A Phase 3 interventional study of Abrocitinib 100 mg and Abrocitinib 200 mg in Dermatitis, Atopic, sponsored by Pfizer. Completed at 539 sites in 28 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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Among 20 studies testing abrocitinib in Dermatitis, Atopic — 5 open to participants now, 5 under way, 2 of them phase 3. abrocitinib · Dermatitis, Atopic.
Among the 20 studies testing abrocitinib in Dermatitis, Atopic, this one has the largest enrollment, is one of 5 that started in 2018, is one of 10 in phase 3, and was the 3rd registered.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
Browse Dermatitis, Atopic studies →5 of the 20 studies testing abrocitinib in Dermatitis, Atopic are open now, in 7 countries. Recruiting first, the newest first:
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 12+
Pfizer · Sites in United States, China, Hungary and 4 more countries
Ages 2–11
Pfizer
Ages 2–5
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Ages 18+
University of California, San Francisco · Sites in United States
Ages 18+
By country, each count listing its studies:
abrocitinib: first FDA approval 2022 (CIBINQO), first EMA approval 2021. What it is approved for, and how studies give it, is on its page →
Of the 193 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 94 (49%) stop at 75 or younger; 93 take children under 18; 51 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
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20 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3,166 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Median enrollment 150 across the 20 interventional studies. Of the 15 that completed or were terminated, 11 (73%) have results posted.
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15 of 20 have an industry lead sponsor. The 5 most frequent:
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
58 studies in Dermatitis, Atopic by Pfizer: 11 open now, 13 under way, 4 of them phase 3. Of 43 finished, 34 (79%) have results posted.
Among the 58 studies in Dermatitis, Atopic by Pfizer, this one has the largest enrollment of the 47 interventional ones that give a count, is one of 7 that started in 2018, is one of 17 in phase 3, and was the 14th registered.
Pfizer’s Dermatitis, Atopic studies by the year they started, since 2009.
1 of the studies testing abrocitinib in Dermatitis, Atopic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07848074Fondazione Policlinico Universitario Agostino Gemelli IRCCSAbrocitinib Dose Tapering in Patients With Atopic Dermatitis | 2027-05-01 |
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Among the 20 studies testing abrocitinib in Dermatitis, Atopic, from their registry updates:
Among Pfizer’s 58 in Dermatitis, Atopic:
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B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying parent study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable lengths of study participation. The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country.
The B7451015 study also includes a sub-study evaluating whether abrocitinib has any potential effects on adolescent bone with regard to abnormal bone findings in knee MRI. The sub-study will be conducted in selected countries at selected sites. Eligible subjects are those who were 12 to \<18 years of age at the screening visit of the qualifying parent study and who are currently participating in the main B7451015 study. The sub-study will include serial Magnetic Resonance Imaging (MRI) annually and continue until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued/withdrawn.
Inclusion Criteria:
Female subjects who are of (which includes all female subjects aged 12 years and older, regardless of whether they have experienced menarche) must ot be intending to become pregnant, currently pregnant, or lactating. The following onditions apply:
For Czech Republic only, 5 b. is revised and 5 c. is added to require:
Female subjects of childbearing potential 15 years of age who are at risk of pregnancy must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
c. Female subjects less than 15 years of age must not be sexually active, and abstinence per the below definition should be confirmed prior to enrollment. NOTE: Sexual abstinence, defined as completely and persistently refraining from all heterosexual intercourse (including during the entire period of risk associated with the study treatments) may obviate the need for contraception ONLY if this is the preferred and usual lifestyle of the subject.
6. Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
Achieved status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential. 7. Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
8. Must agree to avoid use of prohibited medications throughout the duration of the study. Exclusion Criteria
There are also additional separate inclusion and exclusion criteria to assess eligibility specifically for the B7451015 MRI sub-study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Abrocitinib 100 mg QD PO
Drug: Abrocitinib 100 mg · Drug: Placebo
Abrocitinib 200 mg QD PO
Drug: Abrocitinib 200 mg · Drug: Abrocitinib 100 mg
In the initial treatment period, Abrocitinib 100 mg, administered as two tablets to be taken orally once daily.
In the initial treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.
For subjects whose dose was changed from 100 mg Abrocitinib to placebo, one tablet will be administered to be taken orally once daily for the remainder of the study.
For subjects whose dose was changed from 200 mg Abrocitinib to 100 mg PF-04965842, one tablet will be administered to be taken orally once daily for the remainder of the study.
In the secondary treatment period, Abrocitinib 100 mg, administered as one tablet to be taken orally once daily.
In the secondary treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.
Treatment emergent adverse events
The incidence of treatment emergent adverse events
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Serious adverse events and adverse events leading to discontinuation
The incidence of serious adverse events and adverse events leading to discontinuation
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change from baseline in clinical laboratory values
Change from baseline in clinical laboratory values
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change from baseline in electrocardiogram (ECG) measurements
Change from baseline in electrocardiogram (ECG) measurements
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change from baseline in vital signs
Change from baseline in vital signs
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Investigator's Global Assessment (IGA)
Response based on the IGA score of clear (0) or almost clear (1) (on a 5 point scale) and a reduction from baseline of \>=2 points at all scheduled time points
Time frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Eczema Area and Severity Index (EASI)
Response based on greater than or equal to 50%, 75% and 90% improvement from baseline in the EASI total score (EASI50, EASI75, and EASI90) at all scheduled time points
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Pruritus Numerical Rating Scale (NRS)
Response based on an improvement greater than or equal to 3 points and greater than or equal to 4 points from baseline in the pruritus NRS at all scheduled time points
Time frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Patient Global Assessment (PtGA)
Change from baseline of PtGA at all scheduled time points
Time frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Body Surface Area (BSA) affected
Change from baseline in the percentage BSA affected at all scheduled time points
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Dermatology Life Quality Index (DLQI) or Children's DLQI (CDLQI)
Change from baseline in DLQI or CDLQI at all scheduled time points
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Patient Oriented Eczema Measure (POEM)
Change from baseline in POEM at all scheduled time points
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Hospital Anxiety and Depression Scale (HADS)
Change from baseline in HADS at all scheduled time points
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96
EuroQol Quality of Life 5 Dimension 5 Level Scale (EQ-5D-5L) or EuroQol Quality of Life 5 Dimension Youth Scale (EQ-5D-Y)
Change from baseline of EQ-5D-5L or EQ-5D-Y at all scheduled time points
Time frame: Baseline, Week 24, Week 48, Week 60, Week 72, Week 92
Steroid-Free Days
Number of steroid-free days will be assessed throughout the duration of the study.
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Serum Hs-CRP Levels
Serum Hs-CRP levels at all scheduled time points
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change in height standard deviation score (SDS)
Change in height standard deviation score (SDS) at all scheduled time points
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Proportion of abnormal findings in knee MRI in adolescent subjects exposed to abrocitinib 100mg and 200mg QD
Proportion of abnormal findings in knee MRI in adolescent subjects exposed to abrocitinib 100mg and 200mg QD
Time frame: Throughout sub-study until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued or withdrawn; an estimated maximum of 4 years
Showing the first 100 of 539 sites across 28 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
Ran from Mar 2018 to primary completion in Dec 2025, 93 months.
Of 149 industry-sponsored phase 3 interventional studies under Dermatitis, Atopic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 28. This study's 93 months is above that.
Counting every sponsor, half of 156 studies reached it within 18 months; a quarter within 13 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Abrocitinib