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Colitis, UlcerativePhase 2NCT03844932

A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis

A Phase 2 study testing ST-0529 in people with Colitis, Ulcerative, run by Sublimity Therapeutics Holdco Limited at 89 sites in 17 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Study CYC-202 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ST-0529 in subjects with moderately to severely active UC, defined as a score of 5 to 9 on the 3-Component Adapted Mayo Score (comprised of rectal bleeding, stool frequency and… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colitis, Ulcerative
What is being tested?
ST-0529
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
235 participants
Where
89 sitesin 17 countries
Study dates
24 Jan 2019to 14 Apr 2021
Phase
Phase 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

  • Male and female adult subjects 18 to 75 years old, inclusive.
  • Willing to provide written informed consent and to be compliant with the schedule of study visits and protocol assessments.
  • Diagnosis of UC established at least 3 months prior to the Baseline visit, by clinical and endoscopic evidence (colonoscopy or flexible sigmoidoscopy)
  • Moderately to severely active UC defined as the 3-Component Adapted Mayo Score of 5-9, inclusive, with an endoscopic sub-score of ≥ 2 (from central reading), and a rectal bleeding sub-score of ≥ 1, as determined 10 days (± 3 days) prior to Baseline.
  • Evidence of active UC, confirmed histologically (from local read), extending proximal to the rectum with ≥ 15 cm of involved colon.
  • At Screening, a colonoscopy will be required if the subject has had extensive colitis or pancolitis of > 8 years duration or left-sided colitis of > 12 years duration but has not had a colonoscopy within 1 year of the initial screening date. If the subject has had a colonoscopy within 1 year of the initial screening date, a flexible sigmoidoscopy may be used.
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  • Subjects presenting at Screening with moderately to severely active UC demonstrating an inadequate response or loss of response or intolerance/medical contraindication to at least one of the following conventional therapies for UC:
  • Corticosteroids:
  • Signs and symptoms of active disease despite treatment with an adequate dose (e.g., prednisolone > 40 mg/day or equivalent) over a period of 4 weeks for oral therapy or intravenously (IV) for up to 1 week or ≥ 9 mg/day oral budesonide;
  • OR
  • Unable to reduce corticosteroids below the equivalent of prednisolone 10 mg daily orally within 3 months of starting steroids or having experienced a relapse within 3 months of stopping steroids;
  • OR
  • History of, or current intolerance to corticosteroids (including, but not limited to Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection).
  • Immunomodulators:
  • Signs and symptoms of active disease despite at least 3 months of treatment with a sufficient dose (oral azathioprine ≥ 1.5 mg/kg or 6-mercaptopurine [6-MP] ≥ 0.75 mg/kg);
  • OR
  • History of, or current dose-limiting toxicity associated with use of the agent (e.g., but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test [LFT] abnormalities, lymphopenia, TPMT genetic mutation, infection).
  • Anti-tumor necrosis factor (anti-TNF) agents:
  • Signs and symptoms of active disease despite treatment with a single anti-TNF agent. Treatment failure is defined as a relapse after an initial response to therapy as follows:
  • Infliximab: At least 4 infusions of at least 5 mg/kg within a 14-week timeframe for induction and maintenance;
  • Adalimumab: Induction regimen incorporating 160 mg at Week 0 (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) and 80 mg at Week 2, followed by maintenance treatment of 40 mg every other week up to at least Week 8;
  • Golimumab: Induction regimen incorporating 200 mg subcutaneous (sc) injection at Week 0, followed by 100 mg at Week 2 and then maintenance treatment of 50 mg or 100 mg (weight dependent) every 4 weeks after completion of the induction regimen up to at least Week 12;
  • OR
  • History of, or current intolerance (with an initial response), defined as the presence of clinically significant side-effects, including infusion-related hypersensitivity.
  • Vedolizumab:
  • Signs and symptoms of active disease despite a history of at least one induction regimen, defined as at least a 14-week (10 weeks in the EU) induction consisting of 300 mg IV at Weeks 0, 2 and 6.
  • OR
  • History of intolerance to vedolizumab including, but not limited to, serious infections, hepatotoxicity, heart failure, allergic reactions, or any other condition that contributed to discontinuation of the agent.
  • Subjects receiving oral corticosteroids for the treatment of UC must be on a stable dose of ≤ 40 mg/day (prednisolone or equivalent), or ≤ 9 mg/day budesonide. This dose must be stable from the initial Screening visit until 1 week after the initiation of study treatment.
  • Subjects receiving oral 5-ASA must be on a stable dose from the initial Screening visit until the end of the study.
  • Subjects willing to cease the use of any therapeutic enema or suppository or foams, other than that required in preparation for study-mandated colonoscopy/flexible sigmoidoscopies, from the initial Screening visit until the end of the study.
  • Subjects willing to cease use of azathioprine or 6-MP from the initial Screening visit until the end of the study.
  • Negative serum pregnancy test in females of childbearing potential at Screening.
  • If female and of childbearing potential, must agree to be sexually abstinent or use one of the following highly effective methods of birth control from the initial Screening visit until 30 days after the last dose of study drug is administered:
  • Hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants);
  • Intrauterine contraceptive system;
  • Surgical sterilization or partner sterile (must have documented proof);
  • AND
  • One of the following effective methods of birth control:
  • Male/female condom;
  • Cervical cap with spermicide;
  • Diaphragm with spermicide;
  • Contraceptive sponge.
  • Male subjects must be either surgically sterile (must have documented proof), agree to be sexually inactive or use a double-barrier method of birth control (e.g., condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration until 90 days after final drug administration.

