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    EudraCT Number:2020-001398-59
    Sponsor's Protocol Code Number:OSE-127-C201
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-07
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedCroatia - MIZ
    A.2EudraCT number2020-001398-59
    A.3Full title of the trial
    Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s)
    Randomizirano, dvostruko slijepo ispitivanje faze 2 za procjenu učinkovitosti i sigurnosti lijeka OSE 127 u odnosu na placebo u ispitanika s umjerenim do teškim oblikom aktivnog ulceroznog kolitisa koji su neuspješno liječeni ili nisu podnosili prethodna liječenja
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)
    Kliničko ispitivanje za procjenu učinkovitosti i sigurnosti lijeka OSE 127 u odnosu na placebo u ispitanika s ulceroznim kolitisom koji su neuspješno liječeni ili nisu podnosili prethodna liječenja.
    A.4.1Sponsor's protocol code numberOSE-127-C201
    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 SponsorOSE Immunotherapeutics
    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 supportOSE Immunotherapeutics
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOSE Immunotherapeutics
    B.5.2Functional name of contact pointOSE Contact
    B.5.3 Address:
    B.5.3.1Street Address22 boulevard Benoni Goullin
    B.5.3.2Town/ cityNantes
    B.5.3.3Post code44200
    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 nameOSE-127
    D.3.2Product code OSE-127
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLusvertikimab
    D.3.9.1CAS number 2375835-91-7
    D.3.9.2Current sponsor codeOSE-127
    D.3.9.3Other descriptive namehumanized recombinant IgG4 monoclonal antibody against CD-127
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe Ulcerative Colitis
    Umjereni do teški oblik ulceroznog kolitisa
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis which is a type of inflammatory bowel disease
    Ulcerozni kolitis koji je vrsta upalne bolesti crijeva
    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
    To assess the efficacy of OSE-127 versus placebo on the reduction of the modified Mayo Score in moderate-to-severe UC patients who have previously failed or lost response or are intolerant to previous treatment(s)
    Procijeniti učinkovitost lijeka OSE 127 naspram placeba u smanjenju modificiranog Mayo indeksa u bolesnika s umjerenim do teškim oblikom ulceroznog kolitisa koji su prethodno neuspješno liječeni ili su izgubili terapijski odgovor ili nisu podnosili prethodna liječenja.
    E.2.2Secondary objectives of the trial
    _ To assess the efficacy of OSE-127 versus placebo on the rate of clinical remission
    _ To assess the clinical efficacy of OSE-127 versus placebo on the rate of clinical response
    _ To assess the efficacy of OSE-127 versus placebo on endoscopic remission and on endoscopic improvement
    _ To assess the overall safety and tolerability of OSE-127 in patients with moderate to severe UC
    _Procijeniti učinkovitost lijeka OSE 127 naspram placeba u odnosu na stopu kliničke remisije.
    _Procijeniti kliničku učinkovitost lijeka OSE 127 naspram placeba u odnosu na stopu kliničkog odgovora.
    _Procijeniti učinkovitost lijeka OSE 127 naspram placeba na temeljuendoskopski utvrđene remisije i endoskopski utvrđenog poboljšanja.
    _Procijeniti sveukupnu sigurnost primjene i podnošljivost lijeka OSE127 naspram placeba u bolesnika s umjerenim do teškim oblikom ulceroznog kolitisa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment
    2. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
    3. Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose
    4. Male or female 18 to 75 years of age, inclusive
    5. Diagnosis of moderate to severe active UC* made at least 3 months before the screening visit. The diagnosis of UC must have been confirmed by endoscopy, with a minimal extent of 15 cm from anal margin and histology (i.e., histopathology report available in the patient’s fil, however a biopsy for a local histopathology assessment at screening can substitute this requirement).
    *Moderate to severe active UC is defined by a modified Mayo score between 4 and 9, inclusive. The modified Mayo score is defined by the addition of the rectal bleeding sub-score, the stool frequency sub-score, and the endoscopic sub-score. Thus, to be included, a patient must have the following:
    a.a rectal bleeding score ≥ 1,
    b.a stool frequency score ≥ 1 (sub-score calculated before bowel preparation), and
    c.an endoscopic sub-score ≥ 2
    6. Previous or current biologic therapy for UC with documented history of a primary non clinical response or, a secondary loss of response to at least 1 of the following agents used at a dose and regimens approved for the treatment of UC for sufficient time (including approved biosimilars):
    • Anti-TNF-α agents
    • Vedolizumab
    • Ustekinumab
    Or to 1 of the following investigational biologic agents (i.e. not yet approved in UC) used at a therapeutical dose (in such situations, pre-screening discussions with the Medical Monitor of the study will allow to define if the conditions of non-response are met) :
    •Other biologic …
    7. Patient currently receiving 1 or more of the following medication(s) for UC is eligible, provided that he/she has been receiving such treatment(s) for at least 4 weeks and with no change in dose or frequency in the 2 weeks prior to screening:
    a. Oral aminosalicylates anticipating that the dose at screening has to be maintained until Week 10.
    b. Prednisone (stable doses ≤ 20 mg/day) or equivalent, budesonide MMX (stable doses ≤ 9 mg/day), or beclomethasone dipropionate (stable doses ≤ 5 mg/day), anticipating that these stable doses have to be maintained until Week 10.
    If these medications have recently been stopped, the treatment cessation must have occurred at least 2 weeks prior to screening
    8. Patients who have been previously receiving anti-TNF-α therapy or vedolizumab or ustekinumab must have discontinued this therapy ≥ 8 weeks before the date of baseline endoscopy or ≥ 5 half-lives before the date of baseline endoscopy in case of investigational biologics agents .
    9. For patients with UC >8 years, results of a surveillance colonoscopy conducted within 2 years prior to screening are required to rule out dysplasia. This full colonoscopy might be done at screening instead of the procto-sigmoidoscopy to fulfill this requirement.
    10. Either chest x-ray within the 3 months prior to screening and/or a negative quantiFERON TB Gold In Tube test according to local guidelines and standard of care to exclude active or latent TB infection.
    1. Potpisan i datiran informirani pristanak koji pokazuje da je bolesnik upoznat sa svim važnim aspektima ispitivanja prije uključivanja.
    2. Spremnost i mogućnost pridržavati se zakazanih pregleda, planova liječenja, laboratorijskih testiranja i drugih postupaka u okviru ispitivanja.
    3. Pristajanje bolesnika na to da se neće cijepiti živim ili atenuiranim cjepivima tijekom ispitivanja i još 12 tjedana nakon posljednje doze.
    4. Muškarci ili žene u dobi od 18 do uključivo 75 godina.
    5. Dijagnoza umjerenog do teškog oblika ulceroznog kolitisa* postavljena najmanje 3 mjeseca prije probira. Dijagnoza ulceroznog kolitisa morala je biti potvrđena endoskopskim nalazom, u opsegu od najmanje 15 cm od analnog ruba i patohistološki (tj. u bolesnikovoj dokumentaciji mora biti dostupan patohistološki nalaz, međutim, biopsija provedena za lokalnu patohistološku procjenu pri probiru može poslužiti kao zamjena za ovaj zahtjev).
    * Umjereni do teški oblik ulceroznog kolitisa definira se prema modificiranom Mayo indeksu između 4 i uključivo 9. Modificiran Mayo indeks definira se dodavanjem rezultata za rektalno krvarenje, rezultata za učestalost stolice i rezultata endoskopskog nalaza. Dakle, da bi bio uključen, bolesnik mora imati sljedeće:
    a. rezultat za rektalno krvarenje ≥ 1
    b. rezultat za učestalost stolice ≥ 1 (rezultat se izračuna prije pripreme crijeva)
    c. rezultat u nalazu endoskopije ≥ 2.
    6. Prethodna ili sadašnja terapija ulceroznog kolitisa biološkim lijekovima uz dokumentiran primarni izostanak kliničkog odgovora ili sekundarni gubitak odgovora za najmanje:
    - 1 od sljedećih lijekova uzimanih dovoljno dugo u dozi i protokolima odobrenim za liječenje ulceroznog kolitisa (uključujući odobrene bioslične lijekove):
    • antagonisti-TNF α
    • vedolizumab
    • ustekinumab
    - ili 1 od sljedećih ispitivanih bioloških lijekova (tj. lijekova koji još nisu odobreni za ulcerozni kolitis) primjenjivanih u terapijskoj dozi (u takvim će se situacijama u razgovoru s medicinskim motriteljem ispitivanja prije probira moći odrediti jesu li ispunjeni uvjeti izostanka odgovora):
    • mirikizumab
    • rizankizumab
    • guselkumab
    • ostali biološki lijekovi
    7. Bolesnik koji trenutačno uzima 1 ili više sljedećih lijekova protiv ulceroznog kolitisa prikladan je uz uvjet da je takvu terapiju (ili terapije) uzimao najmanje 4 tjedna te da u 2 tjedna prije probira nije bilo promjene doze ili učestalosti:
    a. oralne aminosalicilate, uzimajući u obzir da se doza na probiru mora održavati do 10. tjedna
    b. prednizon (stabilne doze ≤ 20 mg na dan) ili ekvivalent, budezonid MMX (stabilne doze ≤ 9 mg na dan) ili beklometazon dipropionat (stabilne doze ≤ 5 mg na dan), uzimajući u obzir da se te stabilne doze moraju održavati do 10. tjedna.
    Ako su ovi lijekovi nedavno obustavljeni, prestanak terapije morao je biti najmanje 2 tjedna prije probira.
    8. Bolesnici koji su prije primali terapiju antagonistima TNF α ili vedolizumabom ili ustekinumabom morali su prekinuti tu terapiju ≥ 8 tjedana prije datuma endoskopije na početku ispitivanja ili ≥ 5 poluvremena prije datuma endoskopije na početku ispitivanja u slučaju ispitivanih bioloških lijekova.
    9. Za bolesnike s ulceroznim kolitisom koji traje dulje od 8 godina potrebni su rezultati kolonoskopskog pregleda provedenog unutar 2 godine prije probira kako bi se isključila displazija. Ova potpuna kolonoskopska pretraga može se provesti pri probiru umjesto proktosigmoidoskopije kako bi se ispunio ovaj zahtjev.
    10. Rendgenska snimka pluća unutar 3 mjeseca prije probira i/ili negativan test QuantiFERON TB Gold In Tube prema lokalnim smjernicama i standardu skrbi kako bi se isključila aktivna ili latentna tuberkuloza.
    E.4Principal exclusion criteria
    1. Stoma, proctocolectomy, or subtotal colectomy
    2. Physician judgment that patient is likely to require any surgery for UC during the study duration, or double-blind phase duration at least
    3. Evidence of fulminant colitis, toxic megacolon, or perforation
    4. Current or recent (within 4 weeks prior to screening) hospitalization for UC care and/or treatment with IV steroids
    5. The following laboratory results at screening:
    a. Elevation at screening of aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3 × the upper limit of normal (ULN) or total bilirubin > 2 × ULN (unless due to Gilbert’s disease) or evidence of chronic liver disease
    b. Platelet count < 100,000/mm3
    c. Hemoglobin (Hgb) < 8.5 g/dL
    d. Neutrophils < 1500/mm3
    e. Lymphocytes < 800/mm3
    f. Absolute white blood cell (WBC) count < 3000/mm3
    6. Crohn’s disease or indeterminate colitis or any other diagnosis not consisting with UC
    7. History or evidence of incompletely resected colonic dysplasia or unconventional lesion at risk of colonic adenocarcinoma
    8. Stool culture or other examination positive for enteric pathogen, including Clostridium difficile (C. diff) toxin. If positive, the patient should be treated and rescreening is allowed.
    9. Men or women with childbearing potential not willing to use adequate birth control during the study. Adequate birth control includes surgical sterilization, intrauterine device, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner’s vasectomy, double-barrier method (condom, diaphragm with spermicide), or abstinence during study and 30 days following the last follow-up visit. Women of childbearing potential will enter the study after a negative pregnancy test.
    10. Breastfeeding
    11. Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) from screening through the end of the study
    12. Use of topical steroids and/or topical 5-aminosalicylic acid preparations within 2 weeks before the screening visit (all such medications should be withdrawn at least 2 weeks prior to the screening visit)
    13. Use of antidiarrheals within 2 weeks before the screening visit (all such medications should be withdrawn at least 2 weeks prior to the screening visit)
    14. Treatment with azathioprine, 6-MP, methotrexate (MTX), cyclosporin, tacrolimus, sirolimus, leflunomide and/or mycophenolate mofetil within 4 weeks before the screening visit (all such medications should be withdrawn at least 4 weeks prior to the screening visit)
    15. Previous failure to more than 3 biologics including anti-TNF-α and/or anti-integrin and/or ustekinumab and/or any other biologics agents
    16. Prior treatment with a JAK inhibitor
    17. Clinically relevant cardiovascular, hepatic, neurologic, psychiatric, pulmonary, endocrine, or other major systemic disease that would put the patient at risk by participating in the study in the opinion of the investigator
    18. A recognized hereditary, congenital, or acquired immunodeficiency disease including human immunodeficiency virus (HIV) infection and other cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia
    19. Known active viral, bacterial, fungal, mycobacterial infection, or other infection or any major infection that required hospitalization or treatment with IV antibiotics or antifungal within 30 days of screening or that required treatment with oral antibiotics within 14 days of screening
    20. History or known presence of chronic or recurrent infection (hepatitis B, C, HIV)
    21. Any autoimmune disease, other than UC, with the exception of controlled Type I diabetes (hemoglobin A1c ≤8%) or treated hypothyroidism
    22. Evidence of active malignancy
    23. Live vaccine received within 4 weeks prior to screening
    24. Previous treatment with lymphocyte-depleting agents such as alemtuzumab; alkylating agents such as cyclophosphamide or chlorambucil; total lymphoid irradiation; or selective B lymphocyte-depleting agents such as rituximab
    25. Current or previous treatment with investigational therapy in another therapeutic clinical trial within 8 weeks or 5 half-lives before the date of baseline endoscopy
    26. History of alcohol or drug abuse within 1 year of screening
    27. Previous completion or withdrawal from this study. This criterion does not apply to participants undergoing rescreening procedures.
    1. Stoma, proktokolektomija ili subtotalna kolektomija.
    2. Liječnikova prosudba da će zbog ulceroznog kolitisa bolesniku vjerojatno biti potreban kirurški zahvat tijekom trajanja ispitivanja ili barem tijekom trajanja dvostruko slijepe faze.
    3. Dokaz fulminantnog kolitisa, toksičnog megakolona ili perforacije.
    4. Sadašnja ili nedavna (unutar 4 tjedna prije probira) hospitalizacija zbog ulceroznog kolitisa i/ili liječenja i.v. steroidima.
    5. Sljedeći laboratorijski nalazi na probiru:
    a. povišenje aminotransferaze (AST), alanin aminotransferaze (ALT) > 3 × od gornje granice normale (GGN) ili ukupnog bilirubina > 2 × GGN (osim ako je to zbog Gilbertove bolesti) ili dokaz kronične bolesti jetre na probiru
    b. trombociti < 100 000/mm3
    c. hemoglobin (Hgb) < 8,5 g/dl
    d. neutrofili < 1500/mm3
    e. limfociti < 800/mm3
    f. apsolutni broj leukocita < 3000/mm3.
    6. Crohnova bolest ili nerazvrstani kolitis ili bilo koja druga dijagnoza koja nije povezana s ulceroznim kolitisom.
    7. Anamneza ili dokaz nepotpune resekcije displazije crijeva ili nekonvencionalna lezija s rizikom za adenokarcinom crijeva.
    8. Kultura stolice ili drugi pregled pozitivan na enteropatogene, uključujući toksin Clostridium difficile (C. diff). Ako su nalazi pozitivni, bolesnika valja liječiti i dopušten je ponovni probir.
    9. Muškarci ili žene reproduktivnog potencijala koji tijekom ispitivanja ne žele primjenjivati odgovarajuću kontracepciju. Odgovarajuća metoda kontracepcije uključuje kiruršku sterilizaciju, unutarmaternični uložak, oralne kontraceptive, kontracepcijski naljepak, dugodjelujuće kontraceptive u injekciji, vazektomiju partnera, metodu dvostruke mehaničke kontracepcije (kondom, dijafragma sa spermicidom) ili ustezanjeod spolnih odnosa tijekom ispitivanja i 30 dana poslije posljednjeg kontrolnog pregleda. Žene reproduktivnog potencijala uključit će se u ispitivanje nakon negativnog testa na trudnoću.
    10. Dojenje
    11. Kronična upotreba nesteroidnih protuupalnih lijekova (NSAID) od probira do kraja ispitivanja.
    12. Primjena topikalnih steroida i/ili topikalnih pripravaka 5-aminosalicilatne kiseline unutar 2 tjedna prije probira (sve takve lijekove treba obustaviti najmanje 2 tjedna prije probira).
    13. Upotreba lijekova protiv proljeva unutar 2 tjedna prije probira (sve takve lijekove treba obustaviti najmanje 2 tjedna prije probira).
    14. Liječenje azatioprinom, 6 MP, metotreksatom (MTX), ciklosporinom, takrolimusom, sirolimusom, leflunomidom i/ili mikofenolat mofetilom unutar 4 tjedna prije probira (sve takve lijekove treba obustaviti najmanje 4 tjedna prije probira).
    15. Prethodno neuspješno liječenje s više od 3 biološka lijeka uključujući antagonist TNF-α i/ili anti-integrin i/ili ustekinumab i/ili neki drugi biološki lijek.
    16. Prethodno liječenje inhibitorom JAK a.
    17. Klinički relevantna kardiovaskularna, hepatička, neurološka, psihijatrijska, plućna, endokrina bolest ili druga velika sistemska bolest zbog koje bi sudjelovanjem u ispitivanju, prema mišljenju ispitivača, bolesnik mogao biti izložen riziku.
    18. Prepoznata nasljedna, kongenitalna ili stečena imunodeficijencija, uključujući infekciju virusom humane imunodeficijencije (HIV) i druge stanične imunodeficijencije, hipogamaglobulinemija ili disgamaglobulinemija.
    19. Poznata aktivna virusna, bakterijska, gljivična, mikobakterijska infekcija ili druga infekcija ili velika infekcija koja je zahtijevala hospitalizaciju ili liječenje i.v. antibioticima ili antimikoticima unutar 30 dana od probira, ili je zahtijevala liječenje oralnim antibioticima unutar 14 dana od probira.
    20. Anamneza ili je poznato da je sada prisutna kronična rekurentna infekcija (hepatitis B, C, HIV).
    21. Bilo koja autoimunosna bolest osim ulceroznog kolitisa, uz izuzetak kontroliranog dijabetesa tip I (hemoglobin A1c ≤ 8%) ili liječene hipotireoze.
    22. Dokaz aktivne zloćudne bolesti.
    23. CijeCijepljenje živim cjepivom unutar 4 tjedna prije probira. ljCijepljenje živim cjepivom unutar 4 tjedna prije probira.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline in the modified Mayo Score at Week 10 exploring the clinical symptoms (stool frequency and rectal bleeding sub-scores) additionally to the endoscopic sub-score
    Srednja vrijednost promjene u odnosu na početnu vrijednost u rezultatu modificiranog Mayo indeksa u 10. tjednu eksploracijom kliničkih simptoma (rezultati za učestalost stolice i rektalno krvarenje) kao dodatak rezultatu endoskopskog nalaza.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 10
    10. tjedan.
    E.5.2Secondary end point(s)
    _Number and proportion of patients in clinical remission at Week 10, defined as a modified Mayo score of ≤ 2 points and with no individual sub-score of > 1 point and a rectal bleeding at 0, therefore a stool frequency score of 0 or 1 and an endoscopic score of 0 or 1
    _Number and proportion of patients with a clinical response at Week 10 defined as a reduction in the modified Mayo score of ≥ 3 points and of ≥ 30% from baseline, with an accompanying decrease from baseline in the rectal bleeding sub-score of ≥ 1 point or an absolute rectal bleeding sub-score of ≤ 1 point
    _Number and proportion of patients with an endoscopic remission at Week 10 defined by an endoscopic Mayo sub-score =0
    _Number and proportion of patients with endoscopic response or improvement at Week 10 defined by an endoscopic sub-score of Mayo ≤ 1 point
    _Mean change from baseline in the endoscopic activity measured at Week 10 by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)
    _Adverse events (AEs), serious AEs (SAEs), AEs leading to the discontinuation of study treatment, target AEs of special interest, laboratory abnormalities, vital signs, electrocardiogram (ECG), and physical examination abnormalities
    _Broj i udio bolesnika u kliničkoj remisiji u 10. tjednu, definirano kao modificirani Mayo indeks od ≤ 2 boda, bez pojedinog rezultata > 1 boda, s rektalnim krvarenjem 0, dakle rezultat za učestalost stolice 0 ili 1 i endoskopski rezultat 0 ili 1.
    _Broj i udio bolesnika s kliničkim odgovorom u 10. tjednu definiranom kao smanjenje modificiranog Mayo indeksa za ≥ 3 boda i za ≥ 30% od početne vrijednosti, s popratnim smanjenjem rezultata za rektalno
    krvarenje ≥ 1 boda ili apsolutnim rezultatom za rektalno krvarenje ≤ 1 boda od početne vrijednosti.
    _Broj i udio bolesnika s endoskopski utvrđenom remisijom u 10. tjednu definirano endoskopskim rezultatom Mayo indeksa =0.
    _Broj i udio bolesnika s endoskopski utvrđenim odgovorom ili poboljšanjem u 10. tjednu definirano endoskopskim rezultatom Mayo indeksa ≤ 1 boda.
    _Srednja vrijednost promjene u odnosu na početnu vrijednost u rezultatu endoskopski utvrđene aktivnosti izmjerene u 10. tjednu prema endoskopski utvrđenom indeksu težine ulceroznog kolitisa (engl. Ulcerative Colitis Endoscopic Index of Severity, UCEIS).
    _Štetni događaji (AE), ozbiljni štetni događaji (SAE), štetni događaji koji su doveli do prestanka primjene ispitivane terapije, ciljni štetni događaji od posebnog interesa, odstupanja laboratorijskih nalaza, vitalni
    znakovi, elektrokardiogram (EKG) i abnormalnosti na tjelesnom pregledu.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Week 10 for the efficacy objectives and throughout the clinal trial for the safety and tolerability objectives
    10. tjedan za učinkovitost te tijekom cijelog perioda ispitivanja za sigurnost i toleranciju.
    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 Yes
    E.6.13.1Other scope of the trial description
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    South Africa
    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
    Posljednji posjet posljednjeg ispitianika
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 126
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    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)
    Other available therapy according to investigator's decision
    Dostupna terapija prema odluci ispitivača
    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 Decision2020-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-24
    P. End of Trial
    P.End of Trial StatusOngoing
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