Studie for å evaluere den kliniske aktiviteten og sikkerheten til Oral NX-13 ved moderat til alvorlig ulcerøs kolitt
En randomisert, dobbeltblind, placebokontrollert, multisenter fase 2-induksjonsstudie med flere doser med langtidsforlengelse for å evaluere den kliniske aktiviteten og sikkerheten til Oral NX-13 hos deltakere med moderat til alvorlig ulcerøs kolitt
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
-
Leuven, Belgia
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg
-
-
-
-
Florida
-
Miami, Florida, Forente stater, 33155
- Miami Clinical Research
-
Orlando, Florida, Forente stater, 32806
- Orlando Health, Inc.
-
Tampa, Florida, Forente stater, 33609
- GCP Clinical Research
-
-
Michigan
-
Chesterfield, Michigan, Forente stater, 48047
- Digestive Health Center of Michigan
-
Troy, Michigan, Forente stater, 48098
- Clinical Research Institute of Michigan
-
-
Missouri
-
St Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine in St. Louis
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forente stater, 73112
- Digestive Disease Specialist, Inc-INTEGRIS Baptist Medical Center
-
-
Texas
-
Garland, Texas, Forente stater, 75044
- Digestive Health Associates of Texas-GI Alliance Research-Garland
-
Mansfield, Texas, Forente stater, 76003
- Digestive Health Associates of Texas-GI Alliance
-
Southlake, Texas, Forente stater, 76092
- Texas Digestive Disease Consultants-GI Alliance Research
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forente stater, 53226
- Medical College of Wisconsin
-
-
-
-
-
Milan, Italia
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
-
Roma, Italia
- Azienda Ospedaliera - Universitaria Sant' Andrea
-
Rozzano, Italia
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
-
San Giovanni Rotondo, Italia
- IRCCS Fondazione Casa Sollievo della Sofferenza SG Rotondo
-
Torino, Italia
- Azienda Ospedaliera Ordine Mauriziano Di Torino
-
-
-
-
-
Bydgoszcz, Polen
- ClinSante - Ośrodek Badań Klinicznych w Bydgoszczy
-
Bydgoszcz, Polen
- Przychodnia Vitamed NFZ
-
Jelenia Góra, Polen
- Amicare Centrum Medyczne
-
Katowice, Polen
- VITA LONGA Clinic - Katowice
-
Krakow, Polen
- Krakowska Przychodnia FutureMeds
-
Lodz, Polen
- Amicare Sp. z o.o. Sp.k.
-
Opoczno, Polen
- Amicare Sp z o.o. S.K
-
Opole, Polen
- Twoja Przychodnia Opolskie Centrum Medyczne
-
Poznan, Polen
- RiverMED Poradnie Specjalistyczne Poznań
-
Sopot, Polen
- Endoskopia Sp. z o.o.
-
Szczecin, Polen
- Sonomed Sp. z o.o. Centrum Medyczne
-
Szczecin, Polen
- Twoja Przychodnia Szczecińskie Centrum Medyczne
-
Torun, Polen
- Torunskiego Centrum Gastrologii I Endoskopii - Gastromed
-
Tychy, Polen
- H-T Centrum Medyczne
-
Warsaw, Polen
- Office of Jaroslaw Kierkus, Dr N Med
-
Wroclaw, Polen
- Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
-
Wroclaw, Polen
- Zabobrze Centrum Medyczne
-
Włocławek, Polen
- Centrum Diagnostyczno - Lecznicze Barska
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
- Voksne personer i alderen 18 til 75 år (inkludert)
- Diagnose av UC ≥ 90 dager før screening bekreftet av histologisk bevis
- Aktiv UC definert som en total Mayo Score (MMS) på ≥ 5 (inklusive) ved baseline
- ES ≥ 2 innen 14 dager før randomisering
- RBS ≥ 1.
