Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. FDA label
Also known as Abrocitinib tablet
Abrocitinib · 9 trials · 6 indications
The difference in percentage of responders based on vIGA at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo.
The difference in percentage of responders based on EASI-75 at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo
The number of the treatment emergent adverse events, serious adverse events and adverse events leading to discontinuation among patients with moderate-to-severe disease treated with abrocitinib regardless of discontinuation from study treatment.
The difference in proportion of responders based on EASI-75 at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other situations where medical or scientific judgement should be exercised by investigator. AEs included SAEs and all non-SAEs.
The severity of itch (pruritus) due to atopic dermatitis (AD) was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % 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, with higher scores indicating greater severity of AD.
The incidence of treatment emergent adverse events
The incidence of serious adverse events and adverse events leading to discontinuation
Improvement in the Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) after 6 months of abrocitinib therapy. CSAMI is a validated clinical scoring tool for cutaneous sarcoidosis activity and severity. Scores range from 0 to 165. Higher score is worse.
AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
AUCinfCR was defined as AUCinf corrected for residual concentrations. AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. Two participants in Period 1 and 1 participant in Period 2 had pre-dose caffeine concentrations that were greater than 5% of the corresponding maximum plasma concentration (Cmax). Therefore, AUCinf was corrected for the residual concentrations for these participants.
AUClastCR was defined as AUClast corrected for residual concentrations. AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. Eight participants in Period 2 had pre-dose efavirenz concentrations that were greater than 5% of the corresponding Cmax. Therefore, AUClast was corrected for the residual concentrations for these participants.
Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Maximum observed plasma concentration (Cmax) was measured. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
For the taste assessment in Part B of the study, the data used in the analysis was transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
For the taste assessment in Part B of the study, the data used in the analysis was transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
For the taste assessment in Part B of the study, the data used in the analysis was transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
For the taste assessment in Part B of the study, the data used in the analysis was transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
For the taste assessment in Part B of the study, the data used in the analysis was transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
For the taste assessment in Part B of the study, the data used in the analysis was transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
For the taste assessment in Part B of the study, the data used in the analysis was transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
| Arm | Type | Description |
|---|---|---|
| Abrocitinib | EXPERIMENTAL | Participants will receive liquid oral suspension of Abrocitinib. |
| Matching Placebo | PLACEBO_COMPARATOR | Participants will receive liquid oral suspension of matching placebo. |
| Extension | EXPERIMENTAL | Patients who have completed other abrocitinib studies |
| De novo | EXPERIMENTAL | Patients who have not participated other abrocitinib studies |
| Abrocitinib 100 mg | EXPERIMENTAL | Participants will receive abrocitinib 100 mg by mouth (QD). |
| Abrocitinib 200 mg | EXPERIMENTAL | Participants will receive abrocitinib 200 mg QD. |
| Abrocitinib 200 mg plus placebo injection | EXPERIMENTAL | Abrocitinib 200 mg daily through Week 26, plus placebo injections every other week through Week 24 |
| Dupilumab 300 mg plus placebo tablets | ACTIVE_COMPARATOR | Dupilumab 300 mg every other week (2 injections on Day 1) through Week 24, plus placebo tablets daily through Week 26 |
| Abrocitinib 200 mg daily | EXPERIMENTAL | 6 months of treatment with abrocitinib 200 mg daily |
| Period 1 | OTHER | In Period 1, all the participants will receive single doses of the probe drugs, including caffeine 100 mg, efavirenz 50 mg and omeprazole 10 mg, together on Day 1. |
