A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis

PHASE1CompletedINTERVENTIONAL
Enrollment

181

Participants

Timeline

Start Date

September 29, 2016

Primary Completion Date

February 4, 2019

Study Completion Date

October 2, 2019

Conditions
Crohn's DiseaseUlcerative Colitis (Part 2 Only)
Interventions
BIOLOGICAL

CT-P13

CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks (Part 1)

BIOLOGICAL

CT-P13

CT-P13 (120 mg) by single SC injection every 2 weeks (Part 1)

BIOLOGICAL

CT-P13

CT-P13 (180 mg) by double SC 90 mg injections every 2 weeks (Part 1)

BIOLOGICAL

CT-P13

CT-P13 (240 mg) by double SC 120 mg injections every 2 weeks (Part 1)

BIOLOGICAL

CT-P13

CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 6 (Part 2)

BIOLOGICAL

CT-P13

CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks up to Week 22. From Week 30, CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 30 (Part 2)

Trial Locations (1)

42415

Yeungnam University Hospital, Daegu

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celltrion

INDUSTRY

NCT02883452 - A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis | Biotech Hunter | Biotech Hunter