JADE clinical trial programme​​​​

Cibinqo has been studied across six Phase III trials as monotherapy or in combination with medicated topical therapies1–7

​​​​​​​

JADE COMPARE1,2
16-week study

Cibinqo in combination with medicated topical therapy in patients aged ≥18 years
• Evaluated skin clearance and itch relief vs placebo at Week 12 (co-primary endpoint) and Week 16
• Dupilumab* as active comparator to evaluate skin clearance and itch relief
• Superiority examined vs dupilumab for itch relief at Week 2
View trial information

JADE MONO-1 and MONO-21,3,4
12-week study

Cibinqo as monotherapy in adults and adolescents ≥12 years

• Evaluated skin clearance and itch relief vs placebo at Week 12

View trial information

JADE REGIMEN1,5
52-week study

Cibinqo treatment durability in adults and adolescents ≥12 years:
• Durability of treatment response
• Risk of flaring following change from Cibinqo 200 mg to either 200 mg, 100 mg or placebo
• Studied across induction, maintenance, dose reduction, withdrawal and rescue therapy strategies
View trial information

JADE TEEN1,6
12-week study

Cibinqo in combination with medicated topical therapy in patients 12–17 years
• Evaluated skin clearance and itch at Week 12
• Evaluated safety in adolescent population
View trial information

JADE EXTEND1,7
Ongoing long-term study

Long-term safety and efficacy of Cibinqo in adults and adolescents aged ≥12 years
• Primary objective is to evaluate the long-term safety of Cibinqo
​​​​​​​• Secondary objective to estimate the long-term efficacy of Cibinqo, including skin clearance and itch relief
View trial information
JADE efficacy endpoints
Efficacy assessments for Cibinqo in the clinical trial programme

Primary and key secondary endpoints

Assessment

Endpoint

Eczema Area and Severity Index (EASI)8

EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation and lichenification (scored separately) for each of four 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.
EASI score:

0 = no symptoms
72 = greatest severity






​​​​​​​

EASI excluded scalp, palms and soles from the assessment/scoring.

Co-primary endpoints

Investigator's Global Assessment (IGA)9

A 5-point scale (0–4) reflecting a global consideration of the erythema, induration and scaling, giving an overall severity of AD.​​​​​​​​​​



​​IGA excluded scalp, palms and soles from the assessment/scoring.

Peak Pruritus Numerical Rating Scale (PP-NRS)10

Patients keep a daily diary of itch severity, recording their worst itching due to AD over the past 24 hours.
0 = no itch

10 = worst possible itch imaginable

Key secondary endpoint

Other secondary endpoints

Assessment

Endpoint

Patient-Oriented Eczema Measure (POEM)2​​​​​​​

POEM is a validated 7-item patient-reported outcome measure used to assess the impact of AD recalled over the past week. It is used to evaluate and measure itch, sleep disturbance, bleeding skin, weeping/oozing skin, cracked skin, flaking skin and dry/rough skin, from the patient’s perspective.
​​​​​​​

​​​​Scores range from 0–28, with higher scores indicating greater severity

Secondary endpoint

SCORing Atopic Dermatitis (SCORAD)2

SCORAD is a validated scoring index for AD, which combines extent (taking into account BSA affected by AD), severity, and subjective symptoms based on itch and sleep loss.
​​​​​​​

​​​​​​​Scores range from 0–103 with higher scores indicating greater severity.

Secondary endpoint

Dermatology Life Quality Index (DLQI)2

DLQI is a validated general dermatology questionnaire that consists of 10 items to assess subject-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).
​​​​​​​

​​​​​​​Scores range from 0–30, with higher scores indicating greater impact on quality of life.

Secondary endpoint

Before/After patient images
Improvement in skin clearance: Patients at Week 12, across skin tones, with or without Rx topicals.
Please note that the following are examples. Patient response to treatment will vary.
Gallery
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 1
GENDER: Male
TRIAL: JADE MONO-2
​​​​​​​DOSAGE: Cibinqo 100 mg
AGE: 24
MEDICATED TOPICALS: No
BASELINE
AT WEEK 12
Patient 2
GENDER: Female
TRIAL: JADE MONO-2
​​​​​​​DOSAGE: Cibinqo 200 mg
AGE: 40
MEDICATED TOPICALS: No
BASELINE
AT WEEK 12
Patient 3
GENDER: Male
TRIAL: JADE MONO-2
​​​​​​​DOSAGE: Cibinqo 200 mg
AGE: 22
MEDICATED TOPICALS: No
BASELINE
AT WEEK 12
Patient 4
GENDER: Male
TRIAL: JADE COMPARE 
DOSAGE: Cibinqo 200 mg
AGE: 21
MEDICATED TOPICALS: Yes
BASELINE
AT WEEK 12
Patient 5
GENDER: Female
TRIAL: JADE MONO-2 
DOSAGE: Cibinqo 100 mg
AGE: 28
MEDICATED TOPICALS: No
BASELINE
AT WEEK 12
Explore more

Safety

3,128 patients were treated with Cibinqo in clinical studies in AD representing 2,089 patient-years of exposure.1

View safety guidance

References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics.

Dosing

Learn more about flexible dosing in patients on Cibinqo.

Discover oral once-daily dosing

** This is an optional area where footnotes can live.

*Dupilumab was an active comparator in JADE COMPARE. Comparisons between the dupilumab group and other trial groups were not multiplicity-controlled, except with respect to itch response at Week 2.

​​​​​​​Images of patients from Cibinqo clinical trials. Not everyone will respond to treatment with Cibinqo. Individual results may vary.

​​​​​​​AD=atopic dermatitis; BSA=body surface area; DLQI=Dermatology Life Quality Index; EASI=Eczema Area and Severity Index; IGA=Investigator's Global Assessment; POEM=Patient-Oriented Eczema Measure; PP-NRS=Peak Pruritus Numerical Rating Scale; SCORAD=SCORing Atopic Dermatitis.
​​​​​​​

Prescribing information:
​​​​​​​
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 200 mg film-coated tablets.
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 100 mg film-coated tablets.
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 50 mg film-coated tablets.


References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics. 2. Bieber T, et al. N Eng J Med 2021;384:1101–1112. 3. Simpson E, et al. Lancet 2020;396:P255–266. 4. Silverberg J, et al. JAMA Dermatol 2021;156(8):863–873. 5. Blauvelt A, et al. JAAD 2021; doi.org/10/1016/j.jaad.2021.05.075. 6. Eichenfield L, et al. JAMA Dermatol 2021; doi: 10.1001/jamadermatol.2021.2830. 7. ClinicalTrials.gov. NCT03422822. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03422822. 8. Hanifin J, et al. Exp Dermatol 2001;10:11–18. 9. Simpson E, et al. J Am Acad Dermatol 2020;83:839–846. 10. Yosipovitch G, et al. Br J Dermatol ​​​​​​​2019;181:761769.
​​​​​​​
PP-CIB-GBR-0061. October 2021
Cibinqo Risk Minimisation Programme (RMP) materials, including a Patient Card and Prescriber Brochure, are available from https://www.medicines.org.uk/emc. Patients treated with Cibinqo should be given the Patient Card.

JADE clinical trial programme

Study overviewJADE Efficacy endpointsBefore/After patient images

© 2021 Pfizer Pte Ltd. All rights reserved.


The information provided in this site is intended only for Health Care Professionals in Singapore. The products discussed herein may have different product labelling in different countries. Pfizer Corporation Singapore Limited is a subsidiary of Pfizer Inc, a pharmaceutical company committed to helping people improve their health by discovering and developing medicines.