Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as tofacitinib
Tofacitinib/g · 2 trials · 3 indications
The EASI quantifies the severity of a participant's atopic dermatitis based on both lesion severity and the percent of BSA affected. The EASI is a composite scoring by the atopic dermatitis clinical evaluator of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. What is reported is the percent change from baseline in EASI scores.
Clinical signs of plaque psoriasis (erythema \[E\], induration \[I\], and scaling \[S\]) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.
Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.
| Arm | Type | Description |
|---|---|---|
| Treatment group A | EXPERIMENTAL | - |
| Treatment B | PLACEBO_COMPARATOR | - |
| Treatment Group B | EXPERIMENTAL | - |
| Treatment Group C | PLACEBO_COMPARATOR | - |
| Treatment Group D | EXPERIMENTAL | - |
| Treatment Group E | EXPERIMENTAL | - |
| Treatment Group F | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Tofacitinib ointment 20mg/g | DRUG | Tofacitinib ointment 20mg/g twice daily (BID) for 4 weeks |
| Placebo ointment (Vehicle) | DRUG | Placebo ointment (vehicle) twice daily (BID) for 4 weeks |
| tofacitinib ointment 20 mg/g | DRUG | tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks |
| tofacitinib ointment 10 mg/g | DRUG | tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks |
Inclusion Criteria: * Have a clinical diagnosis of atopic dermatitis (also known as atopic eczema) for at least 6 months prior to Day 1 that has been clinically stable for at least 1 month prior to Day 1 and is confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka. * Have...
CP-690-550, also known as tofacitinib, is an investigational small molecule being studied for the treatment of psoriasis, juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It is in Phase 2 clinical development for these immunology indications.
CP-690-550 is a kinase inhibitor, belonging to the -tinib class of drugs. It targets kinases, which are enzymes involved in cell signaling pathways. By inhibiting these kinases, it modulates immune responses relevant to the autoimmune and inflammatory conditions it is being studied for.
CP-690-550 is being developed by Pfizer, Inc., a biopharmaceutical company. Pfizer is the sponsor of the clinical trials for this drug, which is also known as tofacitinib.
CP-690-550 is in Phase 2 clinical development for its investigational indications. It is not approved by the FDA and remains under study. The drug is being evaluated in clinical trials to assess its safety and efficacy for conditions such as rheumatoid arthritis and psoriasis.
CP-690-550 has completed four Phase 1 clinical trials, including NCT01599377, NCT02487433, NCT04111614, and NCT04403776. These trials enrolled healthy volunteers to study bioequivalence, food effects, and pharmacokinetics of different formulations. No active trials are currently listed.
Yes, CP-690-550 is also known as tofacitinib. The drug is referred to by both names in clinical research and development contexts. Pfizer is developing this compound under the name tofacitinib.