NCT05250115

A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

Terminated Results posted Last updated 29 September 2025

What this trial tests

trial in Dermatitis, Atopic in 112 participants. Terminated before completion.

Timeline

10 May 2022

Primary endpoint
25 July 2024

25 July 2024

Quick facts

Lead sponsor	Pfizer
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	112
Start date	10 May 2022
Primary completion	25 July 2024
Estimated completion	25 July 2024
Sites	38 locations across Germany

Conditions studied

• Dermatitis, Atopic — all drugs for Dermatitis, Atopic →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Dermatitis, Atopic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) at Month 3 Primary · At Month 3

The IGA is a tool used to assess the severity of AD (excluding scalp, palms and soles) on a 5-point scale that ranges from 0 to 4, where 0 indicates clear (no signs of AD), 1 indicates almost clear (minimal signs of AD), 2 indicates mild AD, 3 indicates moderate AD and 4 indicates severe AD, higher scores indicated greater severity of AD. Percentage of participants with score of "Clear" (score 0) or "Almost Clear" (score 1) according to IGA were reported in this outcome measure.

Group	Value	95% CI
Abrocitinib	35.71

Percentage of Participants With 75% Reduction From Baseline in Eczema Area and Severity Index (EASI) at Month 3 Primary · At Month 3

The EASI assessed both clinical signs of AD as well as extent of disease. For body regions such as "head and neck", "trunk", "upper extremities" and "lower extremities" the extent of eczema was assessed by an area score between 0 (0% of body surface area \[BSA\] affected) and 6 (90 to 100% of BSA affected), respectively. For each area the severity of clinical signs of AD such as "erythema", "edema/papulation", "excoriation" and "lichenification" were scored from 0 to 3, respectively where 0= absent; 1= mild; 2= moderate; 3= severe. The scores for the signs were added for each area and multipli

Group	Value	95% CI
Abrocitinib	47.62

Percentage of Participants Who Achieved IGA Score of Clear (0) or Almost Clear (1) Until End of Study Secondary · From Baseline (Day 1) up to end of study (Month 12)

The IGA is a tool used to assess the severity of AD (excluding scalp, palms and soles) on a 5-point scale that typically ranges from 0 to 4, where 0 indicates clear (no signs of AD), 1 indicates almost clear (minimal signs of AD), 2 indicates mild AD, 3 indicates moderate AD and 4 indicates severe AD, higher scores indicated greater severity of AD. Percentage of participants with score of "Clear" (score 0) or "Almost Clear" (score 1) according to IGA were reported in this outcome measure.

Group	Value	95% CI
Abrocitinib	51.49

Percentage of Participants With 75% Reduction From Baseline in EASI Score Until End of Study Secondary · From Baseline (Day 1) up to end of study (Month 12)

The EASI assessed both clinical signs of AD as well as extent of disease. For body regions such as "head and neck", "trunk", "upper extremities" and "lower extremities" the extent of eczema was assessed by an area score between 0 (0% of BSA affected) and 6 (90 to 100% of BSA affected), respectively. For each area the severity of clinical signs of AD such as "erythema", "edema/papulation", "excoriation" and "lichenification" were scored from 0 to 3, respectively where 0= absent; 1= mild; 2= moderate; 3= severe. The scores for the signs were added for each area and multiplied by the respective a

Group	Value	95% CI
Abrocitinib	63.37

Percentage of Participants With 90% Reduction From Baseline in EASI Score Until End of Study Secondary · From Baseline (Day 1) up to end of study (Month 12)

The EASI assessed both clinical signs of AD as well as extent of disease. For body regions such as "head and neck", "trunk", "upper extremities" and "lower extremities" the extent of eczema was assessed by an area score between 0 (0% of BSA affected) and 6 (90 to 100% of BSA affected), respectively. For each area the severity of clinical signs of AD such as "erythema", "edema/papulation", "excoriation" and "lichenification" were scored from 0 to 3, respectively where 0= absent; 1= mild; 2= moderate; 3= severe. The scores for the signs were added for each area and multiplied by the respective a

Group	Value	95% CI
Abrocitinib	42.57

Percentage of Participants Who Achieved IGA Score of Clear (0) or Almost Clear (1) and a Reduction of >= 2 Points From Baseline Until End of Study Secondary · From Baseline (Day 1) up to end of study (Month 12)

The IGA is a tool used to assess the severity of AD (excluding scalp, palms and soles) on a 5-point scale that typically ranges from 0 to 4, where 0 indicates clear (no signs of AD), 1 indicates almost clear (minimal signs of AD), 2 indicates mild AD, 3 indicates moderate AD and 4 indicates severe AD, higher scores indicated greater severity of AD. Percentage of participants with score of "Clear" (score 0) or "Almost Clear" (score 1) and a reduction of \>=2 points from baseline according to IGA were reported in this outcome measure.

