Phase 2a Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Ulcerative Colitis

NCT02888379 | Completed Phase 2

• 1 other identifier: TOP1288-TV-02
• Study Type: interventional
• Target: 77
• Locations: 8 countries
• Sites: 28

Brief Summary

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Efficacy as measured by the Mayo Clinic modified endoscopic subscore

  After 4 consecutive weeks of daily bedtime treatment

Secondary Outcomes (8)

• Safety as measured by adverse events

  To 1 week after the last dose

• Safety as measured by vital signs

  To 1 week after the last dose

• Safety as measured by ECGs

  To 1 week after the last dose

• Safety as measured by clinical laboratory tests

  To 1 week after the last dose

• Efficacy as measured by Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score

  After 4 consecutive weeks of daily bedtime treatment

Study Arms (2)

TOP1288 200 mg Rectal Solution

EXPERIMENTAL

TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks

Drug: TOP1288

Placebo Rectal Solution

PLACEBO COMPARATOR

Placebo (for TOP1288) Rectal Solution Once Daily for 4 Weeks

Drug: Placebo (for TOP1288)

Interventions

TOP1288 DRUG

TOP1288 200 mg Rectal Solution

Placebo (for TOP1288) DRUG

Placebo Rectal Solution

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of UC of at least 3 months duration
• Active UC with a Partial Mayo Clinic Score of 4 to 8 at randomization

You may not qualify if:

• Receiving any rectally administered medication
• Use of biologic agents within 3 months prior to Screening endoscopy
• Use of IV corticosteroids within 4 weeks prior to Screening endoscopy
• Use of oral corticosteroids at a dose \>30 mg/day (or budesonide \>9 mg/day).
• Patients who have started receiving immune suppressants within 3 months of the Screening endoscopy should not be included.
• Known or suspected pancolitis (unless on oral 5-ASA, steroids or permitted immunomodulators)
• Known or suspected Crohn's disease, indeterminate colitis, microscopic colitis, ischaemic colitis, or radiation-induced colitis, based on medical history, endoscopy, and/or histological findings
• Extensive (\>50%) colonic resection or colectomy, or prior history of toxic megacolon within 3 months of Screening
• Patient has active serious infection (e.g., sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalisation or requiring parenteral antibiotic treatment) within 6 weeks prior to IMP administration
• Patients testing positive of Clostridium difficile toxin or confirmed with bacterial or parasitical GI infections at Screening

Sponsors & Collaborators

• Topivert Pharma Ltd: lead

Study Sites (28)

Unknown Facility

Plovdiv, Bulgaria

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Sofia, Bulgaria

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Brno, Czechia

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Litoměřice, Czechia

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Olomouc, Czechia

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Prague, Czechia

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Budapest, Hungary

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Gyöngyös, Hungary

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Győr, Hungary

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Gyula, Hungary

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Szeged, Hungary

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Székesfehérvár, Hungary

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Vác, Hungary

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Daugavpils, Latvia

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Riga, Latvia

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Kaunas, Lithuania

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Bydgoszcz, Poland

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Knurów, Poland

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Skierniewice, Poland

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Sopot, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Kherson, Ukraine

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Kyiv, Ukraine

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Odesa, Ukraine

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Temopil, Ukraine

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Zaporizhzhia, Ukraine

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London, United Kingdom

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Simon Travis, FRCP

  Oxford University Hospitals Trust, John Radcliffe Hospital, Oxford, UK,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 5, 2016
• Study Start: September 1, 2016
• Primary Completion: June 28, 2017
• Study Completion: June 28, 2017
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

BU (2); UA (5); PL (6); HU (7); CZ (4); LI (1); GB (1); LA (2)