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    EudraCT Number:2016-000518-31
    Sponsor's Protocol Code Number:LYC-30937-2001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-19
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-000518-31
    A.3Full title of the trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A.4.1Sponsor's protocol code numberLYC-30937-2001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02762500
    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 SponsorLycera Corp.
    B.1.3.4CountryUnited States
    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 supportLycera Corp.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLycera Corp.
    B.5.2Functional name of contact pointLycera Clinical Department
    B.5.3 Address:
    B.5.3.1Street Address620 W. Germantown Pike, Suite 400
    B.5.3.2Town/ cityPlymouth Meeting
    B.5.3.3Post codePA 19462
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016104575095
    B.5.5Fax number0017342073178
    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.3.2Product code LYC-30937-EC
    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 INNLYC-30937
    D.3.9.1CAS number 1796641-10-5
    D.3.9.2Current sponsor codeLYC-30937
    D.3.9.3Other descriptive nameLYC-30937
    D.3.9.4EV Substance CodeSUB168579
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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 objective will be to assess the efficacy of LYC-30937-EC in inducing remission compared with placebo in subjects with active UC over a treatment duration of 8 weeks.
    E.2.2Secondary objectives of the trial
    The secondary objectives will be to evaluate the safety, tolerability, plasma tissue PK of LYC-30937-EC compared with placebo in subjects with 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
    Two pharmacokinetic sub studies will be part of the research: the safety pharmacokinetic substudy and the serial pharmacokinetic substudy. If patients agree to participate in one of these studies, extra blood will be taken to 1) determine plasma concentrations of LYC-30937, and 2) assess plasma PK parameters of LYC-30937 and its metabolite.
    E.3Principal inclusion criteria
    1. Consenting adults aged 18–75 years.
    2. Have had UC diagnosed at least 6 months prior to screening and with a minimum disease extent of ≥ 15 cm from the anal verge. The diagnosis of UC must be confirmed by endoscopic and histologic evidence (histology may be confirmed at screening based on biopsy collection during the screening colonoscopy with histological evaluation done by the site).
    3. Have active UC defined as a TMS of 4–11 (inclusive) with endoscopic subscore of ≥ 2 and rectal bleeding subscore of ≥ 1 at screening.
    4. Male and females subjects of childbearing potential must agree to use adequate birth control measures during the study. Female subjects of child bearing potential must use two highly effective forms of contraception, unless surgically sterilized, partner has had a vasectomy, or they will be abstinent, during study participation and for 30 days after their last dose of study drug. Highly effective methods of birth control in this study include: intrauterine device, hormonal contraceptives (oral patch, long acting injectable, implant), double-barrier method (condom or diaphragm with spermicide), or abstinence during study participation and for 30 days after their last dose of study drug. (Post-menopausal defined as lack of menses for ≥ 6 months prior to screening confirmed with serum FSH > 25 mIU/mL at screening.)
    5. If currently receiving any of the following UC treatments the duration and dose prior to the screening endoscopy must be as specified below and a stable dose should be maintained throughout the double-blind trial:
    a. Oral aminosalicylates (eg, mesalamine, sulfasalazine, olsalazine, balsalazide) for
    ≥ 6 weeks with the dose stable for ≥ 3 weeks prior to the Screening endoscopy (eg, if recently tapered off corticosteroid).
    b. Prednisone (dose ≤ 20 mg daily) or equivalent for ≥ 4 weeks and receiving a stable dose for ≥ 2 weeks prior to the screening endoscopy.
    c. Thiopurines (azathioprine or 6-mercaptopurine) provided the dose has been stable for ≥ 8 weeks prior to the screening endoscopy.
    6. If oral aminosalicylates (ASA) or corticosteroids have been recently discontinued, they must have been stopped for ≥ 2 weeks prior to the screening endoscopy (eg, if recently tapered off corticosteroid). If a thiopurine has recently been discontinued it must have been stopped ≥ 4 weeks prior to the screening endoscopy.
    7. Ability to provide written informed consent and to be compliant with the schedule of events.
    E.4Principal exclusion criteria
    1. Known mitochondrial disorder.
    2. History of CD or indeterminate colitis or the presence or history of a fistula consistent with CD.
    3. History of bleeding disorders (eg, complement disorders, hemophilia, history of uncontrolled bleeding).
    4. Severe extensive disease that in physician judgment the subject is likely to require colonic surgery during the 8 week double-blind course (eg, fulminant colitis, toxic megacolon, bowel perforation, evidence of an acute abdomen).
    5. Positive test for Clostridium (C.) difficile, positive stool culture for enteric pathogens (eg, Salmonella, Shigella, Campylobacter), or presence of ova or parasites at screening.
    Note that C. difficile may be treated and the subject may be retested for screening after
    he/she completed this treatment.
    6. Any of the following laboratory abnormalities:
    a. liver function tests > 1.5 x the upper limit of normal (ULN) or direct bilirubin > 1.5 x ULN.
    b. hemoglobin < 8.5 g/dl (international system units [SI]: < 85 g/L).
    c. neutrophils < 1500/mm3 (SI: < 1.5 x 109/L).
    d. white blood cell (WBC) count < 3,000/mm3 (SI: < 3.0 x 109/L).
    e. Platelets < 80,000 mm3 (SI: 80 x 109/L).
    f. international normalized ratio (INR) > 1.5.
    g. serum creatinine > 1.4 mg/dL for women or > 1.6 mg/dL for men.
    7. Treatment with non-thiopurine immunosuppressant agents within 4 weeks prior to screening endoscopy (eg, cyclosporine, methotrexate, tacrolimus, sirolimus, or mycophenolate mofetil) [MMF]
    8. Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (hCG) at
    screening. Female subjects should not be planning to become pregnant while enrolled in the trial.
    9. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, gastrointestinal, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study.
    10. History of uveitis within the 12 months prior to initiation of screening procedures.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects who achieve a clinical remission at Week 8 using the modified Mayo score (MMS). Clinical remission is defined as Mayo stool frequency subscore of ≤1, Mayo rectal bleeding subscore of 0 and Mayo endoscopy subscore of ≤1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 8 of participation of a subject.
    E.5.2Secondary end point(s)
    • The proportion of subjects who achieve clinical remission at Week 8 using the total Mayo score (TMS), defined as a Mayo score of ≤2, with no individual score >1, and rectal bleeding score of 0;
    • The proportion of subjects with a clinical response at Week 8, defined as a reduction from Baseline MMS of ≥2 points and ≥25%, and a decrease from baseline in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1 point;
    • The proportion of subjects with a clinical response at Week 8, defined as a reduction from Baseline in TMS of ≥3 points and ≥30%, and a decrease from Baseline in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1 point;
    • The change from baseline TMS at Week 8;
    • The change from baseline to Week 8 in fecal calprotectin.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 8 of participation of a patient.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 concerned26
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Czech Republic
    United States
    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
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 80
    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 state85
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 120
    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)
    Patients will be able to enroll into an open label follow up study.
    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 Decision2016-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-26
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