Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CNTO 1959 · 4 trials · 2 indications
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.
The Palmoplantar Pustulosis Severity Index (PPSI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity.
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. |
| Placebo | PLACEBO_COMPARATOR | - |
| CNTO 1959 | EXPERIMENTAL | - |
| 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. |
| Placebo | DRUG | Placebo, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4 |
| CNTO 1959 | DRUG | CNTO 1959 200 mg, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4 |
| 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 |
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...
CNTO 1959 is an investigational small molecule being studied for the treatment of palmoplantar pustulosis and psoriasis, specifically moderate to severe plaque-type psoriasis. It is being developed by Johnson & Johnson for dermatology indications.
CNTO 1959 is a human anti-IL-23 monoclonal antibody, meaning it targets interleukin-23 (IL-23). By binding to IL-23, it is designed to modulate the immune response involved in inflammatory skin conditions like psoriasis and palmoplantar pustulosis.
CNTO 1959 is being developed by Johnson & Johnson, which trades under the ticker JNJ on the stock exchange. The company is conducting clinical trials to evaluate the drug's safety and efficacy in dermatology indications.
CNTO 1959 has completed Phase 1, Phase 2, and Phase 3 clinical trials. All trials are completed, with no active trials currently ongoing. The drug remains investigational and has not been reported as FDA approved.
CNTO 1959 has been studied in three completed trials: NCT01483599 (Phase 2, moderate to severe plaque psoriasis, 293 participants), NCT01484587 (Phase 1, Japanese participants with psoriasis, 24 participants), and NCT01845987 (Phase 2, palmoplantar pustulosis, 49 participants). A fourth trial, NCT02325219, is a Phase 3 study in Japanese participants with plaque psoriasis.
Yes, CNTO 1959 is also known as guselkumab. A clinical trial titled 'An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis' confirms that CNTO 1959 and guselkumab refer to the same drug.