Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-04965842 · 21 trials · 17 indications
The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. 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 AD. Participants who withdrew from the study were counted as non-responder.
IGA assessed severity of atopic dermatitis (AD) on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded scalp, palms and sole.
EASI evaluates severity of participants with AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp.
EASI evaluates severity of participants AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\] on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Percentage of participants with loss of response requiring rescue treatment during double blind period was determined. Loss of response denoted as flare and was define as a loss of at least 50% of EASI total score at Week 12 and with an IGA score of 2 or higher. EASI quantifies severity of participant's atopic dermatitis (AD) based on both severity of lesion clinical signs and % of body surface area (BSA) affected. EASI is a composite scoring by AD clinical evaluator of degree of erythema, induration/papulation, excoriation, and lichenification for each of 4 body regions. EASI total score range from 0.0 to 72.0, with higher scores representing greater severity of AD. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores = more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate and 4 = severe.
Time (in days) to loss of response based on achieving IGA \>=2 was measured from date of first dose of randomized treatment until last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) and based on EASI, loss of at least 50% of EASI response at Week 12 and IGA score of 2 or higher. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores=more severity), reflecting global consideration of erythema, induration and scaling with scores 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. EASI composite score evaluates degree of erythema, induration/papulation, excoriation, and lichenification.
IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Mean fold-changes from baseline at Week 12 in the biomarkers for general inflammation (Matrix Metallopeptidase \[MMP\]12), hyperplasia (Keratin \[KRT\]16), Th2 immune response (C-C motif chemokine ligand \[CCL\]17, CCL18, CCL26), and Th22 immune response (S100 calcium binding protein A \[S100A\]8, S100A9, S100A12), in lesional (LS) and non-lesional (NL) skin tissues, respectively. Expression levels from RT-PCR are normalized to the housekeeping gene RPLP0 by negatively transforming the Ct values to -dCt.
The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
PK parameters derived from plasma PF-04965842 concentration
PK parameters derived from plasma PF-04965842 concentration
PK parameters derived from plasma PF-04965842 concentration
PK parameters derived from plasma PF-04965842 concentration
Area under the curve from time zero to extrapolated infinite time for rosuvastatin
Renal clearance for rosuvastatin
CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).
Area under the curve from time zero to extrapolated infinite time for dabigatran
Maximum observed plasma concentration for dabigatran
Maximum observed plasma PF-04965842 concentration.
Area under the plasma PF-04965842 concentration-time profile from time 0 extrapolated to infinite time.
Maximum observed plasma concentration for active metabolite, PF-06471658 (M1).
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time for active metabolite, PF-06471658 (M1).
Maximum observed plasma concentration for active metabolite, PF-07055087 (M2).
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time for active metabolite, PF-07055087 (M2).
AUCinf is area under the concentration-time curve (AUC) from time 0 (pre-dose) extrapolated to infinite time.
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Maximum observed plasma concentration for PF 04965842
Area under the curve from time zero to extrapolated infinite time tor PF 04965842
To demonstrate the effect of multiple dose PF-04965842 on the pharmacokinetics of a single, oral dose of midazolam in healthy subjects. The lack of an effect of PF-04965842 on midazolam PK will be concluded if the 90% confidence interval for the ratio of adjusted geometric mean for AUCinf falls wholly within (80%, 125%).
Linear mixed effects modeling will be derived from ECGs and PK blood samples at the stated time points with an aim to demonstrate the lack of effect on QTc interval in healthy volunteers, of a supra-therapeutic concentration after administering a dose of 600 mg PF-04965842 compared with placebo.
