| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00873860 | Study to Evaluate the Safety and Efficacy of CAT-354 | PHASE2 | COMPLETED | 357 | — | — | Jun 1, 2009 | Aug 1, 2010 | Mar 24, 2017 | 57 | Bulgaria, Germany +3 |
| NCT00638989 | A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354 | PHASE1 | COMPLETED | 30 | — | — | Apr 11, 2008 | Jun 7, 2008 | May 4, 2017 | 1 | United States |
Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score.
Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was assessed by the geometric least-square means ratios of subcutaneous to intravenous dose-normalized area under the serum concentration-time curve from time zero to infinity (AUC \[0 - infinity\]/Dose). AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 150 mg | EXPERIMENTAL | CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 300 mg | EXPERIMENTAL | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 600 mg | EXPERIMENTAL | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 150 mg (intravenous) | EXPERIMENTAL | A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. |
| CAT-354 150 mg (subcutaneous) | EXPERIMENTAL | A single dose of CAT-354 150 mg injection subcutaneously on Day 0. |
| CAT-354 300 mg (subcutaneous) | EXPERIMENTAL | A single dose of CAT-354 300 mg injection subcutaneously on Day 0. |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 150 mg | BIOLOGICAL | CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 300 mg | BIOLOGICAL | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 600 mg | BIOLOGICAL | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 150 mg (intravenous) | BIOLOGICAL | A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. |
| CAT-354 150 mg (subcutaneous) | BIOLOGICAL | A single dose of CAT-354 150 mg injection subcutaneously on Day 0. |
| CAT-354 300 mg (subcutaneous) | BIOLOGICAL | A single dose of CAT-354 300 mg injection subcutaneously on Day 0. |
Inclusion Criteria: * Male or female subjects * Age 18 to 65 years at the time of Screening * Subjects must have a body mass index (BMI) between 18 and 40 kilogram per square meter (kg/m\^2) * Written informed consent obtained from the subject prior to performing any protocol related procedures, in...