Overview

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

Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Oncostellae S.L
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)-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;

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:

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 60 days prior to Baseline visit;

5. Anti-diarrheal treatment within14 days prior to Baseline visit.

6. Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within
30 days prior to Baseline visit.

7. Adalimumab within the 30 days prior to Baseline visit

8. Infliximab, golimumab, etanercept, vedolizumab, ustekinumab or certolizumab
within the 60 days prior to Baseline visit

9. 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, with the exception of those patients who after a careful evaluation,
the PI considers they may obtain a clinical benefit from the therapy.

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.