Total radioactivity in urine and feces based on total administered dose.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Quantitative changes in ECG intervals
Quantitative IgG, IgA, IgM, and IgE levels
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| PF-04965842 100 mg QD | EXPERIMENTAL | active |
| PF-04965842 200 mg QD | EXPERIMENTAL | active |
| PF-04965842 100 mg + Placebo Inj followed by PF-04965842 100mg | EXPERIMENTAL | Once-daily oral PF-04965842 100 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 100 mg from Week 16 to Week 20 |
| PF-04965842 200 mg + Placebo Inj followed by PF-04965842 200mg | EXPERIMENTAL | Once-daily oral PF-04965842 200 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 200 mg from Week 16 to Week 20 |
| Dupilumab Injection + Oral Placebo followed by Oral Placebo | ACTIVE_COMPARATOR | Dupilumab injected subcutaneously once every 2 weeks + once-daily oral Placebo from Day 1 until Week 16 followed by once-daily oral Placebo from Week 16 to Week 20 |
| Oral Placebo + Placebo Inj followed by 100 mg PF-04965842 | PLACEBO_COMPARATOR | Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 100 mg PF-04965842 from Week 16 to Week 20 |
| Oral Placebo + Placebo Inj followed by 200 mg PF-04965842 | PLACEBO_COMPARATOR | Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 200 mg PF-04965842 from Week 16 to Week 20 |
| PF-04965842 100 mg | EXPERIMENTAL | - |
| PF-04965842 200 mg | EXPERIMENTAL | - |
| Placebo QD | PLACEBO_COMPARATOR | Double-blind randomized treatment following open label run-in period. |
| Cohort 1 | EXPERIMENTAL | 10 mg of PF-04965842 QD |
| Cohort 2 | EXPERIMENTAL | 30 mg of PF-04965842 QD |
| Cohort 3 | EXPERIMENTAL | 100 mg of PF-04965842 QD |
| Cohort 4 | EXPERIMENTAL | 200 mg of PF-04965842 QD |
| Cohort 5 | PLACEBO_COMPARATOR | placebo QD |
| PF-04965842 | EXPERIMENTAL | Following an overnight fast for at least 10 hours, participants will receive PF-04965842 oral single dose of 200 mg (2 × 100 mg tablets) on Day 1, at approximately 08:00 am plus or minus 2 hours in the morning. On Days 3 to 8, participants will receive PF-04965842 oral dose of 200 mg (2 × 100 mg tablets) QD in the morning at approximately similar clock hour as on Day 1. On Day 3 and Day 6-8, the dosing of PF-04965842 will be after collection of pre-dose blood samples (under fasted condition for at least 10 hours). On Day 8, the dosing will be under fasted condition at approximately 8:00 am plus or minus 2 hours in the morning. |
| PF-04965842 single dose | OTHER | In Period 1, subjects will be administered a single oral 200 mg dose of PF 04965842 in the morning on Day 1 under fasted conditions. |
| PF-04965842 multiple doses | OTHER | In Period 2, participants will receive oral 200 mg dose of PF-04965842 once daily (QD) in the morning of Day 1 to Day 4 under fasted conditions. |
| Probenecid and PF-04965842 | OTHER | In Period 3, participants will receive probenecid 1000 mg twice daily (BID) in the mornings and evenings of Day 1 to Day 3. On the morning of Period 3 Day 2, after an overnight fast of approximately 8 hours, participants will be administered probenecid 1000 mg. A single 200 mg oral dose of PF 04965842 will be administered approximately 2 hours after the probenecid dose. |
| Arm 1 | EXPERIMENTAL | Single dose of rosuvastatin on Day 1 of Period 1 and Single dose of rosuvastatin on Day 1 + PF-04965842 on Days 1 to 3 of Period 2. |
| Arm 2 | EXPERIMENTAL | Single dose of rosuvastatin on Day 1 + PF-04965842 on Days 1 to 3 of Period 1 and single dose of rosuvastatin on Day 1 of Period 2. |
| Sequence 1 | EXPERIMENTAL | Patients in sequence 1 will received treatment A (metformin) in Period 1 then complete at least 4 days of washout and continue to period 2 where treatment B (PF-04965842 + metformin) will be administered. |
| Sequence 2 | EXPERIMENTAL | Patients in Sequence 2 will start treatment B (PF-04965842 + metformin) then go through a washout period of at least 4 days and continue to Period 2 where treatment A (metformin) will be administered. |
| PF 04965842 | OTHER | In Period 1, subjects will be administered a single oral 200 mg dose of PF 04965842 in the morning on Day 1 under fasted conditions. |
| Rifampin and PF 04965842 | OTHER | In Period 2, subjects will receive rifampin 600 mg QD in the mornings of Day 1 to Day 7, approximately 1 hour before the morning meal. On the morning of Day 8, after an overnight fast of approximately 9 hours, subjects will be administered rifampin 600 mg 1 hour prior to administration of a single 200 mg oral dose of PF 04965842. |
| Sequence 3 | OTHER | Sequential allocation to placebo (oral, single dose), PF-04965842 600 mg (oral, single dose), and moxifloxacin 400 mg (oral, single dose). |
| Sequence 4 | OTHER | Sequential allocation to placebo (oral, single dose), moxifloxacin 400 mg (oral, single dose), and PF-04965842 600 mg (oral, single dose) |
| Sequence 5 | OTHER | Sequential allocation to moxifloxacin 400 mg (oral, single dose), PF-04965842 600 mg (oral, single dose), and placebo (oral, single dose) |
| Sequence 6 | OTHER | Sequential allocation to moxifloxacin 400 mg (oral, single dose), placebo (oral, single dose) and PF-04965842 600 mg (oral, single dose) |
| Mass Balance | EXPERIMENTAL | Cumulative recovery of radioactivity in urine and feces |
| Absolute Bioavailability | EXPERIMENTAL | Oral absolute bioavailability |
| Treatment A | EXPERIMENTAL | - |
| Treatment B | EXPERIMENTAL | - |
| Treatment C | EXPERIMENTAL | - |
| SAD Cohorts 1-8 Experimental Arm | EXPERIMENTAL | - |
