Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02325219 | An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis | PHASE3 | COMPLETED | 192 | — | — | Dec 19, 2014 | Feb 8, 2019 | May 22, 2020 | 27 | Japan |
| NCT01483599 | A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis | PHASE2 | COMPLETED | 293 | — | — | Nov 10, 2011 | Aug 5, 2013 | Aug 2, 2017 | 40 | United States, Belgium +3 |
| NCT01484587 | A Study of the Safety, Tolerability, Pharmacokinetics (What the Body Does to the Drug), and Pharmacodynamics (What the Drug Does to the Body) of CNTO 1959 Following a Single Subcutaneous (Under the Skin) Administration in Japanese Participants With Moderate to Severe Plaque Psoriasis | PHASE1 | COMPLETED | 24 | — | — | Aug 22, 2011 | Apr 11, 2013 | Sep 5, 2017 | 1 | Japan |
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema \[0 (no evidence of plaque) to 5 (dusky to deep red coloration)\], induration \[0 (no plaque evaluation) to 5 (marked plaque evaluation)\] and scaling \[0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)\]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Participants will receive subcutaneous injection of CNTO 1959 50 milligram (mg) and placebo 100 mg at Week 0, 4 and then every 8 weeks thereafter. |
| Group 2 | EXPERIMENTAL | Participants will receive subcutaneous injection of CNTO 1959 100 milligram (mg) and placebo 50 mg at Week 0, 4 and then every 8 weeks thereafter. |
| Group 3 | EXPERIMENTAL | Participants will receive subcutaneous injection of placebo 50 mg and 100 mg at Weeks 0, 4 and 12. At Week 16, participants will be randomized in sub-group 3a to receive either CNTO1959 50 mg and placebo 100 mg at Week 16, 20 and then every 8 weeks thereafter or sub-group 3b to receive CNTO 1959 100 mg and placebo 50 mg at Week 16, 20 and then every 8 weeks thereafter. |
| CNTO 1959 (5 mg) | EXPERIMENTAL | CNTO 1959 5 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40 |
| CNTO 1959 (15 mg) | EXPERIMENTAL | CNTO 1959 15 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40 |
| CNTO 1959 (50 mg) | EXPERIMENTAL | CNTO 1959 50 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40 |
| CNTO 1959 (100 mg) | EXPERIMENTAL | CNTO 1959 100 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40 |
| CNTO 1959 (200 mg) | EXPERIMENTAL | CNTO 1959 200 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40 |
| Adalimumab (approved psoriasis dosing) | ACTIVE_COMPARATOR | Adalimumab 80 mg at week 0 followed by 40 mg at week 1 and every second week through Week 39 (i.e., Weeks 3, 5, 7, etc.) |
| Placebo to CNTO 1959 (100 mg) | PLACEBO_COMPARATOR | Placebo at weeks 0, 4, and 8; then crossover to CNTO 1959 100 mg at Week 16, then every 8 weeks through Week 40 |
| 001 | EXPERIMENTAL | - |
| 002 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CNTO 1959 50 mg | DRUG | Participants will receive subcutaneous injection of CNTO 1959 50 mg. |
| CTNO 1959 100 mg | DRUG | Participants will receive subcutaneous injection of CNTO 1959 100 mg. |
| Placebo 50 mg | DRUG | Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg. |
| Placebo 100 mg | DRUG | Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg. |
| CNTO 1959 (5 mg) | DRUG | Subcutaneous (SC) injections |
| CNTO 1959 (15 mg) | DRUG | SC injections |
| CNTO 1959 (50 mg) | DRUG | SC injections |
| CNTO 1959 (100 mg) | DRUG | SC injections |
| CNTO 1959 (200 mg) | DRUG | SC injections |
| Adalimumab | DRUG | SC injections |
| Placebo | DRUG | SC injections |
| CNTO 1959 | DRUG | CNTO 1959: type=range, unit=mg, number=10, 30, 100, 300, form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks |
Inclusion Criteria: * Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months before Screening * Have a PASI greater than or equal to (\>=) 12 at Screening and at Baseline * Have an IGA \>= 3 at Screening and at Baseline * Have an involved body surface ar...