NCT02510937

Safety and PK Study of CC-90001 in Subjects With Pulmonary Fibrosis

A Phase 1b, Multicenter, Open-label, Staggered-dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of CC-90001 for 3 Months in Patients With Pulmonary Fibrosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Participation in the study will last for 3months, with a 1 month screening phase.

Detailed description

This is an open-label, staggered dose-escalation, cohort expansion study that will enroll subjects at multiple study sites in the United States of America (USA) and Australia. The study will consist of two treatment arms: * Low dose (100 mg) CC-90001 administered orally once daily (QD) for 12 continuous weeks. * High dose (200 mg) CC-90001 administered orally QD for 12 continuous weeks. The high dose (200 mg) CC-90001 arm will not start until at least three subjects complete a minimum of 2 weeks of low-dose CC 90001 and the low dose treatment arm is determined not to meet the study dose escalation stopping criteria (Figure 2). Each subject will participate in a Screening (up to 4 weeks prior to treatment), a 12 week Treatment Phase, and a 4-week Follow-up visit. Subjects will be screened for eligibility. Subjects who meet all of the inclusion criteria and none of the exclusion criteria at Screening will return to the study site on Day 1 for assessments and to begin administration of a QD dose of CC 90001, according to the dose level in which the subject is enrolled. Three subjects will initially be enrolled to receive low dose CC-90001 (100 mg QD), and will be evaluated for all scheduled assessments through 12 weeks of treatment. Once a total of three subjects have completed the Week 2 visit, a decision to continue the study at the high dose level (200 mg QD) will be determined. If the criteria for escalation to the high dose (CC-90001 200 mg QD) are met, the low dose (CC-90001 100 mg QD) subjects will remain on low dose (CC-90001 100 mg QD) and six additional subjects will be enrolled at the high dose level (CC-90001 200 mg QD). If one of the three subjects at the low dose (CC-90001 100 mg QD) experiences an event that meets the individual subject dose stopping criteria, another three subjects will be enrolled in the low dose arm. Dose escalation to the high dose (CC-90001 200 mg QD) will not occur if two or more of the six subjects meet the individual subject dose stopping criteria. All subjects (low and high dose) will remain on CC-90001 for a total of 12 weeks unless an individual subject experiences an event that meets any of the individual subject stopping criteria. In addition, the dose of CC-90001 may be reduced CC-90001 200 mg QD to CC-90001 100 mg QD) for an individual who meets any of the individual subject dose reduction criteria. If two or more subjects in the high dose (CC-90001 200 mg QD) arm experience an event that meets the individual stopping criteria, the 100 mg QD dose arm may be repeated in three additional subjects, or the study may be stopped. Study visits will occur at Screening, Day 1, and Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16 (a Follow-up visit). Blood and urine samples will be collected at specified times for clinical safety laboratory assessments, pharmacokinetic analysis (how the drug affects the body), and pharmacodynamic analysis (how the body affects the drug). Safety will be monitored throughout the study.

Conditions

• Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	CC-90001

Timeline

• Start date: 2015-08-05
• Primary completion: 2017-02-06
• Completion: 2017-02-06
• First posted: 2015-07-29
• Last updated: 2017-04-04

Locations

6 sites across 2 countries: United States, Australia