You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 13, 2024

CLINICAL TRIALS PROFILE FOR ABROCITINIB


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Abrocitinib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03422822 ↗ Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis Enrolling by invitation Pfizer Phase 3 2018-03-08 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 Phase 3 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
NCT03627767 ↗ Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects Completed Pfizer Phase 3 2018-06-11 B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
NCT03915496 ↗ Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis Active, not recruiting Pfizer Phase 2 2020-06-18 B7451037 is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2a study to investigate the mechanism of action of PF-04965842 by correlating efficacy outcomes with changes from baseline in key skin and blood biomarkers in adult participants at least 18 years of age with moderate-to-severe atopic dermatitis. Participants will be screened within 28 days prior to the first dose of study intervention to confirm eligibility. A total of approximately 51 participants will be randomized in a 1:1:1 ratio to receive PF-04965842 200 mg once daily (QD), PF004965842 100 mg QD, or matching placebo QD for 12 weeks. At the end of the 12-week study treatment, qualified participants will have the option to enter the long-term extension study B7451015 (NCT03422822). Participants discontinuing early from this study will undergo a 4-week off-treatment follow-up period.
NCT04345367 ↗ Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy Completed Pfizer Phase 3 2020-06-11 This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will be enrolled from approximately 220 sites globally. Approximately 600 participants will be randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints will be assessed throughout the entire study. Exploratory endpoints related to hand eczema efficacy will be assessed throughout the study.
NCT04903093 ↗ A Study Evaluating Relative Bioavailability of an Oral Suspension of Abrocitinib and Effect of an Acid Reducing Agent on the Bioavailability of Abrocitinib and Assessing the Taste of Abrocitinib Oral Formulations. Completed Pfizer Phase 1 2021-06-04 This study consists of 2 parts: Part A is to estimate the relative bioavailability of a single 200 mg dose of abrocitinib oral suspension (Test formulation) compared to the commercial abrocitinib tablet (200 mg) (Reference formulation). The effect of an acid-reducing agent on the pharmacokinetics of abrocitinib and its metabolites will also be evaluated by administering abrocitinib 200 mg commercial tablet with or without famotidine 40 mg, as an acid-reducing agent. Part B is to assess the taste and palatability of six different abrocitinib oral suspension formulations. Additionally, the safety and tolerability of abrocitinib tablet (in Part A) and abrocitinib oral suspension formulations (in Part B) will be assessed when given with or without famotidine 40 mg once daily.
NCT05038982 ↗ Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin Recruiting Duke University Phase 2 2021-09-09 The primary objective is to assess the efficacy, safety, and tolerability of Abrocitinib for the treatment of Prurigo Nodularis (PN) or Chronic Pruritus of Unknown Origin (CPUO) in patients experiencing moderate to severe pruritus.
NCT05038982 ↗ Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin Recruiting Pfizer Phase 2 2021-09-09 The primary objective is to assess the efficacy, safety, and tolerability of Abrocitinib for the treatment of Prurigo Nodularis (PN) or Chronic Pruritus of Unknown Origin (CPUO) in patients experiencing moderate to severe pruritus.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Abrocitinib

Condition Name

Condition Name for Abrocitinib
Intervention Trials
Atopic Dermatitis 4
Dermatitis, Atopic 2
Skin Diseases 2
Chronic Prurigo 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Abrocitinib
Intervention Trials
Dermatitis 6
Eczema 6
Dermatitis, Atopic 6
Skin Diseases 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Abrocitinib

Trials by Country

Trials by Country for Abrocitinib
Location Trials
United States 88
Canada 26
China 25
Mexico 11
Italy 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Abrocitinib
Location Trials
Florida 6
Texas 4
New York 4
Michigan 4
Massachusetts 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Abrocitinib

Clinical Trial Phase

Clinical Trial Phase for Abrocitinib
Clinical Trial Phase Trials
Phase 4 1
Phase 3 4
Phase 2 5
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Abrocitinib
Clinical Trial Phase Trials
Not yet recruiting 6
Completed 3
Recruiting 2
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Abrocitinib

Sponsor Name

Sponsor Name for Abrocitinib
Sponsor Trials
Pfizer 11
Yale University 2
Duke University 1
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Abrocitinib
Sponsor Trials
Industry 11
Other 7
NIH 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.