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

NCT04353791 | Completed Phase 1 DMC

• 1 other identifier: CT-OST-122-02
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 16

Brief 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.

Conditions

Ulcerative Colitis Chronic Moderate; Ulcerative Colitis Chronic Severe

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety of OST-122 administered for 28 days in subjects with active UC by assessing the number, severity, and type of adverse events

  Number and severity of AEs reported including Clinically Significant Changes in vital signs, physical examination, Laboratory Measurements, and ECGs.

  From baseline to end of the follow-up period

Secondary Outcomes (8)

• Cmax: Maximum plasma concentration for OST-122

  Day 1 and Day 28

• Ctrough: Minimum plasma concentration for OST-122

  Day 1 and Day 28

• Tmax: Time to reach maximum plasma concentration (Cmax) for OST-122

  Day 1 and Day 28

• AUC: Area under the plasma-concentration time-curve

  Day 1 and Day 28

• Percentage of subjects with improvement in Endoscopic Mayo Score

  Day 0 and Day 28

Study Arms (2)

Experimental arm OST-122

ACTIVE COMPARATOR

24 subjects will be randomized to receive OST-122 orally daily for 28 days

Drug: OST-122

Control arm Placebo

PLACEBO COMPARATOR

8 subjects will be randomized to receive placebo orally daily for 28 days

Drug: Placebo

Interventions

OST-122 DRUG

Active dose

Experimental arm OST-122

Placebo DRUG

Placebo

Control arm Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent and capable of understanding and complying with the protocol;
• Patients male and female ≥ 18 and ≤ 75 years at the time of consent;
• 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;
• 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;
• 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;
• 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;
• Has an endoscopic Mayo subscore of ≥ 2 and a total Mayo score of 5-10 during screening;
• 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;
• 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;
• 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.

You may not qualify if:

• Has fulminant colitis, toxic megacolon, primary sclerosing cholangitis, Crohn's disease, history of moderate to severe colitis-associated colonic dysplasia, active peptic ulcer disease;
• Topical mesalazine or steroids (i.e., enemas or suppositories) within the 7 days prior to Baseline visit
• Azathioprine, 6-mercaptopurine, or methotrexate within 10 days prior to Baseline visit
• Intravenous corticosteroids within the 14 days prior to Baseline visit
• Tofacitinib or any other JAK inhibitor within 14 days prior to Baseline visit
• Anti-diarrheal treatment within 14 days prior to Baseline visit
• Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 14 days prior to Baseline visit
• Adalimumab within the 14 days prior to Baseline visit
• Infliximab, golimumab, etanercept, vedolizumab, ustekinumab or certolizumab within the 14 days prior to Baseline visit
• NSAIDs on a daily basis from 7 days previous to Baseline visit. Low doses, without anti-inflammatory effect, to treat or prevent other diseases i.e.: ictus, cerebrovascular or cardiovascular diseases, among others; are permitted.
• Has a current bacterial, parasitic, fungal, or viral infection;
• Is positive for hepatitis A, B or C, HIV (Human Immunodeficiency Virus) or tuberculosis, as assessed by method available at each site;
• 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;
• 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);
• 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;

Sponsors & Collaborators

• Oncostellae S.L: lead

Study Sites (16)

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Reina Sofía

Córdoba, Spain

Location

Hospital Universitari Doctor Josep Trueta

Girona, 17007, Spain

Location

Hospital San Jorge

Huesca, Spain

Location

Hospital Infanta Leonor

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

Medical and Diagnostic Center PE PMC "Acinus"

Kropyvnytskyi, Ukraine

Location

Medical Center "Ok!Clinic" of International Institute of Clinical Research LLC

Kyiv, Ukraine

Location

Study Officials

• Ascensión Heredia Rodríguez, PhD

  Oncostellae S.L

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: April 20, 2020
• Study Start: September 16, 2020
• Primary Completion: December 27, 2022
• Study Completion: December 27, 2022
• Last Updated: January 13, 2023

Record last verified: 2022-01

Locations

UA (2); ES (14)