Who cannot join

  • If a subject has any of the following criteria, they will be excluded from the study:
  • Subjects without previous treatment for UC.
  • Ulcerative colitis limited to rectum (ulcerative proctitis).
  • Evidence of acute severe colitis with toxic megacolon, abdominal abscess, bowel stricture or bowel perforation.
  • A diagnosis of Crohn's colitis, colitis yet to be classified, ischemic colitis, NSAID-induced colitis, idiopathic colitis (i.e., colitis not consistent with UC) or radiation colitis.
  • Subjects with evidence of pathogenic bowel infection (Clostridium difficile, Escherichia coli, Salmonella, Shigella or Campylobacter).
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  • Previous surgery for UC or, in the opinion of the Investigator, will likely require surgery for UC during the study.
  • Any histological evidence of mucosal dysplasia.
  • Subjects with a current or recent history of severe, progressive or uncontrolled cardiac (including uncontrolled hypertension), renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological (e.g., history of seizures) disease, abnormal magnesium or potassium levels, hypocholesterolemia, or any other severe co-morbidity that, in the opinion of the Investigator, could confound the study results or put the study subject at unreasonable risk.
  • Malignancies or history of malignancy within 5 years of the initial Screening visit, with the exception of adequately treated or excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin.
  • Any of the following laboratory abnormalities during the screening period - if values are initially outside the prescribed limits, the evaluation may be repeated once within the screening period to determine eligibility:
  • Hemoglobin level < 8.0 g/dL
  • Absolute WBC count < 3.0 × 10^9/L
  • Absolute Lymphocyte count < 0.5 × 10^9/L
  • Absolute neutrophil count < 1.2 × 10^9/L
  • Platelet count < 100 × 10^9/L or >1200 × 10^9/L
  • ALT or AST > 2.0 × ULN
  • Alkaline phosphatase > 2.0 × ULN
  • Serum creatinine > 1.5 × ULN
  • Bilirubin > 1.5 × ULN
  • Subjects with active TB infection or known history of prior treated or untreated TB infection.
  • Subject with a positive serology test result for HIV (HIV type 1 or type 2).
  • Subject with a positive serology test result for active HBV or HCV infection.
  • Treatment with biologic agents for UC within 56 days or 5 half-lives (whichever is greater) prior to the Baseline visit.
  • Treatment with any calcineurin inhibitor (e.g. cyclosporine or tacrolimus) within 28 days prior to the Baseline visit.
  • Treatment with methotrexate or JAK inhibitors (e.g. tofacitinib) from the initial Screening visit until the end of the study.
  • Initiation of treatment with an oral or IV corticosteroid from the initial Screening visit until the end of the study.
  • Use of any strong inhibitors of CYP enzymes (e.g., cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, grapefruit juice and HIV antivirals) within 14 days prior to the Baseline visit.
  • Use of strong or moderate P-gp inhibitors (e.g., amiodarone, azithromycin, clarithromycin, itraconazole, ketoconazole, dronedarone, lapatinib, quinidine, ranolazine, verapamil) within 14 days prior to the Baseline visit.
  • Use of any herbal medication for the treatment of UC or which might interfere with CYP enzymes within 14 days prior to the Baseline visit.
  • Subjects vaccinated with a live or live-attenuated vaccine within 14 days of the Baseline visit, or planned vaccination during conduct of the study.
  • Subjects with a QTcF of > 450 ms for males and > 470 ms for females at Screening.
  • A history of risk factors for Torsades de pointes (e.g., history of heart failure, hypokalemia, family history of Long QT Syndrome).
  • Known hypersensitivity to cyclosporine or any excipients contained in ST-0529.
  • History of alcohol or drug abuse in the year prior to the initial Screening visit.
  • Subjects currently breast feeding, pregnant, or unwilling to delay initiation of breast feeding for at least 90 days after the last dose of study drug is administered.
  • Participation in another clinical trial and having received investigational medication within 30 days or within 5 half-lives (whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial.
  • Subjects who, in the opinion of the Investigator, are unsuitable for inclusion in the study.

Trial locations and contacts

89 sites in 17 countries.

89 sites in 17 countries

Ukraine14 sites

  • Chernivtsi Regional Clinical Hospital

    Chernivtsi, 58001

  • Ivano-Frankivsk National Medical University, Regional Clinical Hospital

    Ivano-Frankivsk, 76008

  • Kharkiv City Clinical Hospital No 2 n.a. prof. O.O.Shalimov

    Kharkiv, 61037

  • Kiev City Clinical Hospital No. 1

    Kiev, 2091

  • Communal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital"

    Kyiv, 04107

  • Ukrainian-German Gastroenterology Center "BYK-Kyiv"

    Kyiv, 1030

  • Volyn Regional Clinical Hospital

    Lutsk, 43000

  • Communal Nonprofit Enterprise "Lviv Clinical Emergency Care Hospital"

    Lviv, 79059

  • Communal Nonprofit Entreprise, "Lviv Clinical Emergency Care Hospital", 1st Therapeutic Dpt

    Lviv, 79059

  • Communal Nonprofit Enterprise "Odesa Regional Clinical Hospital"

    Odesa, 65025

  • Communal Nonprofit Enterprise "Ternopil University Hospital" of Ternopil Regional Council

    Ternopil, 46002

  • Municipal Institution "Uzhhorod Central District Hospital"

    Uzhhorod, 88009

  • Medical Center "Health Clinic"

    Vinnytsia, 21000

  • Communal Non-profit Enterprise "Vinnytsia City Clinical Hospital #1"

    Vinnytsia, 21029

Other trials in Ukraine

Russia10 sites

  • Federal State Center of Coloproctology

    Moscow, 123423

  • LLC Medical center Healthy family

    Novosibirsk, 630099

  • Military Medical Academy

    Saint Petersburg, 191 124

  • North-Western State Medical University n.a. I.I.Mechnikov

    Saint Petersburg, 191015

  • Saint-Petersburg State Medical Academy n.a. I.I. Mechnikov of Federal Agency of Healthcare & Social Development

    Saint Petersburg, 195067

  • Scientific Research Center Eco-Safety LLC

    Saint Petersburg, 196143

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, 197022

  • Non state Public Health Institution "Railway clinical hospital on station Samara" of joint stock company Russian railways

    Samara, 403029

  • Saratov State Medical University

    Saratov, 410054

  • Siberia State Medical University

    Tomsk, 630055

Other trials in Russia

Germany9 sites

  • Medizinische Klinik für Gastroenterologie, Infektiologie, Rheumatologie charite

    Berlin, 12203

  • Krankenhaus Walfriede, Akademisches Lehrkrankenhaus der Charite

    Berlin, 14163

  • Klinik für Gastroenterologie, Pulmologie und allg. lnnere Medizin

    Cologne, 5103

  • Agaplesion Markus Krankenhaus Medizinischen Klinik I, Gastroenterologie, Hepatologie, Onkologie, lnfektiologie

    Frankfurt, 60431

  • Universitatsklinikum Freiburg, Medizinische Klinik

    Freiburg im Breisgau, 79106

  • Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Zentrym für Innere Medizin

    Hanover, 30625

  • Eugastro GmbH

    Leipzig, Saxony, 4103

  • Universität Leipzig, Klinik f. Gastroenterologie und Rheumatologie

    Leipzig, 4103

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32123

Other trials in Germany

United States8 sites

  • University of Chicago

    Chicago, Illinois, 60637

  • AGA Clinical Reasearch Associates, LLC

    Egg Harbor, New Jersey, 08234

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Biopharma Informatic, LLC.

    Houston, Texas, 77084

  • Advanced Research Institute

    Largo, Florida, 33377

  • Advanced Research Institute, Inc.

    New Port Richey, Florida, 34653

  • Endoscopic Research Inc

    Orlando, Florida, 32803

  • Palmtree Clinical Research Inc

    Palm Springs, California, 92262

Other trials in United States

United Kingdom7 sites

  • Barnsley Hospital NHS Foundation Trust

    Barnsley, Yorkshire, S75 2EP

  • South Eastern Health & Social Care Trust, Ulster Hospital

    Belfast, Co Antrim, BT161RH

  • Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

    Birmingham, Warwickshire, B15 2TH

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

  • Royal Liverpool & Broadgreen University Hospitals NHS Trust

    Liverpool, Merseyside, L7 8XP

  • University College London Hospital NHS Foundation Trust

    London, NWI 2BU

  • King's College Hospital NHS Foundation Trust

    London, SE59RS

Other trials in United Kingdom

Poland6 sites

  • Centrum Opieki Zdrowotnej Orkan-med

    Ksawerów, 95-054

  • Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego UM

    Lodz, 90-153

  • Medicome Sp. z o.o.

    Oświęcim, 32600

  • Centrum Medyczne Medyk

    Rzeszów, 35-526

  • Endoskopia sp. z o.o.

    Sopot, 81-756

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

Other trials in Poland

Italy5 sites

  • Humanitas Research Hospital, IBD Center

    Milan, 20089

  • A.0.U. di Modena - Policlinico S.C. di Gastroenterologia

    Modena, 41124

  • Fondazione IRCCS Policlinico San Matteo - Medicina Generale I

    Pavia, 27100

  • ASST Rhodense - Ospedale di Rho

    Rho, 20017

  • Fondazione Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

Other trials in Italy

France4 sites

  • CHU Amiens Picardie - Service Hépato-Gastroentérologie

    Amiens, 80054

  • CHU DE MONTPELLIER - Hôpital St ELOI

    Montpellier, 34295

  • CHU de Saint-Etienne - Service de Gastro-Entérologie-Hépatologie

    Saint-Etienne, 42055

  • Hôpital de Brabois Service d'Hépato-Gastro-Entérologie

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Hungary4 sites

  • DRC Gyógyszervizsgáló Központ Kft.

    Balatonfüred, 8230

  • Semmelweis University

    Budapest, 1088

  • Semmelweis University, AOK Varosmajori Sziv- es Ergyogyaszati Klinika,

    Budapest, H-1031

  • Bugat Pal Hospital

    Gyöngyös, 3200

Other trials in Hungary

Israel4 sites

  • Gastroenterology Institute, Emek Medical Center

    Afula, 1834111

  • Barzilai Medical Center

    Ashkelon, 7830604

  • Clalit Health Services Jerusalem

    Jerusalem, 9362410

  • Institute of Gastroenterology, Meir Medical Center

    Kfar Saba, 4428164

Other trials in Israel

Serbia4 sites

  • Clinical Center Zvezdara

    Belgrade, 11000

  • Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"

