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Study of OST-122 in Patients With Moderate to Severe Ulcerative Colitis | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Study of OST-122 in Patients With Moderate to Severe Ulcerative Colitis

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

NCT04353791•Oncostellae S.L

View on ClinicalTrials.gov

Summary

A Phase Ib/IIa to evaluate the safety and tolerability of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis over 28 days. This trial will also explore pharmacokinetics (PK) profile and preliminary therapeutic efficacy associated with OST-122 through biomarker analysis and clinical, endoscopic and histologic assessments.

Detailed Description

OST-122 is an oral, gut-restricted and subtype-selective Jak3/Tyk2/Ark5 inhibitor for the local treatment of inflammatory bowel disease (IBD) including ulcerative colitis, Crohn's disease and, potentially, fibrotic lesions in Crohn's patients. The compound was well tolerated in a Phase 1 study in healthy volunteers and has been shown to be stable during the GI transit, while no significant plasma levels were detected. The gut-restricted PK profile of OST-122 lowers the risk of systemic toxicities inherent to other JAK inhibitors. In the current proof of concept study, the compound's safety, PK profile and trends of efficacy will be investigated in patients with moderate to severe ulcerative colitis.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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)-α agents, integrin inhibitor or anti interleukin 12/23;
•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;
•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:
•1. Topical mesalazine or steroids (i.e., enemas or suppositories) within the 7 days prior to Baseline visit
•2. Azathioprine, 6-mercaptopurine, or methotrexate within 10 days prior to Baseline visit
•3. Intravenous corticosteroids within the 14 days prior to Baseline visit
•4. Tofacitinib or any other JAK inhibitor within 14 days prior to Baseline visit
•5. Anti-diarrheal treatment within 14 days prior to Baseline visit
•6. Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 14 days prior to Baseline visit
•7. Adalimumab within the 14 days prior to Baseline visit
•8. Infliximab, golimumab, etanercept, vedolizumab, ustekinumab or certolizumab within the 14 days prior to Baseline visit
+13 more criteria

Locations (16)

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Reina Sofía

Córdoba, Spain

Hospital Universitari Doctor Josep Trueta

Girona, Spain

Hospital San Jorge

Huesca, Spain

Hospital Infanta Leonor

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Key Dates

Start Date

September 16, 2020

Primary Completion Date

December 27, 2022

Completion Date

December 27, 2022

Last Updated

January 13, 2023

Enrollment

ACTUAL participants

Conditions

Ulcerative Colitis Chronic ModerateUlcerative Colitis Chronic Severe

Interventions

OST-122

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of OST-122 in Patients With Moderate to Severe Ulcerative Colitis

Inclusion Criteria

Exclusion Criteria

R-3750 in Patients With Mild to Moderate Ulcerative Colitis

Lactobacillus Rhamnosus GG (ATCC 53103) in Mild-moderately Active UC Patients

ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis