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    Summary
    EudraCT Number:2019-003596-19
    Sponsor's Protocol Code Number:CHS1221
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-003596-19
    A.3Full title of the trial
    A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with
    Ulcerative Colitis of the Rectum.
    Studio di fase III a tre bracci, randomizzato, controllato con placebo e in doppio cieco volto a valutare la sicurezza e l'efficacia della somministrazione una volta al giorno e due volte al giorno di una nuova formulazione in supposta di idrocortisone acetato 90 mg mediante l'applicatore per supposte Sephure® in soggetti affetti da colite ulcerosa del retto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with
    Ulcerative Colitis of the Rectum.
    Studio di fase III a tre bracci, randomizzato, controllato con placebo e in doppio cieco volto a valutare la sicurezza e l'efficacia della somministrazione una volta al giorno e due volte al giorno di una nuova formulazione in supposta di idrocortisone acetato 90 mg mediante l'applicatore per supposte Sephure® in soggetti affetti da colite ulcerosa del retto
    A.3.2Name or abbreviated title of the trial where available
    CESSA
    CESSA
    A.4.1Sponsor's protocol code numberCHS1221
    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 SponsorCristcot HCA LLC
    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 supportCRISTCOT HCA LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCristcot HCA LLC
    B.5.2Functional name of contact pointcessa Information
    B.5.3 Address:
    B.5.3.1Street Address9 Damonmill Square, Suite 4A
    B.5.3.2Town/ cityConcord
    B.5.3.3Post code01742
    B.5.3.4CountryUnited States
    B.5.6E-mailresearch@cessa-uc.com
    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 name90 mg idrocortisone acetato in supposta con applicatore per supposte Sephure
    D.3.2Product code [90 mg idrocortisone acetato in supposta con appli
    D.3.4Pharmaceutical form Suppository
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIDROCORTISONE ACETATO
    D.3.9.2Current sponsor codeIDROCORTISONE ACETATO
    D.3.9.4EV Substance CodeSUB02562MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    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 placeboSuppository
    D.8.4Route of administration of the placeboRectal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis of the Rectum
    Colite ulcerosa del retto
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis of the Rectum
    Colite ulcerosa del retto
    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 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10009900
    E.1.2Term Colitis ulcerative
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10027682
    E.1.2Term Immune and associated conditions NEC
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10021428
    E.1.2Term Immune system disorders
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10027665
    E.1.2Term Immune disorders NEC
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of two dosage regimens of the study drug (hydrocortisone acetate 90 mg suppository) administered with the Sephure suppository applicator compared to placebo in the treatment of ulcerative colitis (UC) of the rectum using the Modified Mayo Score.
    Valutare l'efficacia di due regimi posologici del farmaco in studio (idrocortisone acetato 90 mg in supposta) somministrato mediante l'applicatore per supposte Sephure rispetto al placebo nel trattamento della colite ulcerosa (Ulcerative Colitis, UC) del retto utilizzando il punteggio
    Mayo modificato.
    E.2.2Secondary objectives of the trial
    Reduction of stool frequency and rectal bleeding sub-score of 0 (MMDAI).
    Riduzione della frequenza delle evacuazioni e sottopunteggio di sanguinamento rettale pari a 0 (MMDAI).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or non-pregnant, non-lactating females aged 18 years and older.
    • Subjects with a confirmed diagnosis of active UC of the rectum, extending no more than 15 centimeters (cm) (5.9 inches) proximal to the anal verge as assessed by colonoscopy performed at Visit 2. Note: Subjects may have a history of more extensive UC (e.g., pancolitis), but have active disease only in the rectum at the time of enrollment.
    • Modified Mayo sub-score for stool frequency of 1-3.
    • Modified Mayo sub-score for rectal bleeding of 0-2.
    • Modified Mayo endoscopic sub-score of 2-3.
    • Total Modified Mayo Score (without physician global assessment) of 3-8.
    - Soggetti di sesso maschile o di sesso femminile non in gravidanza né in allattamento di età pari o superiore a 18 anni.
    - Soggetti con diagnosi confermata di UC attiva del retto, che si estende per non più di 15 centimetri (cm) prossimalmente alla verga anale, come valutato dalla colonscopia eseguita alla Visita 2. Nota: i soggetti possono avere un'anamnesi di UC più estesa (ad es. pancolite), ma possono avere una malattia attiva solo nel retto al momento dell'arruolamento.
    - Sottopunteggio Mayo modificato per la frequenza delle evacuazioni pari a 1-3.
    - Sottopunteggio Mayo modificato per il sanguinamento rettale pari a 0-2.
    - Sottopunteggio endoscopico Mayo modificato pari a 2-3.
    - Punteggio Mayo modificato totale (senza valutazione globale del medico) pari a 3-8.
    E.4Principal exclusion criteria
    • History or current diagnosis of bacterial or other infectious colitis, radiation-enteritis and radiation-proctitis, Crohn’s disease, collagenous colitis and indeterminate colitis.
    • Prior gastrointestinal surgery except appendectomy, cholecystectomy, and hernia.
    • Concomitant active lower gastrointestinal disease (except Irritable Bowel Syndrome) or distortion of intestinal anatomy.
    • Bleeding hemorrhoids at the time of enrollment.
    • Acute diverticulitis at the time of enrollment.
    • Acute or chronic pancreatitis at the time of enrollment.
    • Unmanaged celiac disease at the time of enrollment.
    • Positive stool test for enteric pathogens, Clostridium difficile, or presence of ova and parasites.
    • Taking a prohibited medication. Some medications to treat UC/irritable bowel syndrome (IBS) are prohibited during participation in the study. Prohibited medications include non-study corticosteroids, laxatives and antidiarrheal medications, and any medication delivered rectally (e.g., rectal 5-aminosalicylic acid [5-ASA medication]); however, oral 5-ASA agents at doses up to 4.8 g/day and daily fiber supplements are allowed. Subjects taking 5-ASA, and/or immunomodulatory agents will be stratified appropriately. Other medications (e.g., antibiotics, anti-seizure and anticoagulant medicines) are also prohibited.
    - Anamnesi o diagnosi attuale di colite batterica o altra colite infettiva, enterite da radiazioni e proctite da radiazioni, morbo di Crohn, colite collagena e colite indeterminata.
    - Interventi chirurgici gastrointestinali precedenti ad eccezione di appendicectomia, colecistectomia ed ernia.
    - Malattia concomitante del tratto gastrointestinale inferiore attiva (ad eccezione della sindrome dell'intestino irritabile) o distorsione dell'anatomia intestinale.
    - Emorroidi sanguinanti al momento dell’arruolamento.
    - Diverticolite acuta al momento dell'arruolamento.
    - Pancreatite acuta o cronica al momento dell'arruolamento.
    - Celiachia non gestita al momento dell'arruolamento.
    - Test positivo delle feci per agenti patogeni enterici, Clostridium difficile o presenza di ovuli e parassiti.
    - Assunzione di un farmaco vietato. Durante la partecipazione allo studio sono vietati alcuni farmaci per il trattamento della sindrome dell'intestino irritabile (IBS)/UC. Tra i farmaci vietati si annoverano i corticosteroidi non in studio, lassativi e farmaci antidiarroici, nonché qualsiasi farmaco somministrato per via rettale (ad es. acido 5-aminosalicilico rettale [farmaco 5-ASA]); tuttavia, sono ammessi agenti 5-ASA orali a dosi pari a massimo 4,8 g al giorno e integratori di fibre giornalieri. I soggetti che assumono 5-ASA e/o agenti immunomodulanti verranno stratificati opportunamente. Sono vietati anche altri farmaci (ad es. antibiotici, farmaci antiepilettici e anticoagulanti).
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is the proportion of subjects with clinical remission at the End of Treatment Visit (Visit 7). As shown in the table below, clinical
    remission is defined as the Modified Mayo Total Score of 0 to 2, with, stool frequency sub-score of 0 or 1 (minimum 1 point decrease from
    baseline), rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1.
    L'endpoint primario è la percentuale di soggetti con remissione clinica alla Visita di fine trattamento (Visita 9). Come mostrato nella tabella seguente, la remissione clinica è definita come il punteggio Mayo totale modificato pari a 0-2, con un sottopunteggio della frequenza
    delle evacuazioni pari a 0 o 1 (diminuzione di almeno 1 punto dal basale), un sottopunteggio del sanguinamento rettale pari a 0 e un sottopunteggio endoscopico pari a 0 o 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 29
    Giorno 29
    E.5.2Secondary end point(s)
    Reduction of stool frequency defined as a reported score of 0 or 1, with at least a reduction of 1 point from baseline and absence of rectal bleeding (MMDAI sub-score of 0) defined as a reported score of 0.
    Riduzione della frequenza delle evacuazioni definita come un punteggio riportato di 0 o 1, con almeno una riduzione di 1 punto rispetto al basale e assenza di sanguinamento rettale (sottopunteggio MMDAI pari a 0) definita come un punteggio riportato pari a 0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 15 and Day 29
    Giorno 15 e giorno 29
    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 No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Design adattivo con analisi provvisoria che consente la risoluzione anticipata di uno o entrambi i b
    Adaptive design with interim analysis allowing for early termination of one or both active arms.
    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 trial3
    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 concerned6
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Hong Kong
    India
    Philippines
    Russian Federation
    Ukraine
    United States
    Germany
    Italy
    Poland
    Spain
    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
    Cristcot anticipates that the end of the trial will be the last visit of the last subject (LVLS); however, Cristcot has also incorporated into this
    study two interim analyses for efficacy at approximately 60% and 75% of the randomized subjects have reached their primary analysis
    endpoint.
    Cristcot prevede che la fine dello studio sarà l'ultima visita dell'ultimo soggetto (LVLS); tuttavia, Cristcot ha anche incorporato in questo
    studio due analisi intermedie per l'efficacia a quando circa il 60% e il 75% dei soggetti randomizzati avrà raggiunto la propria analisi endpoint primaria.
    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 months4
    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: 587
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 237
    F.4.2.2In the whole clinical trial 618
    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)
    No plans for treatment or care after participation in the clinical trial. Subject resumes care with their medical professional.
    Nessun piano di trattamento o cura dopo la partecipazione alla sperimentazione clinica. Il soggetto riprende le cure con il proprio medico.
    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 Decision2020-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-24
    P. End of Trial
    P.End of Trial StatusOngoing
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