    Belgrade, 11000

  • Clinical-Hospital Centre Bezanijska Kosa - Gastroenterology Department

    Belgrade, 11080

  • Clinical Center Kragujevac

    Kragujevac, 34000

Other trials in Serbia

Belarus3 sites

  • Grodno Regional Clinical Hospital

    Grodno, 230017

  • Gomel Regional Clinical Hospital

    Homyel, 246 029

  • City Clinical Emergency Hospital

    Minsk, 220024

Other trials in Belarus

Bulgaria3 sites

  • MedConsult Pleven

    Pleven, 5800

  • Medical Center Asklepion

    Sofia, 1303

  • UMBAL Tsaritsa Joanna ISUL

    Sofia, 1527

Other trials in Bulgaria

Romania3 sites

  • MedLife Grivita

    Bucharest, 010719

  • Colentina Clinical Hospital

    Bucharest, 020125

  • University Hospital Bucharest

    Bucharest, 050098

Other trials in Romania

Canada2 sites

  • Dalhousie University - Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

Other trials in Canada

Ireland2 sites

  • Mater Misericordiae University Hospital

    Dublin, D07 RX49

  • St. James's Hospital

    Dublin

Other trials in Ireland

Spain1 site

  • Hospital Universitario Virgen de la Macarena

    Seville, 41009

Other trials in Spain

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis

Study CYC-202 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ST-0529 in subjects with moderately to severely active UC, defined as a score of 5 to 9 on the 3-Component Adapted Mayo Score (comprised of rectal bleeding, stool frequency and endoscopy sub-scores; score range 0-9).

Read the detailed description

The study consists of a Screening period, Treatment period and Follow-up. The Screening period is comprised of two separate in-clinic visits, SV1 and SV2. At the initial Screening visit (SV1), subjects will be required to provide written informed consent to participate in the study and will then be assessed for eligibility. Electronic diaries will be provided to subjects at this visit to use for the duration of the study in order to record information relating to their UC disease. Subjects will return to the clinic for their Screening endoscopic assessment (SV2). Ulcerative colitis disease activity for eligibility will be assessed using the 3-Component Adapted Mayo Score. Upon successful completion of the Screening period, subjects will return to the clinic for their Baseline visit.

During the Treatment period, subjects will be evaluated in the clinic at Baseline (Day 1), Week 2, Week 4, Week 8, and Week 12 (End of Treatment Period). At Week 6 and Week 10, subjects will be contacted by telephone to assess Adverse Events (AEs), concomitant medication usage and study drug regimen adherence.

Subjects who complete the 12-week Treatment period will attend the Week 16 End of Study (EOS) visit. Subjects who discontinue study drug and withdraw or are withdrawn from the study before the Week 12 visit will be requested to return to the clinic as soon as possible to complete an Early Termination (ET) visit.

Being tested
ST-0529
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • ST-0529Drug

    Also called cyclosporine

    ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.

Study groups in NCT03844932
Study groupRoleWhat they receive
ST-0529 18.75 mg*ExperimentalST-0529: 18.75 mg orally twice daily (BID) *Jan 2021 update: following the IDMC recommendation, this arm has been dropped
Receives: Drug: ST-0529
ST-0529 37.5 mg*ExperimentalST-0529: 37.5 mg orally twice daily (BID) *Jan 2021 update: following the IDMC recommendation, this arm has been dropped
Receives: Drug: ST-0529
ST-0529 75 mgExperimentalST-0529: 75 mg orally twice daily (BID)
Receives: Drug: ST-0529
Matching PlaceboPlacebo comparatorPlacebo: matching placebo orally twice daily (BID)
Receives: Drug: ST-0529

What is being measured

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

  1. Clinical Remission at Week 12

    Stool frequency sub-score of ≤ 1 associated with a decrease ≥ 1 point from baseline, rectal bleeding sub-score of 0, and an endoscopic sub-score of ≤ 1 using the 3-Component Adapted Mayo Score.