Group	Value	95% CI
Abrocitinib	47.52

Percentage Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12 Secondary · Baseline (Day 1), Months 1, 3, 6, 9 and 12

The IGA is a tool used to assess the severity of AD (excluding scalp, palms and soles) on a 5-point scale that typically ranges from 0 to 4, where 0 indicates clear (no signs of AD), 1 indicates almost clear (minimal signs of AD), 2 indicates mild AD, 3 indicates moderate AD and 4 indicates severe AD, higher scores indicated greater severity of AD.

Month 1

Group	Value	95% CI
Abrocitinib	-38.79	± 33.55

Month 3

Group	Value	95% CI
Abrocitinib	-50.37	± 31.06

Month 6

Group	Value	95% CI
Abrocitinib	-46.05	± 33.15

Month 9

Group	Value	95% CI
Abrocitinib	-41.86	± 32.07

Month 12

Group	Value	95% CI
Abrocitinib	-38.97	± 40.45

Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Months 1, 3, 6, 9 and 12 Secondary · Baseline (Day 1), Months 1, 3, 6, 9 and 12

SCORAD total score was a validated scoring index for AD that assessed severity by combining A: extent, B: severity and C: subjective symptoms. A: a rule of 9 was used to calculate BSA affected by AD as a % of whole-BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. Score for each body region was added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; lichenification; dryness) was assessed as none =0, mild =1, moderate =2, severe =3, severity scores were added to give B (0-18

Month 1

Group	Value	95% CI
Abrocitinib	-48.53	± 28.43

Month 3

Group	Value	95% CI
Abrocitinib	-50.60	± 27.60

Month 6

Group	Value	95% CI
Abrocitinib	-53.41	± 29.64

Month 9

Group	Value	95% CI
Abrocitinib	-43.46	± 31.86

Month 12

Group	Value	95% CI
Abrocitinib	-50.08	± 30.81

Absolute EASI Total Score at Months 1, 3, 6, 9 and 12 Secondary · At Months 1, 3, 6, 9 and 12

The EASI assessed both clinical signs of AD as well as extent of disease. For body regions such as "head and neck", "trunk", "upper extremities" and "lower extremities" the extent of eczema was assessed by an area score between 0 (0% of BSA affected) and 6 (90 to 100% of BSA affected), respectively. For each area the severity of clinical signs of AD such as "erythema", "edema/papulation", "excoriation" and "lichenification" were scored from 0 to 3, respectively where 0= absent; 1= mild; 2= moderate; 3= severe. The scores for the signs were added for each area and multiplied by the respective a

Month 1

Group	Value	95% CI
Abrocitinib	5.09	± 6.57

Month 3

Group	Value	95% CI
Abrocitinib	4.37	± 7.03

Month 6

Group	Value	95% CI
Abrocitinib	3.65	± 4.50

Month 9

Group	Value	95% CI
Abrocitinib	4.70	± 5.47

Month 12

Group	Value	95% CI
Abrocitinib	5.11	± 8.09

Percentage Change From Baseline in EASI Total Score at Months 1, 3, 6, 9 and 12 Secondary · Baseline (Day 1), Months 1, 3, 6, 9 and 12

The EASI assessed both clinical signs of AD as well as extent of disease. For body regions such as "head and neck", "trunk", "upper extremities" and "lower extremities" the extent of eczema was assessed by an area score between 0 (0% of BSA affected) and 6 (90 to 100% of BSA affected), respectively. For each area the severity of clinical signs of AD such as "erythema", "edema/papulation", "excoriation" and "lichenification" were scored from 0 to 3, respectively where 0= absent; 1= mild; 2= moderate; 3= severe. The scores for the signs were added for each area and multiplied by the respective a

Month 1

Group	Value	95% CI
Abrocitinib	-57.00	± 64.37

Month 3

Group	Value	95% CI
Abrocitinib	-70.11	± 31.71

Month 6

Group	Value	95% CI
Abrocitinib	-67.89	± 47.82

Month 9

Group	Value	95% CI
Abrocitinib	-69.16	± 32.03

Month 12

Group	Value	95% CI
Abrocitinib	-71.58	± 35.79

Absolute Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12 Secondary · Baseline (Day 1), Months 1, 3, 6, 9 and 12

The IGA is a tool used to assess the severity of AD (excluding scalp, palms and soles) on a 5-point scale that typically ranges from 0 to 4, where 0 indicates clear (no signs of AD), 1 indicates almost clear (minimal signs of AD), 2 indicates mild AD, 3 indicates moderate AD and 4 indicates severe AD, higher scores indicated greater severity of AD.

