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Pivotal Trial Results
Post-Hoc Analysis Results
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View EASI-75 data and IGA 0/1 data
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Example
Photos show specific areas of the skin of clinical trial patients diagnosed with moderate-to-severe AD. These may not reflect the full extent or appearance of AD elsewhere on their skin. See clinical trial results throughout. Individual results may vary.
Baseline
Week 2
Week 12
Nonmedicated emollients were allowed.
DOSE: 100 mg
AGE: 45
SEX: Male
TRIAL: MONO-2
IGA AT BASELINE: 4 (Severe)
Clinical trial labels have been blurred in photos.
AD=atopic dermatitis; IGA=Investigator’s Global Assessment.
Nonmedicated emollients were allowed.
DOSE: 100 mg
AGE: 45
SEX: Male
TRIAL: MONO-2
Clinical trial labels have been blurred in photos.
AD=atopic dermatitis.
Nonmedicated emollients were allowed.
DOSE: 100 mg
AGE: 45
SEX: Male
TRIAL: MONO-2
IGA AT BASELINE: 4 (Severe)
IGA AT WEEK 12: 2 (Mild)
The patient did not meet the co-primary endpoint for IGA response as defined in the JADE MONO-2 protocol as an achievement of an IGA score of 0 or 1 with a 2-point improvement from baseline at week 12.
Clinical trial labels have been blurred in photos.
AD=atopic dermatitis; IGA=Investigator’s Global Assessment.
Photos show specific areas of the skin of clinical trial patients diagnosed with moderate-to-severe AD. These may not reflect the full extent or appearance of AD elsewhere on their skin. See clinical trial results throughout. Individual results may vary.
Baseline
Week 2
Week 12
Nonmedicated emollients were allowed.
DOSE: 100 mg
AGE: 28
SEX: Female
TRIAL: MONO-2
IGA AT BASELINE: 3 (Moderate)
AD=atopic dermatitis; IGA=Investigator’s Global Assessment.
Nonmedicated emollients were allowed.
DOSE: 100 mg
AGE: 28
SEX: Female
TRIAL: MONO-2
AD=atopic dermatitis.
Nonmedicated emollients were allowed.
DOSE: 100 mg
AGE: 28
SEX: Female
TRIAL: MONO-2
IGA AT BASELINE: 3 (Moderate)
IGA AT WEEK 12: 1 (Almost clear)
AD=atopic dermatitis; IGA=Investigator’s Global Assessment.
Photos show specific areas of the skin of clinical trial patients diagnosed with moderate-to-severe AD. These may not reflect the full extent or appearance of AD elsewhere on their skin. See clinical trial results throughout. Individual results may vary.
Baseline
Week 2
Week 12
Nonmedicated emollients were allowed.
DOSE: 100 mg
AGE: 24
SEX: Male
TRIAL: MONO-2
IGA AT BASELINE: 3 (Moderate)
AD=atopic dermatitis; IGA=Investigator’s Global Assessment.
Nonmedicated emollients were allowed.
DOSE: 100 mg
AGE: 24
SEX: Male
TRIAL: MONO-2
AD=atopic dermatitis.
Nonmedicated emollients were allowed.
DOSE: 100 mg
AGE: 24
SEX: Male
TRIAL: MONO-2
IGA AT BASELINE: 3 (Moderate)
IGA AT WEEK 12: 2 (Mild)
The patient did not meet the co-primary endpoint for IGA response as defined in the JADE MONO-2 protocol as an achievement of an IGA score of 0 or 1 with a 2-point improvement from baseline at week 12.
AD=atopic dermatitis; IGA=Investigator’s Global Assessment.
Photos show specific areas of the skin of clinical trial patients diagnosed with moderate-to-severe AD. These may not reflect the full extent or appearance of AD elsewhere on their skin. See clinical trial results throughout. Individual results may vary.
Baseline
Week 2
Week 12
Nonmedicated emollients were allowed.
DOSE: 100 mg
AGE: 24
SEX: Male
TRIAL: MONO-2
IGA AT BASELINE: 3 (Moderate)
AD=atopic dermatitis; IGA=Investigator’s Global Assessment.
Nonmedicated emollients were allowed.
DOSE: 100 mg
AGE: 24
SEX: Male
TRIAL: MONO-2
AD=atopic dermatitis.
Nonmedicated emollients were allowed.
DOSE: 100 mg
AGE: 24
SEX: Male
TRIAL: MONO-2
IGA AT BASELINE: 3 (Moderate)
IGA AT WEEK 12: 2 (Mild)
The patient did not meet the co-primary endpoint for IGA response as defined in the JADE MONO-2 protocol as an achievement of an IGA score of 0 or 1 with a 2-point improvement from baseline at week 12.
AD=atopic dermatitis; IGA=Investigator’s Global Assessment.
Photos show specific areas of the skin of clinical trial patients diagnosed with moderate-to-severe AD. These may not reflect the full extent or appearance of AD elsewhere on their skin. See clinical trial results throughout. Individual results may vary.
Baseline
Week 2
Week 12
Nonmedicated emollients were allowed.
DOSE: 100 mg
AGE: 53
SEX: Female
TRIAL: MONO-2
IGA AT BASELINE: 3 (Moderate)
Clinical trial labels have been blurred in photos.
AD=atopic dermatitis; IGA=Investigator’s Global Assessment.
Nonmedicated emollients were allowed.