| SAD Cohorts 1-8 Placebo Arm | PLACEBO_COMPARATOR | - |
| MAD Cohorts 3 through 5 Experimental Arm | EXPERIMENTAL | - |
| MAD Cohorts 3 through 5 Placebo Arm | PLACEBO_COMPARATOR | - |
| MAD Cohorts 6 and 7 Experimental Arm | EXPERIMENTAL | - |
| MAD Cohorts 6 and 7 Placebo Arm | PLACEBO_COMPARATOR | - |
| MAD Cohort 8 Experimental Arm | EXPERIMENTAL | - |
| MAD Cohort 8 Placebo Arm | PLACEBO_COMPARATOR | - |
| MAD Cohort 9 Experimental Arm | EXPERIMENTAL | - |
| MAD Cohort 9 Placebo Arm | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo |
| PF-04965842 | DRUG | 100 mg QD |
| PF04965842 | DRUG | 200 mg QD |
| PF-04965842 100 mg | DRUG | PF-04965842 100 mg, administered as two tablets to be taken orally once daily as follows: 1. In the arm "PF-04965842 100 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 100 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20; 2. In the arm "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" subjects take PF-04965842 100 mg from Week 16 to Week 20. |
| PF-04965842 200 mg | DRUG | PF-04965842 200 mg, administered as two tablets to be taken orally once daily as follows: 1. In the arm "PF-04965842 200 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 200 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20; 2. In the arm "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842" subjects take PF-04965842 200 mg from Week 16 to Week 20. |
| Dupilumab | DRUG | Two subcutaneous injections of Dupilumab 300 mg as a loading dose administered on Day 1 (for a total of 600 mg) followed by one injection once every two weeks (q2w) until Week 16. |
| Oral Placebo | DRUG | Oral placebo (for PF-04965842) administered as two tablets to be taken orally once daily as follows: 1. In the arm "Dupilumab Injection + Oral Placebo followed by Oral Placebo," the Oral Placebo is taken together with Dupilumab from Day 1 until Week 16, then by itself to Week 20; 2. In the arms "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" and "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842," subjects, take Oral Placebo from Day 1 until Week 16. |
| Injectable Placebo | DRUG | Two subcutaneous injections of Placebo (for Dupilumab) administered as a loading dose on Day 1 followed by one injection every other week (q2w) until Week 16. |
| Probenecid | DRUG | In Period 3, participants will receive probenecid 1000 mg twice daily (BID) in the mornings and evenings of Day 1 to Day 3. On the morning of Period 3 Day 2, after an overnight fast of approximately 8 hours, participants will be administered probenecid 1000 mg. A single 200 mg oral dose of PF 04965842 will be administered approximately 2 hours after the probenecid dose. |
| Rosuvastatin | DRUG | Single 10 mg dose of rosuvastatin |
| Metformin | DRUG | Commercially available metformin (GLUCOPHAGE®) as 500 mg tablets. |
| Dabigatran | DRUG | Single 75 mg dose of dabigatran |
| Ethinyl estradiol (EE) and levonorgestrel (LN) | DRUG | Single dose of Oral tablet containing 30 ug EE and 150 ug of LN |
| rifampin | OTHER | In Period 2, subjects will receive rifampin 600 mg QD in the mornings of Day 1 to Day 7, approximately 1 hour before the morning meal. On the morning of Day 8, after an overnight fast of approximately 9 hours, subjects will be administered rifampin 600 mg 1 hour prior to administration of a single 200 mg oral dose of PF 04965842 |
| Midazolam | DRUG | substrate which undergoes extensive metabolism by CYP3A4 and CYP3A5 and acts as a sensitive probe for evaluating drug interaction with respect to these isoenzymes |
| Moxifloxacin | DRUG | one single dose of 400 mg by mouth |
| Absolute Bioavailability | DRUG | Oral dose of unlabeled PF-04965842 and an IV dose of 14C labeled PF- 04965842 |
| PF- 04965842 | DRUG | Subjects will receive 4 x 100 mg PF 04965842 tablet under fed conditions |
Inclusion Criteria: * Aged between 12 and to 17 with a minimum body weight of 40 kg * Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (\>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4) Exclusion Criteria: * Acute o...
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PF-04965842 is an investigational small molecule being developed by Pfizer for dermatology conditions, including atopic dermatitis. It is also being studied in hepatic impairment and in healthy volunteers for pharmacokinetic assessments. The drug is currently in Phase 3 clinical development for atopic dermatitis.
PF-04965842 is a Janus kinase-1 (JAK1) inhibitor. It works by inhibiting the JAK1 enzyme, which plays a role in inflammatory signaling pathways. This mechanism is being investigated for its potential to treat atopic dermatitis.
PF-04965842 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule in Phase 3 clinical development for atopic dermatitis.
PF-04965842 is in Phase 3 clinical development for atopic dermatitis. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug has completed nine clinical trials, with no active trials currently ongoing.
PF-04965842 has been studied in nine completed clinical trials. These include first-in-human studies (NCT01835197), drug interaction studies (NCT03742336, NCT03937258), and pharmacokinetic studies in Chinese healthy participants (NCT04099563). All trials are completed, with no active trials ongoing.
PF-04965842 is the investigational code name for the drug also known as abrocitinib. It is being developed by Pfizer for atopic dermatitis. The drug is a JAK1 inhibitor currently in Phase 3 clinical development.