Moderate to severe ulcerative colitis
Conditions
Interventions
Product Name: OST-122
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not available yet
Other descriptive name: OST-122
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
ONCOSTELLAE S.L.
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
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 i. NSAIDs on a daily basis withdrawn 7 days previous to Baseline visit 3. Has a current bacterial, parasitic, fungal, or viral infection 4. Is positive for hepatitis A, B or C, HIV or tuberculosis, as assessed by method available at each site 5. Patient who has clinically significant diseases and/or infections captured in the medical history or evidence of clinically significant findings on physical examination and/or clinically significant ordinary laboratory evaluations (haematology, biochemistry, and urinalysis) or ECG. 6. Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Baseline (or within 60 days prior to Baseline if investigational drug was a biologic product) 7. Demonstrated an inadequate response or loss of response to Tofacitinib or any other JAK inhibitor. 8. Use of products, food supplements or medical devices, whose composition includes probiotics in the 1 month prior to Baseline visit. 9. Patient who has prior extensive colonic resection, subtotal or total colectomy or planned surgery for ulcerative colitis 10. Patient who has past or present fistula or abdominal abscess 11. Patient who is pregnant or lactating 12. Inability to comply with study protocol, in opinion of the investigator 13. History of alcohol, drug or chemical abuse within 6 months prior to Screening visit 14. History of cancer within the last 5 years. Patients with local basal or squamous cell carcinoma of the skin that has been excised and is considered cured may be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial primary goal will be to evaluate the safety of OST-122 in patients with moderate to severe active ulcerative colitis disease over 28 days;Secondary Objective: Explore the pharmacokinetics (PK) profile and preliminary therapeutic efficacy associated with OST-122 through biomarker analysis and clinical assessments;Primary end point(s): Safety: - Number, severity, and type of AE, including changes in vital signs, physical examination, safety laboratory values, and ECGs - Causality with IMP as assessed by the investigator;Timepoint(s) of evaluation of this end point: Safety of OST-122 administered for 28 days by assessing the Number, severity, and type of AE, including changes in vital signs, physical examination, safety laboratory values, ECGs and causality with IMP as assessed by the investigator | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: - Subjects (%) with improvement of rectal bleeding subscore by =1 point (Day 28) - Subjects (%) with rectal bleeding subscore of 0-1 (Day 28) - Subjects (%) with improvement of stool frequency subscore by =1 point (Day 28) - Subjects (%) with stool frequency subscore of 0-1 (Day 28) - Subjects (%) with PRO-2 subscore of 0-1 (Day 28) - Subjects (%) with improvement of PRO-2 subscore by =1 point (Day 28) - Subjects (%) with improvement of endoscopy subscore by =1 point (Day 28) - Subjects (%) with endoscopy subscore of 0-1 (Day 28) - Subjects (%) with clinical response of 0-1 (Day 28) - Change from baseline of faecal calprotectin compared to placebo (Day 28) - Change from baseline of serum C-reactive protein compared to placebo (Day 28) Pharmacokinetics - Pharmacokinetics (PK): Cmax in plasma (Time Frame: Day 1 and Day 14; Tmax in plasma [Time Frame: Day 1 and Day 14]; Area under curve (AUC) in plasma [Time Frame: Day 1 and Day 14]; Ctrough in plasma [ Time Frame: Day 1 and Day 14].;Timepoint(s) of evaluation of this end point: Efficacy: All parametres will be assessed Day 1 and Day 28. Pharmacokinetics: Cmax in plasma (Time Frame: Day 1 and Day 14; Tmax in plasma [Time Frame: Day 1 and Day 14]; Area under curve (AUC) in plasma [Time Frame: Day 1 and Day 14]; Ctrough in plasma [ Time Frame: Day 1 and Day 14]. | — |
Countries
Spain
Contacts
Public ContactGuido Kurz
ONCOSTELLAE S.L.
Outcome results
None listed