DOSE: 100 mg
AGE: 53
SEX: Female
TRIAL: MONO-2
Clinical trial labels have been blurred in photos.
AD=atopic dermatitis.
Nonmedicated emollients were allowed.
DOSE: 100 mg
AGE: 53
SEX: Female
TRIAL: MONO-2
IGA AT BASELINE: 3 (Moderate)
IGA AT WEEK 12: 1 (Almost clear)
Clinical trial labels have been blurred in photos.
AD=atopic dermatitis; IGA=Investigator’s Global Assessment.
Photos show specific areas of the skin of clinical trial patients diagnosed with moderate-to-severe AD. These may not reflect the full extent or appearance of AD elsewhere on their skin. See clinical trial results throughout. Individual results may vary.
Baseline
Week 2
Week 12
7-day run-in of nonmedicated emollients was required.
DOSE: 200 mg + TCS
AGE: 21
SEX: Male
TRIAL: COMPARE
IGA AT BASELINE: 4 (Severe)
AD=atopic dermatitis; TCS=topical corticosteroids.
7-day run-in of nonmedicated emollients was required.
DOSE: 200 mg + TCS
AGE: 21
SEX: Male
TRIAL: COMPARE
AD=atopic dermatitis; TCS=topical corticosteroids.
7-day run-in of nonmedicated emollients was required.
DOSE: 200 mg + TCS
AGE: 21
SEX: Male
TRIAL: COMPARE
IGA AT BASELINE: 4 (Severe)
IGA AT WEEK 12: 0 (Clear)
AD=atopic dermatitis; TCS=topical corticosteroids; IGA=Investigator’s Global Assessment.
Photos show specific areas of the skin of clinical trial patients diagnosed with moderate-to-severe AD. These may not reflect the full extent or appearance of AD elsewhere on their skin. See clinical trial results throughout. Individual results may vary.
Baseline
Week 2
Week 12
7-day run-in of nonmedicated emollients was required.
DOSE: 200 mg + TCS
AGE: 21
SEX: Male
TRIAL: COMPARE
IGA AT BASELINE: 4 (Severe)
AD=atopic dermatitis; TCS=topical corticosteroids.
7-day run-in of nonmedicated emollients was required.
DOSE: 200 mg + TCS
AGE: 21
SEX: Male
TRIAL: COMPARE
AD=atopic dermatitis; TCS=topical corticosteroids.
7-day run-in of nonmedicated emollients was required.
DOSE: 200 mg + TCS
AGE: 21
SEX: Male
TRIAL: COMPARE
IGA AT BASELINE: 4 (Severe)
IGA AT WEEK 12: 0 (Clear)
AD=atopic dermatitis; TCS=topical corticosteroids; IGA=Investigator’s Global Assessment.
Photos show specific areas of the skin of clinical trial patients diagnosed with moderate-to-severe AD. These may not reflect the full extent or appearance of AD elsewhere on their skin. See clinical trial results throughout. Individual results may vary.
Baseline
Week 2
Week 12
Nonmedicated emollients were allowed.
DOSE: 200 mg
AGE: 43
SEX: Female
TRIAL: MONO-2
IGA AT BASELINE: 4 (Severe)
Clinical trial labels have been blurred in photos.
AD=atopic dermatitis; IGA=Investigator’s Global Assessment.
Nonmedicated emollients were allowed.
DOSE: 200 mg
AGE: 43
SEX: Female
TRIAL: MONO-2
Clinical trial labels have been blurred in photos.
AD=atopic dermatitis.
Nonmedicated emollients were allowed.
DOSE: 200 mg
AGE: 43
SEX: Female
TRIAL: MONO-2
IGA AT BASELINE: 4 (Severe)
IGA AT WEEK 12: 3 (Moderate)
The patient did not meet the co-primary endpoint for IGA response as defined in the JADE MONO-2 protocol as an achievement of an IGA score of 0 or 1 with a 2-point improvement from baseline at week 12.
Clinical trial labels have been blurred in photos.
AD=atopic dermatitis; IGA=Investigator’s Global Assessment.
Photos show specific areas of the skin of clinical trial patients diagnosed with moderate-to-severe AD. These may not reflect the full extent or appearance of AD elsewhere on their skin. See clinical trial results throughout. Individual results may vary.
Baseline
Week 2
Week 12
Nonmedicated emollients were allowed.
DOSE: 200 mg
AGE: 43
SEX: Female
TRIAL: MONO-2
IGA AT BASELINE: 4 (Severe)
Clinical trial labels have been blurred in photos.
AD=atopic dermatitis; IGA=Investigator’s Global Assessment.
Nonmedicated emollients were allowed.
DOSE: 200 mg
AGE: 43
SEX: Female
TRIAL: MONO-2
Clinical trial labels have been blurred in photos.
AD=atopic dermatitis.
Nonmedicated emollients were allowed.
DOSE: 200 mg
AGE: 43
SEX: Female
TRIAL: MONO-2
IGA AT BASELINE: 4 (Severe)
IGA AT WEEK 12: 3 (Moderate)
The patient did not meet the co-primary endpoint for IGA response as defined in the JADE MONO-2 protocol as an achievement of an IGA score of 0 or 1 with a 2-point improvement from baseline at week 12.
Clinical trial labels have been blurred in photos.
AD=atopic dermatitis; IGA=Investigator’s Global Assessment.
See data showing 4-point improvement in PP-NRS at week 2
Resources such as the discussion guide and patient brochure can help
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