A Pilot Study of FFP104 in Subjects With Crohn's Disease

NCT02465944 | Unknown Phase 1 DMC

• 2 other identifiers: FFP104-0022015-001678-17
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

Brief Summary

This study will be conducted to evaluate the safety, tolerability and efficacy of intravenously administered FFP104 or placebo over 15 days (3 total doses) in subjects with moderate to severely active Crohn's Disease

Conditions

Crohn's Disease

Keywords

inflammation

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability will be assessed through clinical laboratory tests, vital signs, physical exams, and adverse event assessments

  Up to 84 days

Secondary Outcomes (14)

• Proportion of subjects achieving clinical response (decrease of Crohn's Disease Activity Index (CDAI) score by ≥100 points from baseline)

  Days 0, 7, 14, 28, 42 and 84

• Proportion of subjects achieving clinical remission (attainment of absolute CDAI score of 150 points or less from baseline)

  Days 0, 7, 14, 28, 42 and 84

• Proportion of subjects achieving partial response (decrease of CDAI score by >70 points from baseline)

  Days 0, 7, 14, 28, 42 and 84

• Difference in CDAI score between FFP104 treated subjects and placebo subjects in each arm of the study

  Days 0, 7, 14, 28, 42 and 84

• Time to response (decrease in CDAI score by >100 points)

  Days 0, 7, 14, 28, 42 and 84

Study Arms (3)

FFP104 - 2.5 mg/kg

EXPERIMENTAL

FFP104

Drug: FFP104

FFP104 - 5.0 mg/kg

EXPERIMENTAL

FFP104

Drug: FFP104

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

FFP104 DRUG

Three intravenous infusions of FFP104 over 15 days (d0, d7 and d14)

FFP104 - 2.5 mg/kg; FFP104 - 5.0 mg/kg

Placebo DRUG

Three intravenous infusions of 0.9% Saline over 15 days (d0, d7 and d14)

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects will be entered into this study only if they meet all of the following criteria:
• Willing and able to provide written informed consent.
• Willing and able to comply with all study procedures and visits.
• Male or female aged between 18 and 75 years, inclusive.
• Body Mass Index (BMI) between 18-35 kg/m2.
• Clinical diagnosis of Crohn's disease involving the colon and/or ileum for at least 3 months from Screening confirmed by radiological, endoscopic or histological evidence.
• Active Crohn's disease defined as a Crohn's Disease Activity Index (CDAI) score from 220 and 450, inclusive, at Screening.
• Active inflammatory disease as defined by Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8 (as determined by a Central Blinded Reader) at Screening.
• Tumor Necrosis Factor (TNF)-naïve or previously exposed to a single anti-TNF agent (such as infliximab, adalimumab or certolizumab pegol) with treatment discontinued at least 8 weeks prior to Screening due to inadequate response, loss of response or intolerance as judged by the Investigator.
• Must have adequate renal and hepatic function as adjudged by the Investigator.
• In good health (other than Crohn's disease) as evidenced by medical history and physical examination.

You may not qualify if:

• Subjects will be entered into this study only if they meet none of the following criteria:
• Subjects who are pregnant, breastfeeding, or of child-bearing potential and not using a medically accepted form of contraception.
• Presence of fistulas, ileostomies, colostomies or rectal pouches or history of proctocolectomy or total colectomy. Subject has an ostomy or ileoanal pouch (subjects with a previous ileorectal anastomosis are not excluded).
• Subject has short bowel syndrome as determined by the Investigator.
• History of evidence of colonic mucosal dysplasia.
• Subject currently has a significant mechanical obstruction (stenosis).
• Subject has a current diagnosis of ulcerative or indeterminate colitis.
• Immunization with a live vaccine within 4 weeks of Screening, with the exception of influenza vaccine and no planned immunizations within the period of the study.
• Active or latent tuberculosis (TB) or tuberculosis infection; TB assessment and prophylaxis will be performed as per local biologicals regulations and guidelines.
• Subjects with a history of or ongoing chronic or recurrent infectious disease within the 12 months prior to Screening.
• Positive stool culture for Clostridium within the last 6 months prior to Screening.
• Use of prohibited medications/procedures, including;
• Concomitant corticosteroids doses exceeding 20 mg/day of prednisone (equivalent)
• Concomitant use of budesonide
• Concomitant use of anti-TNF therapy

Sponsors & Collaborators

• Fast Forward Pharmaceuticals: lead

Study Sites (2)

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

RECRUITING

Erasmus Medical Center

Rotterdam, 3015CE, Netherlands

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Inflammation

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: May 18, 2015
• First Posted: June 9, 2015
• Study Start: January 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 24, 2016

Record last verified: 2016-08

Locations

BE (1); NL (1)