| Period 2 | OTHER | In Period 2, participants will receive abrocitinib 200 mg once daily (QD) on Day 1-10, single dose of omeprazole on Day 2 and single dose of probe drugs together on Day 8. |
| Part A: Abrocitinib Tablet | EXPERIMENTAL | - |
| Part A: Abrocitinib Suspension F1 | EXPERIMENTAL | - |
| Part A: Abrocitinib Tablet + Famotidine | EXPERIMENTAL | - |
| Part B: Abrocitinib Suspension F1 | EXPERIMENTAL | - |
| Part B: Abrocitinib Suspension F2 | EXPERIMENTAL | - |
| Part B: Abrocitinib Suspension F3 | EXPERIMENTAL | - |
| Part B: Abrocitinib Suspension F4 | EXPERIMENTAL | - |
| Part B: Abrocitinib Suspension F5 | EXPERIMENTAL | - |
| Part B: Abrocitinib Suspension F6 | EXPERIMENTAL | - |
| Part B: Abrocitinib Suspension F1 + Famotidine | EXPERIMENTAL | - |
| Part B: Abrocitinib Suspension F2 + Famotidine | EXPERIMENTAL | - |
| Part B: Abrocitinib Suspension F3 + Famotidine | EXPERIMENTAL | - |
| Part B: Abrocitinib Suspension F4 + Famotidine | EXPERIMENTAL | - |
| Part B: Abrocitinib Suspension F5 + Famotidine | EXPERIMENTAL | - |
| Part B: Abrocitinib Suspension F6 + Famotidine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Abrocitinib | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| Abrocitinib 100 mg | DRUG | Orally administered, abrocitinib 100 mg tablets QD |
| Abrocitinib 200 mg | DRUG | Orally administered, abrocitinib 200 mg tablets QD. |
| Dupilumab 300 mg | COMBINATION_PRODUCT | Dupilumab 300 mg administered as a single subcutaneous injection every other week for 24 weeks (2 injections on day 1). Placebo tablets will be administered daily. |
| Omeprazole | DRUG | single doses of 10 mg |
| Caffeine | DRUG | single dose of 100 mg |
| Efavirenz | DRUG | single doses of 50 mg |
| Abrocitinib tablet | DRUG | Single dose of abrocitinib 200 mg tablet will be administered after an overnight fast of at least 10 hours. |
| Abrocitinib Suspension F1 | DRUG | Single dose of abrocitinib 200 mg oral suspension formulation 1 will be administered after an overnight fast of at least 10 hours. |
| Abrocitinib Suspension F2 | DRUG | Single dose of abrocitinib 200 mg oral suspension formulation 2 will be administered after an overnight fast of at least 10 hours. |
| Abrocitinib Suspension F3 | DRUG | Single dose of abrocitinib 200 mg oral suspension formulation 3 will be administered after an overnight fast of at least 10 hours. |
| Abrocitinib Suspension F4 | DRUG | Single dose of abrocitinib 200 mg oral suspension formulation 4 will be administered after an overnight fast of at least 10 hours. |
| Abrocitinib Suspension F5 | DRUG | Single dose of abrocitinib 200 mg oral suspension formulation 5 will be administered after an overnight fast of at least 10 hours. |
| Abrocitinib Suspension F6 | DRUG | Single dose of abrocitinib 200 mg oral suspension formulation 6 will be administered after an overnight fast of at least 10 hours. |
| Famotidine | DRUG | Single dose of famotidine 40 mg tablet administered 2 hours prior to abrocitinib formulations under fasted conditions. |
Inclusion Criteria: • Children aged 2 to \<6 years at the time of informed consent /assent. Disease Characteristics: * All participants must meet all of the following criteria: * A documented diagnosis of chronic AD for at least 1 year prior to screening and confirmed at screening and baseline vi...
Abrocitinib is being studied for the treatment of atopic dermatitis and eczema, including moderate to severe forms in children and adults. It is also being investigated in sarcoidosis. The drug is an oral small molecule developed by Pfizer and is currently in Phase 3 clinical development for atopic dermatitis.
Abrocitinib targets Janus kinase 1, or JAK1. It is a JAK1 inhibitor, meaning it works by blocking the activity of this enzyme, which plays a role in inflammatory signaling pathways. This mechanism is being explored for inflammatory skin conditions such as atopic dermatitis and eczema.
Abrocitinib is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical trials evaluating abrocitinib in atopic dermatitis, eczema, and sarcoidosis.
Abrocitinib is in Phase 3 clinical development. It has been studied in five trials, with three completed and two currently active. The Phase 3 trials focus on atopic dermatitis and eczema in pediatric patients, while a Phase 2 trial in sarcoidosis has been completed.
Abrocitinib is being evaluated in several clinical trials, including NCT07823595, a Phase 3 study in children aged 2 to less than 6 years with atopic dermatitis; NCT06807281, a long-term Phase 3 study in children aged 2 years and older with moderate to severe eczema; and NCT06807268, a Phase 3 study in children 6 to less than 12 years with moderate-to-severe eczema. A completed Phase 2 trial, NCT05696795, studied JAK inhibition in sarcoidosis.