A study that allows patients from previous studies to continue on the medication. The aim of the study is to determine how safe and effective Abrocitinib are when taken as the treatment for moderate to severe atopic dermatitis in patients aged 12 years or older. Patients may also receive topical medications if needed.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

10 Oct 2018 → 23 Dec 2025

Decision date (initial)

2024-05-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Pfizer Inc.

External identifiers

EU CT number

2023-508955-37-00

EudraCT number

2017-004851-22

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To estimate the long-term safety of 100 mg and 200 mg once daily (QD) of abrocitinib with or without topical treatments in adult and adolescent subjects who previously participated in qualifying abrocitinib atopic dermatitis (AD) trials.

Secondary objectives 2

1. To estimate the long-term efficacy of abrocitinib.
2. To evaluate the potential effect of abrocitinib on adolescent growth.

Conditions and MedDRA coding

Moderate to severe atopic dermatitis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

fizer 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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Evidence of a personally signed and dated informed consent document indicating that the subject or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.
2. Male or female subjects of 12 years of age or older, at the time of informed consent meets inclusion criterion for minimum body weight (if applicable) from qualifying Parent study. Adolescent subjects below the age of 18 years old (or country-specific age of majority) will only be enrolled in this study if instructed by the sponsor and approved by the country or regulatory/health authority. If these approvals have not been granted, only subjects aged 18 years (or country-specific age of majority) and older will be enrolled.
3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
4. Must have completed the full treatment period of a qualifying Parent study OR must have completed the full rescue treatment period of a qualifying Parent study (if applicable). OR must have completed the full open-label run-in period in B7451014 and did not meet the protocol-specified response criteria at week 12.
5. Female subjects who are of childbearing potential (which includes all female subjects aged 12 years and older, regardless of whether they have experienced menarche) must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply: a. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to allocation to treatment. b. Female subjects of childbearing potential must agree to use a highly effective method of contraception (as per Section 4.4.1) for the duration of the active treatment period and for at least 28 days after the last dose of investigational product. 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: a. Have undergone a documented hysterectomy and/or bilateral oophorectomy; b. Have medically confirmed ovarian failure; or c. Achieved postmenopausal 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 5

1. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
2. Currently have active forms of other inflammatory skin diseases, ie, not AD or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day -1 that would interfere with evaluation of atopic dermatitis or response to treatment.
3. Discontinued from treatment (or rescue treatment period/open-label run-in period, if applicable) early in a qualifying Parent study OR triggered a discontinuation criterion at any point during the qualifying Parent study OR meets exclusion criteria from qualifying Parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern.
4. Ongoing adverse event in the qualifying Parent study which in the opinion of the investigator, or sponsor, is an ongoing safety concern.
5. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. The incidence of treatment emergent adverse events.
2. The incidence of serious adverse events and adverse events leading to discontinuation.
3. The incidence of clinical abnormalities and change from baseline in clinical laboratory values, electrocardiogram (ECG) measurements, and vital signs.

Secondary endpoints 14

1. Baseline, for efficacy endpoints, is defined as pre-dose Day 1 in the relevant qualifying Parent study: Response based on achieving the Investigator's Global Assessment (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.
2. Response based on achieving ≥ 50%, ≥ 75%, ≥ 90% and 100% improvement from baseline in the Eczema Area and Severity Index (EASI) total score (EASI-50, EASI-75, EASI-90) and EASI-100 at all scheduled time points.
3. Response based on achieving an improvement ≥ 4 points from baseline in the severity of pruritus NRS at all scheduled time points.
4. Change from baseline in the frequency of itching due to Atopic Dermatitis
5. Change from baseline of Patient Global Assessment (PtGA) at all scheduled time points.
6. Change from baseline in the percentage Body Surface Area (BSA) affected at all scheduled time points.
7. Change from baseline in Dermatology Life Quality Index (DLQI) or Children's DLQI (CDLQI) at all scheduled time points.
8. Change from baseline in Patient Oriented Eczema Measure (POEM) at all scheduled time points.
9. Change from baseline in Hospital Anxiety and Depression Scale (HADS) at all scheduled time points.
10. Change from baseline of EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) or EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) at all scheduled time points.
11. Steroid-free days at all scheduled time points.
12. Serum hsCRP levels at all scheduled time points.
13. Change in height standard deviation score.
14. The proportion of abnormal bone findings in knee MRI in adolescent subjects exposed to abrocitinib 100 mg and 200 mg QD

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Locations

3 EU/EEA countries · 32 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications