Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis

Phase 2TerminatedNCT05785715

AbbVie81 enrolled

Overview

Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).

This is a randomized, multicenter, double-blind, placebo-controlled, multiple dose exploratory Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Ulcerative Colitis

Interventions

NX-13 250mgDRUG

NX-13 250mg tablet, plus 2 placebo tablets

NX-13 750mgDRUG

NX-13 250mg tablets times 3 to equal 750mg

NX-13 PlaceboDRUG

NX-13 Placebo tablets times 3 for blinding purposes

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult subjects aged 18 to 75 years (inclusive) * Diagnosis of UC ≥ 90 days before screening confirmed by histologic evidence * Active UC defined as a total Mayo Score (MMS) of ≥ 5 (inclusive) at baseline * ES ≥ 2 within 14 days prior to randomization * RBS ≥ 1. Exclusion Criteria: * Severe extensive colitis as evidenced by physician judgment that the participant is likely to require hospitalization for medical care or surgical intervention of any kind for UC (e.g., colectomy) within the 12 weeks after randomization; * Current evidence of fulminant colitis, toxic megacolon or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation * Diagnosis of Crohn's disease (CD) or indeterminate colitis, or the presence or history of a fistula consistent with CD * Diagnosis of microscopic colitis, ischemic colitis, or radiation colitis * Bacterial or parasitic pathogenic enteric infection;

Locations (35)

Outcomes

Primary Outcomes

Change From Baseline in Modified Mayo Score (MMS) 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 (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.

Time frame: Baseline, Week 12

Secondary Outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Induction Period

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.

Time frame: Baseline up to Week 12

Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Induction Period

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.

Time frame: Baseline up to Week 12

Number of Participants With Clinical Remission Per MMS at 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.

Data from ClinicalTrials.gov

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Miami Clinical Research

Miami, Florida, United States

Orlando Health, Inc.

Orlando, Florida, United States

GCP Clinical Research

Tampa, Florida, United States

Digestive Health Center of Michigan

Chesterfield, Michigan, United States

Clinical Research Institute of Michigan

Troy, Michigan, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Digestive Disease Specialist, Inc-INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, United States

Digestive Health Associates of Texas-GI Alliance Research-Garland

Garland, Texas, United States

Digestive Health Associates of Texas-GI Alliance

Mansfield, Texas, United States

Texas Digestive Disease Consultants-GI Alliance Research

Southlake, Texas, United States

...and 25 more locations

Number of Participants With MMS <=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). A lower MMS indicates better health status.

Time frame: Week 12

Number of Participants With Robarts Histopathology Index (RHI) Score <=3 at 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.

Time frame: Week 12

Number of Participants With Clinical Response Per MMS at 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.

Time frame: Baseline, Week 12

Number of Participants With Endoscopic Response at 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.

Time frame: Week 12

Number of Participants With Endoscopic Remission at 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.

Time frame: Week 12

Number of Participants With Endoscopic-histologic Mucosal Improvement at 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.

Time frame: Week 12

Number of Participants With Histologic Endoscopic Mucosal Improvement (HEMI) at 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.

Time frame: Week 12

Number of Participants With Histologic Endoscopic Mucosal Remission (HEMR) at 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.

Time frame: Week 12

Number of Participants With Symptomatic Remission at 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.

Time frame: Baseline, Week 12

Number of Participants With Clinical Response Per Partial MMS at 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.

Time frame: Baseline, Week 4

Number of Participants With Abdominal Pain Score = 0 at 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.

Time frame: Week 12

Number of Participants With Rectal Urgency Score = 0 at 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.

Time frame: Week 12