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

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).

Study Overview

• Status: Terminated
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Drug: ST-0529

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 Subjects who discontinue study drug and withdraw or are withdrawn from the study before the Week 12 visit will be requested to return to the clinic as soon as possible to complete an Early Termination (ET) visit.

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belarus
  • Gomel, Belarus, 246 029
    • Gomel Regional Clinical Hospital
  • Grodno, Belarus, 230017
    • Grodno Regional Clinical Hospital
  • Minsk, Belarus, 220024
    • City Clinical Emergency Hospital
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Medconsult Pleven
  • Sofia, Bulgaria, 1303
    • Medical Center Asklepion
  • Sofia, Bulgaria, 1527
    • UMBAL Tsaritsa Joanna ISUL
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Dalhousie University - Queen Elizabeth II Health Sciences Centre
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
• France
  • Amiens, France, 80054
    • CHU Amiens Picardie - Service Hépato-Gastroentérologie
  • Montpellier, France, 34295
    • CHU DE MONTPELLIER - Hôpital St ELOI
  • Saint-Étienne, France, 42055
    • CHU de Saint-Etienne - Service de Gastro-Entérologie-Hépatologie
  • Vandœuvre-lès-Nancy, France, 54511
    • Hôpital de Brabois Service d'Hépato-Gastro-Entérologie
• Germany
  • Berlin, Germany, 12203
    • Medizinische Klinik für Gastroenterologie, Infektiologie, Rheumatologie charite
  • Berlin, Germany, 14163
    • Krankenhaus Walfriede, Akademisches Lehrkrankenhaus der Charite
  • Frankfurt, Germany, 60431
    • Agaplesion Markus Krankenhaus Medizinischen Klinik I, Gastroenterologie, Hepatologie, Onkologie, lnfektiologie
  • Freiburg, Germany, 79106
    • Universitatsklinikum Freiburg, Medizinische Klinik
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Zentrym für Innere Medizin
  • Köln, Germany, 5103
    • Klinik für Gastroenterologie, Pulmologie und allg. lnnere Medizin
  • Leipzig, Germany, 4103
    • Universität Leipzig, Klinik f. Gastroenterologie und Rheumatologie
  • Minden, Germany, 32123
    • Gastroenterologische Gemeinschaftspraxis Minden
  • Saxony
    • Leipzig, Saxony, Germany, 4103
      • Eugastro GmbH
• Hungary
  • Balatonfüred, Hungary, 8230
    • DRC Gyogyszervizsgalo Kozpont Kft.
  • Budapest, Hungary, 1088
    • Semmelweis University
  • Budapest, Hungary, H-1031
    • Semmelweis University, AOK Varosmajori Sziv- es Ergyogyaszati Klinika,
  • Gyongyos, Hungary, 3200
    • Bugat Pal Hospital
• Ireland
  • Dublin, Ireland
    • St. James's Hospital
  • Dublin, Ireland, D07 RX49
    • Mater Misericordiae University Hospital
• Israel
  • Afula, Israel, 1834111
    • Gastroenterology Institute, Emek Medical Center
  • Ashkelon, Israel, 7830604
    • Barzilai Medical Center
  • Jerusalem, Israel, 9362410
    • Clalit Health Services Jerusalem
  • Kfar Saba, Israel, 4428164
    • Institute of Gastroenterology, Meir Medical Center
• Italy
  • Milan, Italy, 20089
    • Humanitas Research Hospital, IBD Center
  • Modena, Italy, 41124
    • A.0.U. di Modena - Policlinico S.C. di Gastroenterologia
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo - Medicina Generale I
  • Rho, Italy, 20017
    • Asst Rhodense - Ospedale Di Rho
  • San Giovanni Rotondo, Italy, 71013
    • Fondazione Casa Sollievo della Sofferenza
• Poland
  • Ksawerów, Poland, 95-054
    • Centrum Opieki Zdrowotnej Orkan-med
  • Oświęcim, Poland, 32600
    • Medicome Sp. z o.o.
  • Rzeszów, Poland, 35-526
    • Centrum Medyczne Medyk
  • Sopot, Poland, 81-756
    • Endoskopia Sp. z o.o.
  • Warszawa, Poland, 00-728
    • WIP Warsaw IBD Point Profesor Kierkus
  • Łódź, Poland, 90-153
    • Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego UM
• Romania
  • Bucharest, Romania, 020125
    • Colentina Clinical Hospital
  • Bucharest, Romania, 010719
    • MedLife Grivita
  • Bucharest, Romania, 050098
    • University Hospital Bucharest
• Russian Federation
  • Moscow, Russian Federation, 123423
    • Federal State Center of Coloproctology
  • Novosibirsk, Russian Federation, 630099
    • LLC Medical center Healthy family
  • Saint Petersburg, Russian Federation, 197022
    • Pavlov First Saint Petersburg State Medical University
  • Saint Petersburg, Russian Federation, 196143
    • Scientific Research Center Eco-Safety LLC
  • Saint Petersburg, Russian Federation, 191 124
    • Military Medical Academy
  • Saint Petersburg, Russian Federation, 191015
    • North-Western State Medical University n.a. I.I.Mechnikov
  • Saint-Petersburg, Russian Federation, 195067
    • Saint-Petersburg State Medical Academy n.a. I.I. Mechnikov of Federal Agency of Healthcare & Social Development
  • Samara, Russian Federation, 403029
    • Non state Public Health Institution "Railway clinical hospital on station Samara" of joint stock company Russian railways
  • Saratov, Russian Federation, 410054
    • Saratov State Medical University
  • Tomsk, Russian Federation, 630055
    • Siberia State Medical University
• Serbia
  • Belgrad, Serbia, 11000
    • Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"
  • Belgrade, Serbia, 11000
    • Clinical Center Zvezdara
  • Belgrade, Serbia, 11080
    • Clinical-Hospital Centre Bezanijska Kosa - Gastroenterology Department
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
• Spain
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen De La Macarena
• Ukraine
  • Chernivtsi, Ukraine, 58001
    • Chernivtsi Regional Clinical Hospital
  • Ivano-Frankivsk, Ukraine, 76008
    • Ivano-Frankivsk National Medical University, Regional Clinical Hospital
  • Kharkiv, Ukraine, 61037
    • Kharkiv City Clinical Hospital No 2 n.a. prof. O.O.Shalimov
  • Kiev, Ukraine, 2091
    • Kiev City Clinical Hospital No. 1
  • Kyiv, Ukraine, 04107
    • Communal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital"
  • Kyiv, Ukraine, 1030
    • Ukrainian-German Gastroenterology Center "BYK-Kyiv"
  • Lutsk, Ukraine, 43000
    • Volyn Regional Clinical Hospital
  • Lviv, Ukraine, 79059
    • Communal Nonprofit Enterprise "Lviv Clinical Emergency Care Hospital"
  • Lviv, Ukraine, 79059
    • Communal Nonprofit Entreprise, "Lviv Clinical Emergency Care Hospital", 1st Therapeutic Dpt
  • Odesa, Ukraine, 65025
    • Communal Nonprofit Enterprise "Odesa Regional Clinical Hospital"
  • Ternopil, Ukraine, 46002
    • Communal Nonprofit Enterprise "Ternopil University Hospital" of Ternopil Regional Council
  • Uzhhorod, Ukraine, 88009
    • Municipal Institution "Uzhhorod Central District Hospital"
  • Vinnytsia, Ukraine, 21000
    • Medical Center "Health Clinic"
  • Vinnytsia, Ukraine, 21029
    • Communal Non-profit Enterprise "Vinnytsia City Clinical Hospital #1"
• United Kingdom
  • London, United Kingdom, NWI 2BU
    • University College London Hospital NHS Foundation Trust
  • London, United Kingdom, SE59RS
    • King's College Hospital NHS Foundation Trust
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Addenbrooke's Hospital
  • Co Antrim
    • Belfast, Co Antrim, United Kingdom, BT161RH
      • South Eastern Health & Social Care Trust, Ulster Hospital
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L7 8XP
      • Royal Liverpool & Broadgreen University Hospitals NHS Trust
  • Warwickshire
    • Birmingham, Warwickshire, United Kingdom, B15 2TH
      • Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
  • Yorkshire
    • Barnsley, Yorkshire, United Kingdom, S75 2EP
      • Barnsley Hospital NHS Foundation Trust
• United States
  • California
    • Palm Springs, California, United States, 92262
      • Palmtree Clinical Research Inc
  • Florida
    • Largo, Florida, United States, 33377
      • Advanced Research Institute
    • New Port Richey, Florida, United States, 34653
      • Advanced Research Institute, Inc.
    • Orlando, Florida, United States, 32803
      • Endoscopic Research Inc
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • New Jersey
    • Egg Harbor Township, New Jersey, United States, 08234
      • AGA Clinical Reasearch Associates, LLC
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77084
      • Biopharma Informatic, LLC.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female adult subjects 18 to 75 years old, inclusive.
2. Willing to provide written informed consent and to be compliant with the schedule of study visits and protocol assessments.
3. Diagnosis of UC established at least 3 months prior to the Baseline visit, by clinical and endoscopic evidence (colonoscopy or flexible sigmoidoscopy)
4. 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.
5. Evidence of active UC, confirmed histologically (from local read), extending proximal to the rectum with ≥ 15 cm of involved colon.
6. 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.

7. 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:

   a. Corticosteroids:

   i. 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

   ii. 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

   iii. History of, or current intolerance to corticosteroids (including, but not limited to Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection).

   b. Immunomodulators:

   i. 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

   ii. 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).

   c. Anti-tumor necrosis factor (anti-TNF) agents:

   i. 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

   ii. History of, or current intolerance (with an initial response), defined as the presence of clinically significant side-effects, including infusion-related hypersensitivity.

   d. Vedolizumab:

   i. 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

   ii. 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.

8. 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.
9. Subjects receiving oral 5-ASA must be on a stable dose from the initial Screening visit until the end of the study.
10. 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.
11. Subjects willing to cease use of azathioprine or 6-MP from the initial Screening visit until the end of the study.
12. Negative serum pregnancy test in females of childbearing potential at Screening.

13. 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:

    1. Hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants);
    2. Intrauterine contraceptive system;
    3. Surgical sterilization or partner sterile (must have documented proof);

    AND

    One of the following effective methods of birth control:

    1. Male/female condom;
    2. Cervical cap with spermicide;
    3. Diaphragm with spermicide;
    4. Contraceptive sponge.
14. 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.

Exclusion Criteria:

If a subject has any of the following criteria, they will be excluded from the study:

1. Subjects without previous treatment for UC.
2. Ulcerative colitis limited to rectum (ulcerative proctitis).
3. Evidence of acute severe colitis with toxic megacolon, abdominal abscess, bowel stricture or bowel perforation.
4. 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.
5. Subjects with evidence of pathogenic bowel infection (Clostridium difficile, Escherichia coli, Salmonella, Shigella or Campylobacter).
6. Previous surgery for UC or, in the opinion of the Investigator, will likely require surgery for UC during the study.
7. Any histological evidence of mucosal dysplasia.
8. 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.
9. 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.

10. 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:

    1. Hemoglobin level < 8.0 g/dL
    2. Absolute WBC count < 3.0 × 10^9/L
    3. Absolute Lymphocyte count < 0.5 × 10^9/L
    4. Absolute neutrophil count < 1.2 × 10^9/L
    5. Platelet count < 100 × 10^9/L or >1200 × 10^9/L
    6. ALT or AST > 2.0 × ULN
    7. Alkaline phosphatase > 2.0 × ULN
    8. Serum creatinine > 1.5 × ULN
    9. Bilirubin > 1.5 × ULN
11. Subjects with active TB infection or known history of prior treated or untreated TB infection.
12. Subject with a positive serology test result for HIV (HIV type 1 or type 2).
13. Subject with a positive serology test result for active HBV or HCV infection.
14. Treatment with biologic agents for UC within 56 days or 5 half-lives (whichever is greater) prior to the Baseline visit.
15. Treatment with any calcineurin inhibitor (e.g. cyclosporine or tacrolimus) within 28 days prior to the Baseline visit.
16. Treatment with methotrexate or JAK inhibitors (e.g. tofacitinib) from the initial Screening visit until the end of the study.
17. Initiation of treatment with an oral or IV corticosteroid from the initial Screening visit until the end of the study.
18. 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.
19. 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.
20. 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.
21. Subjects vaccinated with a live or live-attenuated vaccine within 14 days of the Baseline visit, or planned vaccination during conduct of the study.
22. Subjects with a QTcF of > 450 ms for males and > 470 ms for females at Screening.
23. A history of risk factors for Torsades de pointes (e.g., history of heart failure, hypokalemia, family history of Long QT Syndrome).
24. Known hypersensitivity to cyclosporine or any excipients contained in ST-0529.
25. History of alcohol or drug abuse in the year prior to the initial Screening visit.
26. 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.
27. 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.
28. Subjects who, in the opinion of the Investigator, are unsuitable for inclusion in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ST-0529 18.75 mg*; ST-0529: 18.75 mg orally twice daily (BID) *Jan 2021 update: following the IDMC recommendation, this arm has been dropped	Drug: ST-0529; ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.; Other Names: cyclosporine
Experimental: ST-0529 37.5 mg*; ST-0529: 37.5 mg orally twice daily (BID) *Jan 2021 update: following the IDMC recommendation, this arm has been dropped	Drug: ST-0529; ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.; Other Names: cyclosporine
Experimental: ST-0529 75 mg; ST-0529: 75 mg orally twice daily (BID)	Drug: ST-0529; ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.; Other Names: cyclosporine
Placebo Comparator: Matching Placebo; Placebo: matching placebo orally twice daily (BID)	Drug: ST-0529; ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.; Other Names: cyclosporine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 12
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.	Week 12
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.	Week 12
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.	Week 12
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).	Week 12

Collaborators and Investigators

• Sponsor: Sublimity Therapeutics Holdco Limited
• Collaborators: Dr. Falk Pharma GmbH
• Investigators: Study Director: Sponsor Responsible Medical Officer, Sublimity Therapeutics (HoldCo) Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Actual): April 14, 2021
• Study Completion (Actual): April 14, 2021

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Cyclosporine; Cyclosporins
• Other Study ID Numbers: CYC-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No