Resumen

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).

Descripción detallada

Study M14-675 consists of 2 parts, Part 1 and Part 2. Part 1 is a randomized, double-blind, placebo-controlled 8-week induction period. Part 2 is an open-label, 8-week extended treatment period for participants who did not achieve clinical response at Week 8 in Part 1. Eligible participants are randomized in a 2:1 ratio to one of the two treatment groups (upadacitinib 45 mg or matching placebo) for 8 weeks. The randomization is stratified by biologic inadequate responder (bio-IR) status (bio-IR vs non-bio-IR), corticosteroid use (yes or no), and Adapted Mayo score (≤ 7 or \> 7) at Baseline. Within bio-IR, the randomization is further stratified by number of prior biologic treatments (≤ 1 or \> 1). Within non-bio-IR, the randomization is further stratified by previous biologic use (yes or no). Participants who achieve clinical response defined by Adapted Mayo Score at Week 8 or Week 16 and do not meet any study discontinuation criteria are eligible to enroll into Study M14-234 Substudy 3 (NCT02819635; 52-week maintenance study) or Study M14-533 Cohort 1 (NCT03006068; long-term follow-up study).

Elegibilidad

Edad mínima: 16 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

\- Male or female participants ≥ 16 and ≤ 75 years of age at Baseline Note: Adolescent participants at the age of 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authorities.
Note: Adolescent participants at the age of 16 or 17 years old must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at the Screening Visit.
Diagnosis of Ulcerative Colitis (UC) for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3.
Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.
Note: Participants who have had inadequate response, loss of response to conventional therapy but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease), and must meet criteria for inadequate response, loss of response, or intolerance as defined above.
Female Participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit.
If female, participant must meet the contraception recommendation criteria.

Criterios de exclusión

Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).
Current diagnosis of fulminant colitis and/or toxic megacolon.
Participant with disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy.
Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline.
Participant who received azathioprine or 6-mercaptopurine (6-MP) within 10 days of Baseline.
Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
Screening laboratory and other analyses show any prespecified abnormal hematologic results.

Ubicaciones

Cardio Alem /ID# 211282

San Isidro, Buenos Aires, Argentina

Mautalen Salud e Investigacion /ID# 206033

Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina

Hospital Britanico de Buenos Aires /ID# 209497

Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina

Gedyt /ID# 210017

Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina

Hospital Privado Univesitario /ID# 206030

Córdoba, Argentina

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Placebo

Upadacitinib

Ubicaciones

Cardio Alem /ID# 211282

Mautalen Salud e Investigacion /ID# 206033

Hospital Britanico de Buenos Aires /ID# 209497

Gedyt /ID# 210017

Hospital Privado Univesitario /ID# 206030

Patrocinadores