Ekskluderingskriterier:
- Alvorlig omfattende kolitt som dokumentert av legens vurdering av at deltakeren sannsynligvis vil kreve sykehusinnleggelse for medisinsk behandling eller kirurgisk inngrep av noe slag for UC (f.eks. kolektomi) innen 12 uker etter randomisering;
- Aktuelle bevis på fulminant kolitt, giftig megacolon eller nyere historie (innen 6 måneder før screening) av giftig megacolon eller tarmperforasjon
- Diagnose av Crohns sykdom (CD) eller ubestemt kolitt, eller tilstedeværelse eller historie av en fistel i samsvar med CD
- Diagnose av mikroskopisk kolitt, iskemisk kolitt eller strålingskolitt
- bakteriell eller parasittisk patogen enterisk infeksjon;
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: NX-13 250 mg
Forsøkspersonene vil ta studiemedisin ved å innta tre tabletter per dag, anbefalt på samme tid daglig for konsistens.
Personer i en NX-13-gruppe vil motta enten 250 mg eller 750 mg NX-13 i 3 tabletter, og forsøkspersoner i placebogruppen vil motta matchende placebo.
|
NX-13 250 mg tablett, pluss 2 placebotabletter
|
|
Eksperimentell: NX-13 750 mg
Forsøkspersonene vil ta studiemedisin ved å innta tre tabletter per dag, anbefalt på samme tid daglig for konsistens.
Personer i en NX-13-gruppe vil motta enten 250 mg eller 750 mg NX-13 i 3 tabletter, og forsøkspersoner i placebogruppen vil motta matchende placebo.
|
NX-13 250 mg tabletter ganger 3 til lik 750 mg
|
|
Placebo komparator: NX-13 Placebo
Forsøkspersonene vil ta studiemedisin ved å innta tre tabletter per dag, anbefalt på samme tid daglig for konsistens.
Personer i en NX-13-gruppe vil motta enten 250 mg eller 750 mg NX-13 i 3 tabletter, og forsøkspersoner i placebogruppen vil motta matchende placebo.
|
NX-13 Placebo-tabletter ganger 3 for blendende formål
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Modified Mayo Score (MMS) at Week 12
Tidsramme: Baseline, Week 12
|
The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency [SFS], rectal bleeding [RBS] and finding on endoscopy [ES]), each of which ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status.
A negative change in MMS score indicates improvement.
|
Baseline, Week 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Induction Period
Tidsramme: Baseline up to Week 12
|
Treatment-emergent adverse events (TEAEs) were defined as AEs that occurred after the participant received first dose of study treatment or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment until 21 days after the date and time of last dose of study drug.
A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in the Reported AE section.
|
Baseline up to Week 12
|
|
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Induction Period
Tidsramme: Baseline up to Week 12
|
SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition.
A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in the Reported AE section.
|
Baseline up to Week 12
|
|
Number of Participants With Clinical Remission Per MMS at Week 12
Tidsramme: Week 12
|
Clinical Remission per MMS was defined as achieving MMS <=2, with RBS =0, SFS <=1 and not greater than baseline, and ES <=1. The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES), each of which ranges from 0 (normal) to 3 (severe disease). A lower MMS indicates better health status. |
Week 12
|
|
Number of Participants With MMS <=2 at Week 12
Tidsramme: Week 12
|
The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES), each of which ranges from 0 (normal) to 3 (severe disease).
A lower MMS indicates better health status.
|
Week 12
|
|
Number of Participants With Robarts Histopathology Index (RHI) Score <=3 at Week 12
Tidsramme: Week 12
|
The Robarts Histopathology Index (RHI) score is used to assess the disease severity.
The RHI is defined as the sum of four weighted items from Geboes: Grade 1: lamina propria chronic inflammation; Grade 2B: lamina propria neutrophils; Grade 3: epithelial neutrophils; Grade 5: surface epithelial injury.
Total RHI score ranges from 0 (no disease activity) to 33 (severe disease activity) with a higher score indicating more severity.
|
Week 12
|
|
Number of Participants With Clinical Response Per MMS at Week 12
Tidsramme: Baseline, Week 12
|
Clinical Response was defined as >=2 Points and >=30% decrease from baseline in MMS with >=1 point decrease in RBS or RBS <=1. The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES) each of which ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. |
Baseline, Week 12
|
|
Number of Participants With Endoscopic Response at Week 12
Tidsramme: Week 12
|
Endoscopic Response was defined as ES <=1. The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. |
Week 12
|
|
Number of Participants With Endoscopic Remission at Week 12
Tidsramme: Week 12
|
Endoscopic Remission was defined as ES =0. The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. |
Week 12
|
|
Number of Participants With Endoscopic-histologic Mucosal Improvement at Week 12
Tidsramme: Week 12
|
Endoscopic-histologic Mucosal Improvement was defined as ES <=1 and Geboes score <2.0. The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. The Geboes scoring system is a stepwise ordinal grading system for histological assessment of disease severity in UC. The Geboes score includes 7 histological items (Grade 0 Grade 5) with a total score summed to a continuous variable, ranging from 0 to 22. Lower Geboes scores indicate better health status. |
Week 12
|
|
Number of Participants With Histologic Endoscopic Mucosal Improvement (HEMI) at Week 12
Tidsramme: Week 12
|
HEMI was defined as ES <=1 and Geboes score <3.1. The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. The Geboes scoring system is a stepwise ordinal grading system for histological assessment of disease severity in UC. The Geboes score includes 7 histological items (Grade 0 Grade 5) with a total score summed to a continuous variable, ranging from 0 to 22. Lower Geboes scores indicate better health status. |
Week 12
|
|
Number of Participants With Histologic Endoscopic Mucosal Remission (HEMR) at Week 12
Tidsramme: Week 12
|
HEMR was defined as ES = 0 and Geboes score <2.0. The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. The Geboes scoring system is a stepwise ordinal grading system for histological assessment of disease severity in UC. The Geboes score includes 7 histological items (Grade 0 Grade 5) with a total score summed to a continuous variable, ranging from 0 to 22. Lower Geboes scores indicate better health status. |
Week 12
|
|
Number of Participants With Symptomatic Remission at Week 12
Tidsramme: Baseline, Week 12
|
Symptomatic remission was defined as RBS = 0 and (i) SFS = 0 or (ii) SFS = 1 with baseline SFS >2, at Week 12. The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES) each of which ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. |
Baseline, Week 12
|
|
Number of Participants With Clinical Response Per Partial MMS at Week 4
Tidsramme: Baseline, Week 4
|
Clinical response per partial MMS was defined as achieving >=1 points and >=30% decrease from baseline in partial MMS, with >=1 point decrease in RBS or RBS <=1. Partial MMS ranges from 0 (normal or inactive disease) to 6 (severe disease) and is calculated as the sum of 2 subscores (SFS and RBS), each of which ranges from 0 (normal) to 3 (severe disease). A lower partial MMS indicates better health status. |
Baseline, Week 4
|
|
Number of Participants With Abdominal Pain Score = 0 at Week 12
Tidsramme: Week 12
|
Participants rated their abdominal pain on a scale from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating more pain.
|
Week 12
|
|
Number of Participants With Rectal Urgency Score = 0 at Week 12
Tidsramme: Week 12
|
The rectal urgency score is based on the number of times participants must rush to the toilet to have a bowel movement.
The score ranges from 0 (2 or fewer events) to 10 (12 or more events), with higher scores representing more severe symptoms.
|
Week 12
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: AbbVie, AbbVie
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Tarmsykdommer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Kolonsykdommer
- Gastroenteritt
- Inflammatoriske tarmsykdommer
- Lymfesykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom
- Kolitt
- Hemic og lymfatiske sykdommer
- Kolitt, ulcerøs
- Lymfom, follikulær
- NX-13
Andre studie-ID-numre
- NX-13-201
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .