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Ulcerative Colitis Chronic ModeratePhase 1/2NCT04353791

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

A Phase 1/2 study testing OST-122 in people with Ulcerative Colitis Chronic Moderate and Ulcerative Colitis Chronic Severe, run by Oncostellae S.L at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
OST-122
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
16 sitesin 2 countries
Study dates
16 Sep 2020to 27 Dec 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • Has fulminant colitis, toxic megacolon, primary sclerosing cholangitis, Crohn's disease, history of moderate to severe colitis-associated colonic dysplasia, active peptic ulcer disease;
  • Medications of exclusion:
  • 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
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  • 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;
  • Use of products, food supplements or medical devices, whose composition includes probiotics in the 1 month prior to Baseline visit;
  • Patient who has prior extensive colonic resection, subtotal or total colectomy or planned surgery for ulcerative colitis;
  • Patient who has past or present fistula or abdominal abscess;
  • Patient who is pregnant or lactating;
  • Inability to comply with study protocol, in opinion of the investigator;
  • History of alcohol, drug or chemical abuse within 6 months prior to Screening visit;
  • 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.

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

Spain14 sites

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital Reina Sofía

    Córdoba

  • Hospital Universitari Doctor Josep Trueta

    Girona, 17007

  • Hospital San Jorge

    Huesca

  • Hospital Infanta Leonor

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Central de Asturias

    Oviedo

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, A Coruña

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Álvaro Cunqueiro

    Vigo, Pontevedra

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza

  • Hospital Universitario Miguel Servet

    Zaragoza

Other trials in Spain

Ukraine2 sites

  • Medical and Diagnostic Center PE PMC "Acinus"

    Kropyvnytskyi

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

    Kyiv

Other trials in Ukraine

About this study

Official title: 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

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.

Read the 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.

Being tested
OST-122, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OST-122Drug

    Active dose

  • PlaceboDrug

    Placebo

Study groups in NCT04353791
Study groupRoleWhat they receive
Experimental arm OST-122Active comparator24 subjects will be randomized to receive OST-122 orally daily for 28 days
Receives: Drug: OST-122
Control arm PlaceboPlacebo comparator8 subjects will be randomized to receive placebo orally daily for 28 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From baseline to end of the follow-up period

Secondary outcomes (8)

  1. Cmax: Maximum plasma concentration for OST-122

    Pharmacokinetic analysis of OST-122 peak concentration in plasma (ng/ml) in every subject enrolled in this trial

    Measured: Day 1 and Day 28

  2. Ctrough: Minimum plasma concentration for OST-122

    Pharmacokinetic analysis of OST-122 minimum concentration in plasma (ng/ml) in every subject enrolled in this trial

    Measured: Day 1 and Day 28

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

    Pharmacokinetic analysis of OST-122 time (in hours) needed for OST-122 to reach the Cmax (peak concentration) in every subject enrolled in this trial

    Measured: Day 1 and Day 28

  4. AUC: Area under the plasma-concentration time-curve

    Pharmacokinetic analysis of OST-122 observed area under the plasma-concentration time-curve (ng · h / ml) in every subject enrolled in this trial

    Measured: Day 1 and Day 28

  5. Percentage of subjects with improvement in Endoscopic Mayo Score

    Study the effect of OST-122 or placebo in Endoscopic Mayo Score

    Subjects (%) with improvement of endoscopy subscore by ≥1 point Subjects (%) with endoscopy subscore of 0-1

    Measured: Day 0 and Day 28

  6. Percentage of subjects with improvement in PRO-2

    Study the effect of OST-122 or placebo in PRO-2 [PRO-2: sum of the scores obtained in rectal bleeding and stool frequency (subscores 1+2 of the Mayo Score)]

    Subjects (%) with PRO-2 subscore of 0-1 Subjects (%) with improvement of PRO-2 subscore by ≥1 point Subjects (%) with improvement of rectal bleeding subscore by ≥1 point Subjects (%) with rectal bleeding subscore of 0-1 Subjects (%) with improvement of stool frequency subscore by ≥1 point Subjects (%) with stool frequency subscore of 0-1

    Measured: Day 0, Day 7, Day 14, Day 21, Day 28

  7. Study the effect of OST-122 or placebo on faecal calprotectin levels

    Change from baseline of faecal calprotectin (mg/kg) compared to placebo

    Measured: Day 1, Day 7, Day 14, Day 21, Day 28

  8. Effect of OST-122 or placebo on serum C-reactive protein levels

    Change from baseline of serum C-reactive protein (mg/L) compared to placebo

    Measured: Day 0, Day 14, Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2020
  2. Study start16 Sep 2020
  3. Primary completion27 Dec 2022
  4. Study completion27 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04353791
Sponsor's protocol ID
CT-OST-122-02
Status last verified
Jan 2022
First submitted
24 Mar 2020
Last updated
13 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OST-122 in people with Ulcerative Colitis Chronic Moderate and Ulcerative Colitis Chronic Severe, run by Oncostellae S.L at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Spain, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: From baseline to end of the follow-up period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04353791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.

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