Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease

Phase 2

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: PF-00547659 SC injection

• Registration Number: NCT01276509
• Lead Sponsor: Shire

Brief Summary

Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Study Start: 2011-04-06
• Primary Completion: 2014-02-07
• Disposition First Submitted: 2015-02-08
• Disposition First Submitted QC: 2015-02-08
• Disposition First Posted: 2015-02-25
• Study Completion: 2015-10-09
• Results First Submitted: 2016-10-05
• Results First Submitted QC: 2017-03-02
• Results First Posted: 2017-04-13
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

Inclusion Criteria

• Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants (AZA, 6-MP, and/or MTX).
• hsCRP greater than 3mg/L
• Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening

Exclusion Criteria

• Pregnant or breast feeding
• Short bowel syndrome due to multiple small bowel resections
• Presence of a stoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo-SC Injection	PF-00547659 SC injection	Placebo delivered SC, 3 doses separated by 4 weeks.
Drug Dose level 2-SC injection	PF-00547659 SC injection	Drug dose level 2 delievered SC, 3 doses separated by 4 weeks.
Drug Dose level 1- SC injection	PF-00547659 SC injection	Drug dose level 1 delivered SC, 3 doses separated by 4 weeks.
Drug Dose level 3- SC injection	PF-00547659 SC injection	Drug dose level 3 delivered SC, 3 doses separated by 4 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate	Week 8 and week 12	Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo	Week 0-12	Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported.
The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax)	Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252	The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Tmax is time for Cmax.
Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo	Week 0-12	Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group.
Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission	Weeks 8 and week 12	Percentage of participants with a CDAI remission (defined as a CDAI reduction to \<150 points).
The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)	Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252	The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time.
Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time	Week 2, 4, 6, 8, 10 and 12	Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported.
Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer	Week 2, 4, 6, 8, 10 and 12	Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported.
The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf)	Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252	The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Thalf is terminal half life.
Immunogenicity Assessment of Anti-drug Antibodies (ADAs)	Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36	Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659
The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau)	Day 1, 14, and 28	The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks)
The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax)	Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252	The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Cmax is maximum observed concentration.
The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F)	Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252	The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. CL/F is apparent clearance.

Trial Locations

Locations (137)

Clopton Clinic; 🇺🇸 Jonesboro, Arkansas, United States

Gastroenterology Specialists of Arkansas; 🇺🇸 Jonesboro, Arkansas, United States

Little Rock Diagnostic Clinic, P.A.; 🇺🇸 Little Rock, Arkansas, United States

UCSD Medical Center-Thornton Hospital; 🇺🇸 La Jolla, California, United States

Community Clinical Trials; 🇺🇸 Orange, California, United States

Gastro Diagnostics; 🇺🇸 Orange, California, United States

Inland Gastroenterology Medical Associates, Inc.; 🇺🇸 Redlands, California, United States

BioMark Research Inc.; 🇺🇸 Whittier, California, United States

Clinical Research of the Rockies; 🇺🇸 Lafayette, Colorado, United States

Rocky Mountain Gastroenterology Associates; 🇺🇸 Thornton, Colorado, United States

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