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    Summary
    EudraCT Number:2011-004581-14
    Sponsor's Protocol Code Number:A3921139
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-07
    Trial results View 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 number2011-004581-14
    A.3Full title of the trial
    A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
    STUDIO MULTICENTRICO, IN APERTO DI CP-690,550 IN SOGGETTI CON COLITE ULCEROSA DA MODERATA A GRAVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis
    Studio multicentrico, in aperto di CP-660,550 in soggetti con colite ulcerosa da moderata a grave
    A.4.1Sponsor's protocol code numberA3921139
    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 SponsorPFIZER LIMITED
    B.1.3.4CountryUnited Kingdom
    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 supportPfizer Limited
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Limited, Ramsgate Road, Sandwick, Kent, UK
    B.5.2Functional name of contact pointICON Clinical ResearchStartUp Team
    B.5.3 Address:
    B.5.3.1Street AddressConcept House, 6 Stoneycroft Rise, Chandlers Ford
    B.5.3.2Town/ cityEastleigh, Hampshire
    B.5.3.3Post codeS053 3LD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0) 2380 688500
    B.5.5Fax number+44 (0) 2081 005001
    B.5.6E-mailkellie.macleod@iconplc.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 nameNA
    D.3.2Product code CP-690,550-10
    D.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550-10
    D.3.9.3Other descriptive nametofacitinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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.IMP: 2
    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 nameNA
    D.3.2Product code CP-690,550-10
    D.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550-10
    D.3.9.3Other descriptive nametofacitinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative colitis (UC)
    Colite Ulcerosa (CU)
    E.1.1.1Medical condition in easily understood language
    Ulcerative collitis (UC)
    Colite ulcerosa (CU)
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045282
    E.1.2Term UC
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 assess the safety and tolerability of long-term CP 690,550 therapy in subjects with UC.
    Valutare la sicurezza e la tollerabilità a lungo termine della terapia con CP-690,550 in soggetti affetti da colite ulcerosa.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of long term CP 690,550 therapy in subjects with UC. - To evaluate the effect of long term CP 690,550 therapy on quality-of-life in subjects with UC.
    •Valutare l'efficacia a lungo termine della terapia con CP-690,550 in soggetti affetti da colite ulcerosa.•Valutare l'effetto a lungo termine della terapia CP-690,550 sulla qualità della vita in soggetti affetti da colite ulcerosa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects previously participated in Study A3921096 who either: a)completed 52 week maintenance treatment in Study A3921096, or b) were early withdrawals from Study A3921096 and met treatment failure criteria defined by an increase in Mayo score of at least 3 points from baseline value of the maintenance study (A3921096), accompanied by an increase in rectal bleeding subscore by at least 1 point, and an increase of endoscopic subscore of at least 1 point (yielding an absolute endoscopic subscore of ≥2), after a minimum of 8 weeks of treatment in the maintenance study. Note, endoscopic subscores based on central reading will be used to assess treatment failure. 2. Subjects who previously participated in the induction Study A3921094 or A3921095 who: a)did not demonstrate clinical response after completing 8 weeks of treatment. Clinical response is defined by a decrease from baseline in Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1, and b)have an endoscopic subscore at Week 8 that is either the same or higher (worse) than the endoscopic subscore at Week 0 of Study A3921094 or A3921095. 3. Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 28 days after the last dose of assigned treatment. 4. Women of childbearing potential must have a negative pregnancy test prior to study enrollment. 5. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 6. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    1.Soggetti che hanno già preso parte allo studio A3921096 e che: a)hanno completato 52 settimane di trattamento di mantenimento nello studio A3921096, o b) sono stati prematuramente ritirati dallo studio A3921096 ed hanno sperimentato fallimento del trattamento definito da un aumento del punteggio Mayo di almeno 3 punti dal valore al basale dello studio di mantenimento (A3921096) accompagnato da un aumento del sottopunteggio di sanguinamento rettale di almeno 1 punto e un aumento del sottopunteggio endoscopico di almeno 1 punto (producendo un sottopunteggio endoscopico assoluto ≥2), dopo minimo 8 settimane di trattamento nello studio di mantenimento. Nota: per valutare il fallimento del trattamento sarà utilizzato il sottopunteggio endoscopico basato su lettura centralizzata. 2. soggetti che hanno partecipato allo studio di induzione A3921094 o A3921095 e che: a)non hanno mostrato risposta clinica dopo il completamento di 8 settimane di trattamento. La risposta clinica è definita da una riduzione del punteggio Mayo di almeno 3 punti e almeno il 30% rispetto al basale dello studio, accompagnata da riduzione del sottopunteggio di sanguinamento rettale di almeno 1 punto o del sottopunteggio di sanguinamento rettale assoluto di 0 o 1, e b)con sottopunteggio endoscopico alla settimana 8 pari o più alto (peggiore) del sottopunteggio endoscopico alla settimana 0 degli studi A3921094 o A3921095. 3.Le donne potenzialmente fertili devono adottare un metodo di contraccezione efficace per tutta la durata dello studio e per almeno 28 giorni dopo l'ultima dose di trattamento assegnato. 4.Donne potenzialmente fertili devono avere un test di gravidanza negativo prima dell'arruolamento nello studio. 5.Soggetti disposti e in grado di rispettare le visite programmate, il programma di terapia, gli esami di laboratorio e le altre procedure di studio. 6.Evidenza di rilascio di consenso informato personalmente firmato e datato indicante che il soggetto (o un suo rappresentate legale) è stato informato su tutti gli aspetti pertinenti dello studio.
    E.4Principal exclusion criteria
    1. Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096. 2. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease. 3. Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period. 4. Subjects who are expected to receive any of prohibited medications, including medications that are either moderate to potent CYP3A inducers or inhibitors, during the study period as specified in the protocol. 5. Subjects who are expected to receive live or attenuated virus vaccination during study period and for 6 weeks after last dose of study medication. 6. Women who are pregnant or lactating, or planning to become pregnant during the study period. 7. Baseline 12 lead ECG that demonstrates clinically relevant abnormalities which may affect subject safety or interpretation of study results. 8. Subjects who, in the opinion of the investigator or Pfizer, will be uncooperative or unable to comply with study procedures. 9. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 10. Subjects who are or interested in participating in other investigational studies during study participation.
    1.Soggetti con violazioni maggiori al protocollo durante la partecipazione allo studio A3921094 o A3921095. 2.Presenza di colite indeterminata, colite microscopica, colite ischemica, colite infettiva, o sintomi clinici suggestivi di morbo di Crohn. 3.Soggetti già sottoposti a intervento chirurgicoper CU o che, nell'opinione dello sperimentatore, potrebbero necessitare di chirurgia per CU durante il periodo di studio. 4.Soggetti che durante il periodo di studio si prevede possano assumere farmaci concomitanti vietati, incluso moderati o potenti induttori o inibitori di CYP3A, come specificato nel protocollo. 5.Soggetti che si prevede possano ricevere vaccinazioni con virus vivi attenuati durante il periodo in studio e per 6 settimane dopo l'ultima dose del farmaco in studio. 6.Donne incinte o in allattamento, o che prevedono di iniziare una gravidanza durante il periodo di studio 7.ECG basale a 12 derivazioni che dimostri anomali clinicamente rilevanti che possano compromettere la sicurezza del soggetto o influenzare l'interpretazione dei risultati dello studio. 8.Soggetti che, nell'opinione dello sperimentatore o di Pfizer, non saranno collaborativi o rispettosi delle procedure dello studio. 9.Qualunque condizione medica o psichiatrica severa acuta o cronica o anomalia di laboratorio che possa aumentare il rischio associato con la partecipazione allo studio o la somministrazione del prodotto sperimentale o possa interferire con l'interpretazione dei risultati dello studio e, secondo il giudizio dello sperimentatore, renderebbe inappropriato l'arruolamento del soggetto nello studio. 10.Soggetti che stanno partecipando o hanno interesse a partecipare ad altri studi sperimentali durante la partecipazione al presente studio
    E.5 End points
    E.5.1Primary end point(s)
    - As this is an open label extension study, there will be no primary efficacy endpoint - Incidence and severity of adverse events.
    - Trattandosi di studio di estensione in aperto, non sono previsti endpoint primari di efficacia - incidenza e severità degli eventi avversi
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ongoing incidence and severity of adverse events
    valutazione dell'incidenza e della severità degli eventi avversi in tutta la durata dello studio
    E.5.2Secondary end point(s)
    • Proportion of subjects in remission at Months 2, 12, 24 and 36. • Proportion of subjects in remission at Months 2, 12, 24, and 36 among four subgroups of subjects based on the status at baseline of Study A3921139: 1) in remission, 2) treatment failure, 3) all other subjects from study A3921096 neither in remission nor fulfilling the definition of treatment failure, and 4) non responders from induction studies A3921094 or A3921095. • Proportion of subjects in partial Mayo score (PMS) remission over time. • Proportion of subjects in PMS remission over time among the four subgroups of subjects described above. • PMS and change from Baseline (of Study A3921139) over time. • Proportion of subjects who achieve mucosal healing at Months 2, 12, 24 and 36. • Proportion of subjects with total score in IBDQ ≥170 over time. • Incidence of serious infections. - Other secondary, exploratory, pharmacokinetic, biomarker, Health Outcome and safety endpoints are described within the protocol
    • Percentuale di soggetti in remissione nei mesi 2, 12, 24 e 36. • Percentuale dei soggetti in remissione nei mesi 2, 12, 14 e 36 tra i seguenti quattro sottogruppi di soggetti sulla base dello stato al basale dello studio A3921139: 1) in remissione; 2) fallimento del trattamento; 3) tutti gli altri soggetti provenienti dallo studio di mantenimento A3921096 che non sono né in remissione né rientrano nella definizione di fallimento del trattamento; 4) i non-responder degli studi di induzione A3921094 o A3921095. • Percentuale di soggetti in remissione secondo il punteggio Mayo parziale (PMS) nel corso del tempo. • Percentuale dei soggetti in remissione PMS nel corso del tempo tra i quattro sottogruppi di soggetti descritti sopra. • Punteggio Mayo parziale e cambiamento dal basale (dello studio A3921139) nel corso del tempo. • Percentuale di soggetti che hanno ottenuto la guarigione della mucosa nei mesi 2, 12, 24 e 36. • Percentuale dei soggetti con un punteggio totale del questionario sulla malattia intestinale infiammatoria (Inflammatory Bowel Disease Questionnaire, IBDQ) ≥170 nel corso del tempo. • Incidenza di infezioni gravi - Other secondary, exploratory, pharmacokinetic, biomarker, Health Outcome and safety endpoints are described within the protocol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints are measured at Months 2, 12, 24 and 36.
    Gli endpoint secondari sono misurati al Mese 2, 12, 24 e 36.
    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 No
    E.6.7Pharmacodynamic No
    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
    Tolerability, Quality of Life
    Tollerabilità, Qualità della Vita
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Australia
    Brazil
    Canada
    Colombia
    India
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    South Africa
    Taiwan
    Ukraine
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months46
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months48
    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.1.1Number of subjects for this age range: 0
    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: 595
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 725
    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)
    When the trial completes the patient will revert to the local standard of care for ulcerative colitis.
    Al completamento dello studio i soggetti saranno trattati secondo standard di cura locale per il trattamento della colite ulcerosa
    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 Decision2013-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-29
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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