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    EudraCT Number:2018-003349-41
    Sponsor's Protocol Code Number:CYC-202
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-12-21
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2018-003349-41
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis
    A.4.1Sponsor's protocol code numberCYC-202
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSublimity Therapeutics (Hold Co) Ltd.
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDr. Falk Pharma GmbH
    B.4.1Name of organisation providing supportSublimity Therapeutics (Hold Co) Ltd.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSublimity Therapeutics
    B.5.2Functional name of contact pointAssociate Director
    B.5.3 Address:
    B.5.3.1Street AddressDCU Alpha Innovation Campus, Old Finglas Road
    B.5.3.2Town/ cityDublin
    B.5.3.3Post codeD11 KXN4
    B.5.4Telephone number1601 880 2826
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameST-0529
    D.3.2Product code FP-CYA-050
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCICLOSPORIN
    D.3.9.1CAS number 59865-13-3
    D.3.9.3Other descriptive namecyclosporine
    D.3.9.4EV Substance CodeSUB06250MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    Active inflammatory disease of large intestine or colon
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary efficacy objective is to evaluate the efficacy of ST-0529 in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.

    The safety objective is to evaluate the safety and tolerability of treatment with ST-0529 in subjects with moderately to severely active UC.
    E.2.2Secondary objectives of the trial
    To characterize the pharmacokinetics and pharmacodynamics of ST-0529 in subjects with UC.
    To determine the effect of treatment with ST-0529 on health-related Quality of Life in subjects with moderately to severely active UC.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A PK sub-study will be conducted in a subset of centers and subjects to develop a more detailed understanding of the whole blood PK of ST-0529 in UC subjects. Approximately 40 subjects are targeted to be enrolled into the PK sub-study, with whole blood samples being
    collected at Week 2 at 0 (pre-dose), and at 2, 4, 6, and 8 hours post-dose.

    The PK sub-study is an integral part of the main protocol
    E.3Principal inclusion criteria
    1. Male and female adult subjects 18 to 75 years old, inclusive.
    2. Diagnosis of UC established at least 3 months prior to the Baseline visit, by clinical and endoscopic evidence (colonoscopy or flexible sigmoidoscopy)
    3. 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.
    4. Evidence of active UC, confirmed histologically (from local read), extending proximal to the rectum with ≥ 15 cm of involved colon.
    5. 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
    6. 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 IV for up to 1 week or ≥ 9 mg/day oral budesonide;
    ii. Unable to reduce corticosteroids below the equivalent of prednisolone 10 mg
    daily orally within 3 months of starting steroids or experienced a relapse within 3 months of stopping steroids;
    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-MP ≥ 0.75 mg/kg);
    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, LFT abnormalities, lymphopenia, TPMT genetic mutation, infection).
    c. 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 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;
    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.
    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.
    7. 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.
    8. Subjects receiving oral 5-ASA must be on a stable dose from the initial Screening visit until the end of the study.
    E.4Principal exclusion criteria
    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 or radiation colitis.
    5. Subjects with evidence of pathogenic bowel infection (Clostridium difficile, Escheria 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. 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:
    a. Hemoglobin level < 8.0 g/dL
    b. Absolute WBC count < 3.0 × 10^9/L
    c. Absolute Lymphocyte count < 0.5 × 10^9/L
    d. Absolute neutrophil count < 1.2 × 10^9/L
    e. Platelet count < 100 × 10^9/L or >1200 × 10^9/L
    f. ALT or AST > 2.5 × ULN
    g. Alkaline phosphatase > 2.5 × ULN
    h. Serum creatinine > 1.5 × ULN
    i. Bilirubin > 1.5 × ULN
    9. Treatment with a biologic agent for UC within 56 days or 5 half-lives (whichever is greater) prior to the Baseline visit.
    10. Treatment with any calcineurin inhibitor (e.g. cyclosporine or tacrolimus) within 28 days prior to the Baseline visit.
    11. Treatment with methotrexate from the initial Screening visit until the end of the study.
    12. Initiation of treatment with an oral or IV corticosteroid from the initial Screening visit until the end of the study.
    13. Treatment with methotrexate or JAK inhibitors (e.g. tofacitinib) from the initial visit until the end of the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is clinical remission at Week 12, 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
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    • Clinical response at Week 12, 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.
    • Endoscopic healing (I) at Week 12 visit defined as endoscopic sub-score of ≤ 1.
    • Corticosteroid-free clinical response at Week 12 in subjects receiving corticosteroids at Baseline.
    • Corticosteroid-free clinical remission at Week 12 in subjects receiving corticosteroids at Baseline.
    • Changes from Baseline in individual Adapted Mayo sub-scores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    United States
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 190
    F.4.2.2In the whole clinical trial 380
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-28
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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