    The 3-Component Adapted Mayo Score is a measure of UC disease ranging from 0 to 9 points and consists of 3 sub-scores, each graded from 0 - 3 with higher scores indicating more severe disease. The sub-scores are stool frequency (0 - 3); rectal bleeding (0 - 3); findings of endoscopy (0 - 3).

    Measured: Week 12

Secondary outcomes (5)

  1. Clinical Response at Week 12

    A decrease from baseline in the 3-Component Adapted Mayo Score of ≥ 2 points and ≥ 30%, with an accompanying decrease in the sub-score for rectal bleeding of ≥ 1 point or an absolute sub-score for rectal bleeding of ≤ 1.

    The 3-Component Adapted Mayo Score is a measure of UC disease ranging from 0 to 9 points and consists of 3 sub-scores, each graded from 0 - 3 with higher scores indicating more severe disease. The sub-scores are stool frequency (0 - 3); rectal bleeding (0 - 3); findings of endoscopy (0 - 3).

    Measured: Week 12

  2. Endoscopic Healing at Week 12

    Endoscopic Healing (I) defined as an endoscopic sub-score of ≤ 1.

    The endoscopic sub-score is part of the 3-Component Adapted Mayo score and ranges from 0 - 3, with higher scores indicating more severe disease.

    Measured: Week 12

  3. Corticosteroid-free clinical response at Week 12

    Clinical response and achieving a corticosteroid-free status at Week 12 in subjects using oral corticosteroids at the Baseline visit. Clinical response is defined as a decrease from baseline in the 3-Component Adapted Mayo Score of ≥ 2 points and > 30%, with an accompanying decrease in the sub-score for rectal bleeding of ≥ 1 point or an absolute sub-score for rectal bleeding of ≤ 1.

    Measured: Week 12

  4. Corticosteroid-free clinical remission at Week 12

    Clinical remission and achieving a corticosteroid-free status at Week 12 in subjects using oral corticosteroids at the Baseline visit. Clinical remission is defined as a stool frequency sub-score of ≤ 1 associated with a decrease ≥ 1 point from baseline, rectal bleeding sub-score of 0, and an endoscopic sub-score of ≤ 1 using the 3-Component Adapted Mayo Score.

    Measured: Week 12

  5. Changes from baseline in individual Adapted Mayo sub-scores at Week 12

    The Adapted Mayo Score is a measure of UC disease ranging from 0 to 12 points and consists of 4 sub-scores, each graded from 0 - 3 with higher scores indicating more severe disease. The sub-scores are stool frequency (0 - 3); rectal bleeding (0 - 3); findings of endoscopy (0 - 3); and Physician's Global Assessment [PGA] (0 - 3).

    Measured: Week 12

Timeline

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

  1. First posted19 Feb 2019
  2. Study start24 Jan 2019
  3. Primary completion14 Apr 2021
  4. Study completion14 Apr 2021

Why it stopped: The Sublimity Board of Directors carefully evaluated the IA data: the 9.6% treatment remission difference for 75mg BID vs placebo (due to an increase in placebo response rate) was determined not sufficient to continue to fund the study

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will investigate ST-0529 doses of 18.75 mg BID, 37.5 mg BID, or 75 mg BID, versus matching placebo BID.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03844932
Sponsor's protocol ID
CYC-202
Status last verified
May 2021
First submitted
31 Jan 2019
Last updated
7 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ST-0529 in people with Colitis, Ulcerative, run by Sublimity Therapeutics Holdco Limited at 89 sites in 17 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 44 inclusion and 38 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: stopped early, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in Ukraine, Russia, Germany, United States, United Kingdom and 12 more countries. 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 phase mean?

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 was stopped early (reason given: The Sublimity Board of Directors carefully evaluated the IA data: the 9.6% treatment remission difference for 75mg BID vs placebo (due to an increase in placebo response rate) was determined not sufficient to continue to fund the study). Results are not available in the source record.

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?

Clinical Remission at Week 12 (time frame: Week 12). 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 NCT03844932.

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 7 May 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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