Undersøgelse til evaluering af den kliniske aktivitet og sikkerhed af Oral NX-13 ved moderat til svær colitis ulcerosa
Et randomiseret, dobbeltblindt, placebo-kontrolleret, multicenter fase 2-induktionsstudie med flere doser med langsigtet forlængelse til evaluering af den kliniske aktivitet og sikkerhed af oral NX-13 hos deltagere med moderat til svær colitis ulcerosa
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Leuven, Belgien
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg
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Florida
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Miami, Florida, Forenede Stater, 33155
- Miami Clinical Research
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Orlando, Florida, Forenede Stater, 32806
- Orlando Health, Inc.
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Tampa, Florida, Forenede Stater, 33609
- GCP Clinical Research
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Michigan
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Chesterfield, Michigan, Forenede Stater, 48047
- Digestive Health Center of Michigan
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Troy, Michigan, Forenede Stater, 48098
- Clinical Research Institute of Michigan
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine in St. Louis
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73112
- Digestive Disease Specialist, Inc-INTEGRIS Baptist Medical Center
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Texas
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Garland, Texas, Forenede Stater, 75044
- Digestive Health Associates of Texas-GI Alliance Research-Garland
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Mansfield, Texas, Forenede Stater, 76003
- Digestive Health Associates of Texas-GI Alliance
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Southlake, Texas, Forenede Stater, 76092
- Texas Digestive Disease Consultants-GI Alliance Research
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
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Milan, Italien
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
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Roma, Italien
- Azienda Ospedaliera - Universitaria Sant' Andrea
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Rozzano, Italien
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
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San Giovanni Rotondo, Italien
- IRCCS Fondazione Casa Sollievo della Sofferenza SG Rotondo
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Torino, Italien
- Azienda Ospedaliera Ordine Mauriziano Di Torino
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Bydgoszcz, Polen
- ClinSante - Ośrodek Badań Klinicznych w Bydgoszczy
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Bydgoszcz, Polen
- Przychodnia Vitamed NFZ
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Jelenia Góra, Polen
- Amicare Centrum Medyczne
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Katowice, Polen
- VITA LONGA Clinic - Katowice
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Krakow, Polen
- Krakowska Przychodnia FutureMeds
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Lodz, Polen
- Amicare Sp. z o.o. Sp.k.
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Opoczno, Polen
- Amicare Sp z o.o. S.K
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Opole, Polen
- Twoja Przychodnia Opolskie Centrum Medyczne
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Poznan, Polen
- RiverMED Poradnie Specjalistyczne Poznań
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Sopot, Polen
- Endoskopia Sp. z o.o.
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Szczecin, Polen
- Sonomed Sp. z o.o. Centrum Medyczne
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Szczecin, Polen
- Twoja Przychodnia Szczecińskie Centrum Medyczne
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Torun, Polen
- Torunskiego Centrum Gastrologii I Endoskopii - Gastromed
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Tychy, Polen
- H-T Centrum Medyczne
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Warsaw, Polen
- Office of Jaroslaw Kierkus, Dr N Med
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Wroclaw, Polen
- Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
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Wroclaw, Polen
- Zabobrze Centrum Medyczne
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Włocławek, Polen
- Centrum Diagnostyczno - Lecznicze Barska
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Voksne forsøgspersoner i alderen 18 til 75 år (inklusive)
- Diagnose af UC ≥ 90 dage før screening bekræftet af histologisk evidens
- Aktiv UC defineret som en total Mayo Score (MMS) på ≥ 5 (inklusive) ved baseline
- ES ≥ 2 inden for 14 dage før randomisering
- RBS ≥ 1.
