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- Klinische proef NCT01612039
Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis
A Phase 2, Randomized, Double-Blind, Parallel, Placebo-Controlled, Proof-of-Concept Study to Assess the Efficacy, Safety, and Tolerability of ASP3291 in Patients With Active Ulcerative Colitis
This is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled study. Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis will be randomized to double blind treatment of either 1,000 mg twice daily (b.i.d.) ASP3291 (2,000 mg/d) or matching placebo in a 1:1 ratio for 8 weeks.
The study hypothesis is that treatment with ASP3291 compared to placebo will improve a patient's ulcerative colitis endoscopic score from baseline to Week 8.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Documented diagnosis of ulcerative colitis by endoscopy and histology consistent with diagnosis
- Must be able to provide informed consent
- Has a Modified Baron Score of at least 2 (as determined by the investigator) at 15 cm or more from the anal verge as assessed during the screening period
- Has an Ulcerative Colitis Clinical Score (UCCS) of at least 4, with a stool frequency and rectal bleeding score of at least 1 as assessed during the screening period
- If female, is at least 2 years postmenopausal, surgically sterile per documentation provided by a medical professional, agrees to sexual abstinence, or uses two approved highly effective methods of birth control during the study period and for 30 days after the last dose of study drug
- If male, agrees to sexual abstinence or to use two highly effective methods of birth control during the study period and for 90 days after last dose; agrees to not donate sperm during the study period and for 90 days after last dose
- Willing and able to comply with the study requirements
Exclusion Criteria:
- Has a history of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the investigator's opinion, would preclude participation in the study
Has severe Ulcerative Colitis as defined by an average bloody stool frequency of >6 per day and at least one of the following:
- Resting heart rate >90 bpm
- Oral temperature of >38°C (>100.4°F)
- Hemoglobin of <10.5 g/dL
- Has has undergone previous resective colonic surgery
- Has a significant or immediate risk for toxic megacolon
- Has previous diagnosis with Crohn's disease, indeterminate colitis, microscopic colitis or acute diverticulitis based on medical history
- Has an extension of disease limited to ulcerative proctitis (i.e., disease extension less than 15 cm from the anal verge)
- Has an active peptic ulcer disease based on medical history
- Shows a stool culture positive for enteric pathogens during the screening period
- Had previous treatment with tumor necrosis factor-α (TNF α) inhibitors
- Had treatment with rectal corticosteroid within 2 weeks before Day -2
- Has active liver disease or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN) at screening
- Has an estimated glomerular filtration rate (using Cockroft-Gault formula corrected for body surface area) of <60 mL/min at screening
- Known history of human immunodeficiency virus antibody
- History of severe allergic or anaphylactic reactions requiring medical attention
- Has participated in another investigational study within 30 days before Visit 3
- History of drug or alcohol abuse in the past 2 years
- Has previously participated in a study with ASP3291
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Placebo-vergelijker: Placebo
|
Bijpassende placebotabletten
|
Experimenteel: ASP3291
|
Tablet, 1,000 mg (four 250-mg tablets), twice a day, 8 weeks
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Change from baseline (Visit 2) to Week 8 (Visit 7) in Modified Baron Score
Tijdsspanne: Baseline to Week 8
|
Baseline to Week 8
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Proportion of subjects with Modified Baron Score of 0 or 1 at Week 8 (Visit 7)
Tijdsspanne: Week 8
|
Week 8
|
Change in Ulcerative Colitis Clinical Score of >3
Tijdsspanne: Basline to Week 8
|
Basline to Week 8
|
Ulcerative Colitis Clinical Score stool frequency and rectal bleeding score of 0
Tijdsspanne: Week 8
|
Week 8
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Robert Schinagl, Ph.D., Drais Pharmaceuticals, Inc.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 3291-CL-0004
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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Klinische onderzoeken op Colitis ulcerosa
-
Maastricht University Medical CenterVoltooidLymfatische colitis | Microscopische colitis | Collagene colitisNederland
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Technische Universität DresdenDr. Falk Pharma GmbHVoltooid
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Dr. Falk Pharma GmbHVoltooid
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Dr. Falk Pharma GmbHThe Swedish Organization for Studies on Inflammatory Bowel DiseaseVoltooidInductie en behoud van remissie van collagene colitisDuitsland, Zweden
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Karolinska University HospitalOnbekendLymfatische colitis | Collagene colitis | Chronische diarreeZweden
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Dr. Falk Pharma GmbHVoltooidCollagene colitisDuitsland
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Technische Universität DresdenAstraZenecaVoltooid
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Dr. Falk Pharma GmbHVoltooidOnvolledige microscopische colitisDuitsland, Zweden
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Meharry Medical CollegeNog niet aan het wervenInflammatoire darmziekten | Colitis ulcerosa | Crohn colitis | Onbepaalde colitisVerenigde Staten
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Ferring PharmaceuticalsVoltooidActieve colitis ulcerosa | Remissie van colitis ulcerosaCanada
Klinische onderzoeken op ASP3291
-
Telsar Pharma Inc.VoltooidColitis ulcerosaVerenigde Staten