Month 1

Group	Value	95% CI
Abrocitinib	-1.31	± 1.16

Month 3

Group	Value	95% CI
Abrocitinib	-1.66	± 1.11

Month 6

Group	Value	95% CI
Abrocitinib	-1.51	± 1.12

Month 9

Group	Value	95% CI
Abrocitinib	-1.39	± 1.06

Month 12

Group	Value	95% CI
Abrocitinib	-1.38	± 1.30

Percentage of Participants Who Achieved at Least 4 Point Improvement on Pruritus Numerical Rating Scale (NRS) From Baseline Until End of Study Secondary · From Baseline (Day 1) up to end of study (Month 12)

The pruritus-NRS comprised of one item and the score ranged from 0 ("no itch") to 10 ("worst imaginable itch"). Higher scores indicated greater severity. Participants were asked to rate the intensity of their average pruritus using this scale. Percentage of participants who achieved at least 4-point improvement on pruritus NRS are reported in this outcome measure.

Group	Value	95% CI
Abrocitinib	42.57

Adverse events — posted to ClinicalTrials.gov

Time frame: From Baseline (Day 1) up to end of study (up to Month 12). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Abrocitinib

Serious: 4/112 (4%)

Deaths: 0/112

Serious adverse events (4 terms)

Reaction	System	Abrocitinib
Eczema herpeticum	Infections and infestations	—
Cutaneous T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Asthma	Respiratory, thoracic and mediastinal disorders	—
Dermatitis atopic	Skin and subcutaneous tissue disorders	—

Other adverse events (5 terms — click to expand)

Reaction	System	Abrocitinib
Nausea	Gastrointestinal disorders	—
Nasopharyngitis	Infections and infestations	—
Hyperlipidaemia	Metabolism and nutrition disorders	—
Acne	Skin and subcutaneous tissue disorders	—
Headache	Nervous system disorders	—

Most-reported serious reactions: Eczema herpeticum, Cutaneous T-cell lymphoma, Asthma, Dermatitis atopic.

Data from ClinicalTrials.gov NCT05250115 adverse events section.

Sponsor's own description

The purpose of this non-interventional observational study is to learn about the safety and effects of the medicinal product (called Abrocitinib) for the potential treatment of moderate to severe atopic dermatitis (AD). AD is a long-lasting disease that causes redness and irritation of the skin. This non-interventional study is seeking participants who is eligible for Abrocitinib treatment according to the summary of product characteristics (SmPC):

* Are aged at least 18 years old
* Have a confirmed diagnosis of AD by a skin doctor
* Decide to start treatment with Abrocitinib as part of routine clinical practice
* Have a personally signed and dated informed consent document. This is used to indicate that the patient has been informed of all pertinent aspects of the study and data privacy aspects

Participants will take the medicinal product as prescribed in the real-world setting. We will examine the experiences of people receiving Abrocitinib. This will help us determine if the medicinal product is effective and safe. Participants will take part in this study for 3 months. During this time, participants will be followed up from the date of their first Abrocitinib prescription for 12 months. During this non-interventional study, some participants may switch to other therapies after their initial Abrocitinib therapy. We will follow these participants further when they switch therapy to monitor their experiences. Participant documentation is expected quarterly as per standard clinical practice.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and Safety of JAK1 Inhibitor Abrocitinib in Atopic Dermatitis.
   Iznardo H, Roé E, Serra-Baldrich E, Puig L. · · 2023 · cited 22× · PMID 36839707 · DOI 10.3390/pharmaceutics15020385
2. Novel Janus Kinase Inhibitors in the Treatment of Dermatologic Conditions.
   Ryguła I, Pikiewicz W, Kaminiów K. · · 2023 · cited 6× · PMID 38138551 · DOI 10.3390/molecules28248064