Clinical Trials Register

Summary
EudraCT Number:	2020-001509-21
Sponsor's Protocol Code Number:	B7981037
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-07
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Poland - Office for Medicinal Products

A.2

EudraCT number

2020-001509-21

A.3

Full title of the trial

A PHASE 2a, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY INVESTIGATING THE SAFETY OF RITLECITINIB (PF 06651600) IN ADULT PARTICIPANTS WITH ALOPECIA AREATA

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA

A.4.1

Sponsor's protocol code number

B7981037

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Pfizer Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Pfizer Inc., 66 Hudson Boulevard East, New York, NY 10001
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pfizer Inc.
B.5.2	Functional name of contact point	Clinical Trials.gov Call Centre
B.5.3	Address:
B.5.3.1	Street Address	66 Hudson Boulevard East
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY10001
B.5.3.4	Country	United States
B.5.4	Telephone number	+1 800 7181021
B.5.6	E-mail	ClinicalTrials.gov_Inquiries@pfizer.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Ritlecitinib
D.3.2	Product code	PF-06651600
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ritlecitinib
D.3.9.1	CAS number	Not availabl
D.3.9.2	Current sponsor code	PF-06651600
D.3.9.3	Other descriptive name	Janus Kinase 3 inhibitor
D.3.9.4	EV Substance Code	SUB174316
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Ritlecitinib
D.3.2	Product code	PF-06651600
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ritlecitinib
D.3.9.1	CAS number	Not availabl
D.3.9.2	Current sponsor code	PF-06651600
D.3.9.3	Other descriptive name	Janus Kinase 3 inhibitor
D.3.9.4	EV Substance Code	SUB174316
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Alopecia areata

E.1.1.1

Medical condition in easily understood language

Scalp Hair Loss

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10001761
E.1.2	Term	Alopecia areata
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Primary Safety:
To assess I-V interwave latency on brainstem auditory evoked potentials (BAEPs) in adult participants with alopecia areata (AA) treated with PF-06651600.

E.2.2

Secondary objectives of the trial

Safety:
-To assess I-V interwave latency on BAEPs in adult participants with AA treated with PF-06651600.
-To assess axonal dystrophy in intraepidermal nerve endings over time in adult participants with AA treated with PF 06651600
-To assess intraepidermal nerve fiber density (IENFD) over time in adult participants with AA treated with PF 06651600.
-To assess wave V amplitude on BAEP over time in adult participants with AA treated with PF-06651600.
- To assess presence of wave V on BAEP over time in adult participants with AA treated with PF-06651600.
-To evaluate the safety and tolerability of PF-06651600 in adult participants with AA.
Efficacy:
-To evaluate response to PF-06651600 measured by the Severity of Alopecia Tool (SALT) in adult participants with AA.
-To evaluate the response to PF-06651600 measured by the Patient’s Global Impression of Change (PGI-C) tool in adult participants with AA

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Have a clinical diagnosis of AA and ≥25% scalp hair loss (including AT and AU) due to AA.
2.Have normal hearing and BAEP assessments at screening.
3.Have a normal neurological examination by a neurologist at screening (unilateral carpal tunnel syndrome or median nerve neuropathy permitted).
4.Male or female (not pregnant or breastfeeding) subjects between18 to 50 years.
5.Female (not pregnant or breastfeeding) participants must be either be a WOCBP and using a highly effective contraceptive method or not be of childbearing potential (WOCBP).

E.4

Principal exclusion criteria

1.Other medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior.
2.Any current hearing loss or current disease that can affect hearing.
3.Current or history of clinically significant central or peripheral neurological disease
4.First degree family history of hereditary neuropathy.
5.Any history of peripheral neuropathy (PN), including diabetic PN, chemotherapy-induced PN, drug-induced PN, genetic PN, idiopathic PN, etc.
6.Current or recent history of clinically significant severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine (particularly thyroid disease and parathyroid disease, which can be associated with hair loss), pulmonary, cardiovascular, psychiatric, immunologic (other than AA), rheumatologic, dermatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
7.Any present malignancies or history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
8.History of any lymphoproliferative disorder.
9.History of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
10.History of systemic infection requiring hospitalization, parenteral antimicrobial therapy within 6 months prior to Day 1
11.Known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
12.History of HIV or positive serology for human immunodeficiency virus (HIV) at screening.
13.Considered in imminent need for surgery.
14.Active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1
15.Infection with hepatitis B or hepatitis C viruses.
16.Have evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection.
17.Abnormal findings on the screening chest radiographs (eg, chest x-ray) including, but not limited to, presence of active TB, infection, cardiomyopathy, or malignancy.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in I-V interwave latency on BAEP at a stimulus intensity of 80 decibels (dB) at Month 9.

E.5.1.1

Timepoint(s) of evaluation of this end point

Month 9

E.5.2

Secondary end point(s)

•Change from baseline in I-V interwave latency on BAEP at a stimulus intensity of 80dB at Months 6, 9E, and 15E.
•Change from baseline in axonal dystrophy in skin punch biopsies at Month 9 and Month 15E.
•Change from baseline in IENFD in skin punch biopsies at Month 9 and Month 15E.
•Change from baseline in amplitude of wave V on BAEP at a stimulus intensity of 80dB at Months 6, 9, 9E, and 15E.
•Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB at Months 6, 9, 9E, and 15E.
•Incidence of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and adverse events (AEs) leading to discontinuation;
•Incidence of clinically significant abnormalities in vital signs and ECG;
•Incidence of clinically significant abnormalities in clinical laboratory values.
•Change from baseline in overall and AA SALTa score at Month 9 and other time points collected
•PGI-C score response defined as greatly improved or moderately improved at Month 9 and other time points collected.

E.5.2.1

Timepoint(s) of evaluation of this end point

80dB at Months 6, 9E, and 15E.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Canada

United States

Poland

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

After B7981037 study completion, eligible patients may have the opportunity to receive PF-06651600 in an open-label long term extension study. Beyond that, patients will not have access to PF-06651600 as the efficacy and safety of the investigational product will not be established until marketing approval is granted. After the study ends, patients should be treated by their physicians with appropriate standard of care management and medications when required.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-11-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-12-08

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
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