Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0142-0002 · 2 trials · 2 indications
DAS28-CRP=0.56×sqrt(tender joints \[count:1-28\])+0.28×sqrt(swollen joints \[count:1-28\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \[100=most severe\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.
Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.
| Arm | Type | Description |
|---|---|---|
| 4.0 mg/kg | EXPERIMENTAL | Subjects received a single dose of 4 mg/kg NNC0142-0002 |
| Placebo | PLACEBO_COMPARATOR | Subjects received a single dose of placebo |
| SD 0.0002 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 0.0002 mg/kg |
| SD 0.0012 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 0.0012 mg/kg |
| SD 0.007 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 0.007 mg/kg |
| SD 0.035 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 0.035 mg/kg |
| SD 0.175 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 0.175 mg/kg |
| SD 0.7 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 0.7 mg/kg |
| SD 2.5 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 2.5 mg/kg |
| SD 7.5 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 7.5 mg/kg |
| SD Placebo | EXPERIMENTAL | Subjects were injected once with placebo |
| MD 0.02 mg/kg | EXPERIMENTAL | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg |
| MD 0.3 mg/kg | EXPERIMENTAL | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg |
| MD 1.0 mg/kg | EXPERIMENTAL | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg |
| MD 1.6 mg/kg | EXPERIMENTAL | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg |
| MD 4.0 mg/kg | EXPERIMENTAL | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg |
| MD Placebo | EXPERIMENTAL | Subjects were injected biweekly four times with placebo |
| Name | Type | Description |
|---|---|---|
| NNC0142-0002 | DRUG | A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin). |
| placebo | DRUG | A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin). |
Inclusion Criteria: * A diagnosis of RA meeting the American College of Rheumatology 1987 (ACR1987) criteria, obtained at least three months prior to dosing with the trial product * Subjects with active RA having a Disease Activity Score (DAS28-CRP) of 4.5 or more, at least five tender and five swo...
NNC0142-0002 is an investigational small molecule being developed for inflammation, specifically studied in patients with rheumatoid arthritis. It is in Phase 2 clinical development and is not yet approved by the FDA. The drug is being evaluated for its efficacy in reducing inflammation associated with rheumatoid arthritis.
NNC0142-0002 is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with rheumatoid arthritis, a chronic inflammatory condition.
NNC0142-0002 is in Phase 2 clinical development. It has completed two clinical trials, including a Phase 1 first-in-man study and a Phase 2 efficacy study, both in patients with rheumatoid arthritis. The drug remains investigational and has not received FDA approval.
NNC0142-0002 has been studied in two completed clinical trials. NCT00927927 was a Phase 1 first-in-man trial in 65 patients with rheumatoid arthritis in Germany. NCT01181050 was a Phase 2 efficacy trial in 63 patients across Germany, Russia, and Ukraine. Both trials were randomized, double-blind, and controlled.
No alternative names for NNC0142-0002 have been identified. The drug is referred to solely by its code name NNC0142-0002 in clinical trial registrations and development documentation.