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A randomized, double-blind, placebo and positive controlled, single and multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CJM112 in chronic plaque-type psoriasis patients. This trial never made it to the Phase II part of this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJM112 | Experimental | CJM112 in different doses; single ascending and multiple ascending |
|
| Placebo | Placebo Comparator | Placebo to match |
|
| Secukinumab | Active Comparator | Active investigational drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJM112 | Biological | Monoclonal antibody |
| |
| Secukinumab |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety | Safety as assessed by the number of participants with adverse events as measured by laboratory parameters, vital signs, electrocardiogram and the collection of serious and non-serious adverse events. | 19 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) | 19 weeks | |
| Total CJM112 Concentrations in Serum | Measurement of drug levels in the blood of treated patients. | 19 weeks |
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Inclusion Criteria:
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, using highly effective methods of contraception during dosing and for 5 times the terminal half-life of study treatment.
• Male subjects must agree to comply with two highly effective contraceptive methods
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Anniston | Alabama | 36207 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CCJM112X2101 from the Novartis Trial Results database | View source |
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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| Biological |
Monoclonal antibody |
|
|
| Placebo | Other | Liquid for subcutaneous injection without active drug. |
|
| Concentration of anti-CJM112 Antibodies in Serum | Assessment of the ability of the compound to evoke an immune response. Assessed in blood of treated patients. | 19 weeks |
| Anaheim |
| California |
| 92801 |
| United States |
| Novartis Investigative Site | Encino | California | 91436 | United States |
| Novartis Investigative Site | North Hollywood | California | 91606 | United States |
| Novartis Investigative Site | Miami | Florida | 33136 | United States |
| Novartis Investigative Site | Miami | Florida | 33175 | United States |
| Novartis Investigative Site | Orlando | Florida | 32809 | United States |
| Novartis Investigative Site | Tampa | Florida | 33609 | United States |
| Novartis Investigative Site | Normal | Illinois | 61761 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46256 | United States |
| Novartis Investigative Site | Overland Park | Kansas | 66211 | United States |
| Novartis Investigative Site | Crowley | Louisiana | 70526 | United States |
| Novartis Investigative Site | Raleigh | North Carolina | 27612 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45255 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73112 | United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19103 | United States |
| Novartis Investigative Site | Austin | Texas | 78759 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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