollment: 32
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 11, 2019

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ONCOSTELLAE S.L.

Eligibility Criteria

Inclusion Criteria

•1\. Willing and able to provide written informed consent and capable of understanding and complying with the protocol;
•2\. Patients male and female \= 18 and \= 75 years at the time of consent;
•3\. Patient with previous diagnosis of ulcerative colitis: ulcerative proctitis, left\-side ulcerative colitis or extensive/pancolitis (E1, E2 and E3 of Montreal Classification, respectively) established at least 3 months prior to screening and determined by standard clinical, endoscopic, and histological procedures;
•4\. Demonstrated inadequate response, loss of response, or intolerance to at least one of the following treatments including, aminosalicylates (ASAs), corticosteroids, immunosuppressants, anti\-tumor necrosis factor (TNF)\-a agents or integrin inhibitor;
•5\. If the subject is currently receiving an oral aminosalicylate, he or she is eligible and can stay on that dose of aminosalicylate provided the dose has been stable for at least 1 week prior to screening;
•6\. If the subject is currently receiving an oral corticosteroid, he or she is eligible if the dose is equivalent to or less than prednisone 20 mg/day or beclomethasone dipropionate 5 mg/day and stable for at least 1 week prior to screening visit;
•7\. Has an endoscopic Mayo subscore of \= 2 and a total Mayo score of 5\-10 during screening;
•8\. Women who are not postmenopausal (at least 12 months) or surgically sterile must have a negative pregnancy test at screening and at the end of study and either abstain from sexual intercourse or use a highly effective method of birth control (double barrier) for the duration of the study and after 12 weeks after the last dose of study drug;
•9\. For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm for the duration of the study and after 12 weeks from the last dose of study drug;
•10\. Availability for the entire study period, absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; willingness to adhere to the protocol requirements, ability to cooperate adequately and to understand and follow the instructions of the physician or designee

Exclusion Criteria

•1\. Has fulminant colitis, toxic megacolon, primary sclerosing cholangitis, Crohn's disease, history of moderate to severe colitis\-associated colonic dysplasia, active peptic ulcer disease;
•2\. Medications of exclusion:
•a. Topical mesalazine or steroids (i.e., enemas or suppositories) within the 7 days prior to Baseline visit
•b. Azathioprine, 6\-mercaptopurine, or methotrexate within 10 days prior to Baseline visit,
•c. Intravenous corticosteroids within the 14 days prior to Baseline visit,
•d. Tofacitinib or any other JAK inhibitor within 14 days prior to Baseline visit;
•e. Anti\-diarrheal treatment within14 days prior to Baseline Visit.
•f. Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline visit.
•g. Adalimumab within the 30 days prior to Baseline visit
•h. Infliximab, golimumab, etanercept, vedolizumab or certolizumab within the 60 days prior to Baseline visit