Ekskluderingskriterier:
- Alvorlig omfattende colitis som dokumenteret af lægens vurdering af, at deltageren sandsynligvis vil kræve hospitalsindlæggelse for medicinsk behandling eller kirurgisk indgreb af enhver art for UC (f.eks. kolektomi) inden for 12 uger efter randomisering;
- Aktuelle tegn på fulminant colitis, toksisk megacolon eller nyere historie (inden for 6 måneder før screening) af toksisk megacolon eller tarmperforation
- Diagnose af Crohns sygdom (CD) eller ubestemt colitis, eller tilstedeværelsen eller historien om en fistel i overensstemmelse med CD
- Diagnose af mikroskopisk colitis, iskæmisk colitis eller strålingscolitis
- bakteriel eller parasitisk patogen enterisk infektion;
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: NX-13 250mg
Forsøgspersonerne vil tage undersøgelseslægemidlet ved at indtage tre tabletter om dagen, anbefalet på samme tidspunkt dagligt for konsistens.
Forsøgspersoner i en NX-13-gruppe vil modtage enten 250 mg eller 750 mg NX-13 i 3 tabletter, og forsøgspersoner i placebogruppen vil modtage matchende placebo.
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NX-13 250 mg tablet, plus 2 placebotabletter
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Eksperimentel: NX-13 750mg
Forsøgspersonerne vil tage undersøgelseslægemidlet ved at indtage tre tabletter om dagen, anbefalet på samme tidspunkt dagligt for konsistens.
Forsøgspersoner i en NX-13-gruppe vil modtage enten 250 mg eller 750 mg NX-13 i 3 tabletter, og forsøgspersoner i placebogruppen vil modtage matchende placebo.
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NX-13 250 mg tabletter gange 3 til 750 mg
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Placebo komparator: NX-13 placebo
Forsøgspersonerne vil tage undersøgelseslægemidlet ved at indtage tre tabletter om dagen, anbefalet på samme tidspunkt dagligt for konsistens.
Forsøgspersoner i en NX-13-gruppe vil modtage enten 250 mg eller 750 mg NX-13 i 3 tabletter, og forsøgspersoner i placebogruppen vil modtage matchende placebo.
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NX-13 Placebo-tabletter gange 3 til blændende formål
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change From Baseline in Modified Mayo Score (MMS) at Week 12
Tidsramme: Baseline, Week 12
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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.
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Baseline, Week 12
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Induction Period
Tidsramme: Baseline up to Week 12
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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.
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Baseline up to Week 12
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Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Induction Period
Tidsramme: Baseline up to Week 12
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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.
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Baseline up to Week 12
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Number of Participants With Clinical Remission Per MMS at Week 12
Tidsramme: Week 12
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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
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Number of Participants With MMS <=2 at Week 12
Tidsramme: Week 12
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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.
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Week 12
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Number of Participants With Robarts Histopathology Index (RHI) Score <=3 at Week 12
Tidsramme: Week 12
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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.
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Week 12
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Number of Participants With Clinical Response Per MMS at Week 12
Tidsramme: Baseline, Week 12
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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
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Number of Participants With Endoscopic Response at Week 12
Tidsramme: Week 12
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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
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Number of Participants With Endoscopic Remission at Week 12
Tidsramme: Week 12
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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
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Number of Participants With Endoscopic-histologic Mucosal Improvement at Week 12
Tidsramme: Week 12
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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
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Number of Participants With Histologic Endoscopic Mucosal Improvement (HEMI) at Week 12
Tidsramme: Week 12
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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
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Number of Participants With Histologic Endoscopic Mucosal Remission (HEMR) at Week 12
Tidsramme: Week 12
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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
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Number of Participants With Symptomatic Remission at Week 12
Tidsramme: Baseline, Week 12
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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
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Number of Participants With Clinical Response Per Partial MMS at Week 4
Tidsramme: Baseline, Week 4
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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
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Number of Participants With Abdominal Pain Score = 0 at Week 12
Tidsramme: Week 12
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Participants rated their abdominal pain on a scale from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating more pain.
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Week 12
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Number of Participants With Rectal Urgency Score = 0 at Week 12
Tidsramme: Week 12
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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.
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Week 12
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: AbbVie, AbbVie
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Tarmsygdomme
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Gastroenteritis
- Inflammatoriske tarmsygdomme
- Lymfesygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom
- Colitis
- Hemiske og lymfatiske sygdomme
- Colitis, Ulcerativ
- Lymfom, follikulært
- NX-13
Andre undersøgelses-id-numre
- NX-13-201
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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