Clinical Trials Register

Summary
EudraCT Number:	2020-003977-23
Sponsor's Protocol Code Number:	C3941002
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-11-30
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

2020-003977-23

A.3

Full title of the trial

A PHASE 2A, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07038124 OINTMENT FOR 6 WEEKS IN PARTICIPANTS WITH MILD TO MODERATE ATOPIC DERMATITIS OR PLAQUE PSORIASIS

Randomizowane badanie fazy 2a prowadzone metodą podwójnie ślepej próby, w grupach równoległych, z grupą kontrolną otrzymującą podłoże maści,
oceniające skuteczność, bezpieczeństwo, tolerancję oraz farmakokinetykę maści z PF‐07038124 podawanej przez 6 tygodni pacjentom z atopowym zapaleniem skóry lub łuszczycą plackowatą o nasileniu łagodnym do umiarkowanego

A.3.1

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

A study of the efficacy, safety, tolerability and pharmacokinetics of PF07038124 ointment in participants with eczema or psoriasis

A.4.1

Sponsor's protocol code number

C3941002

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.
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	235 East 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	+18007181021
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.3.2	Product code	PF-07038124
D.3.4	Pharmaceutical form	Ointment
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PF-07038124
D.3.9.2	Current sponsor code	PF-07038124
D.3.9.3	Other descriptive name	PF-07038124
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.1
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	Ointment
D.8.4	Route of administration of the placebo	Topical use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Mild to moderate atopic dermatitis or mild to moderate plaque psoriasis

E.1.1.1

Medical condition in easily understood language

Eczema or psoriasis

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10003639
E.1.2	Term	Atopic dermatitis
E.1.2	System Organ Class	100000004858

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10071117
E.1.2	Term	Plaque psoriasis
E.1.2	System Organ Class	100000004858

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Atopic dermatitis
•To compare the efficacy of PF 07038124 versus vehicle on percent change from baseline in Eczema Area and Severity Index (EASI) in participants with mild or moderate atopic dermatitis (AD).

Plaque psoriasis
•To compare the efficacy of PF 07038124 versus vehicle on change from baseline in Psoriasis Area and Severity Index (PASI) score in participants with mild to moderate plaque psoriasis.

E.2.2

Secondary objectives of the trial

Atopic dermatitis
•To compare the efficacy of PF 07038124 versus vehicle, using Investigator’s Global Assessment (IGA) score assessment as endpoint in participants with mild or moderate AD.
•To compare the efficacy of PF 07038124 versus vehicle, using measures of disease severity and symptoms as endpoints in participants with mild or moderate AD.

For a full list see protocol section 3.

Plaque psoriasis
•To compare the efficacy of PF 07038124 versus vehicle on Physician Global Assessment (PGA) score in participants with mild to moderate plaque psoriasis.
•To compare the efficacy of PF 07038124 versus vehicle on the proportion of participants with mild to moderate plaque psoriasis achieving PASI 75.

For a full list see protocol section 3.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

General Inclusion Criteria Applicable for both AD and psoriasis
1.Male or female participants between the ages of 18 and 70 years, inclusive, at Visit 1 (Screening Visit/time of informed consent).
•Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
2.Body weight ≥50 kg and Body Mass Index (BMI) ≥17.5 kg/m2 up to 40 kg/m2 (inclusive).
3.Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
4.Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. Refer to Section 5.3 for Lifestyle considerations.

AD Specific Inclusion Criteria
1.Have been diagnosed with AD for at least 3 months prior to Day 1; the clinical diagnosis of AD will be confirmed according to the criteria of Hanifin and Rajka7 (Appendix 11).
2.Have an Investigator’s Global Assessment (IGA) score of 2 (mild), or 3 (moderate) at both the Screening and Day 1/Randomization. Note: Refer to Section 8.1.2.2 for the assessment of 5-point IGA.
3.Have AD covering 5% to 20% (inclusive) of BSA (excluding the scalp) at both the Screening and Day 1/Randomization. Note: Refer to Section 8.1.2.3 for detailed methods of calculating treatable BSA.
4.Have an EASI total score of ≥3 to ≤21 at Screening and at Day 1/Randomization. Note: Refer to Section 8.1.2.1 for method of calculating EASI scores.
5.Have a Baseline Peak Pruritis Numerical Rating Scale (PP-NRS) average score of ≥2 assessed at Day 1/Randomization.

Psoriasis Specific Inclusion Criteria
1.Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Day 1.
2.Participants with a Physician Global Assessment (PGA) score of 2 (mild), or 3 (moderate) at Screening and Day 1. Note: Refer to Section 8.1.4.2 for the assessment of 5-point PGA.
3.Having plaque psoriasis covering 5% to 15% (inclusive) of BSA (excluding the scalp) at both the Screening and Day 1/Randomization. Note: Refer to Section 8.1.4.3 for detailed methods of calculating treatable BSA.

E.4

Principal exclusion criteria

The exclusion criteria for AD and psoriasis are the same.
Medical Conditions:
1.Presence of skin comorbidities that would interfere with study assessment or response to treatment.
2.Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria at Screening or Day 1:
a.Suicidal ideation associated with actual intent and/or plan in the past year: “Yes” answers on items 4 “some intent to act without specific plan” or 5 “specific plan and intent” of the Columbia Suicide Severity Rating Scale (C-SSRS);
b.Previous history of suicidal behaviors in the past 5 years: “Yes” answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS;
c.Any lifetime history of serious or recurrent suicidal behavior;
d.The presence of any current major psychiatric disorder that is not explicitly permitted in the inclusion/exclusion criteria;
e.In the opinion of the investigator or Pfizer (or designee) exclusion is required.
3.Current or recent history (within approximately 3 months prior to Day 1) of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
4.A history of systemic (within approximately 3 months prior to Day 1), chronic or acute skin infection (within approximately 2 weeks prior to Day 1) requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator.
5.A known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
6.Undergone significant trauma or major surgery within 1 month prior to screening.
7.Have a history of cancer within 5 years or has undergone treatment for any type of cancer, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ with no evidence of recurrence.
8.Have a history of angioedema or anaphylaxis to topical products or known sensitivity to any of the components of the investigational products.
9.Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.

Prior/Concomitant Therapy:
10.Has received any of the prohibited medications/therapies that may alter the course of the diseases under study without the required minimum washout period or anticipated concomitant use of any of the prohibited medications/therapy (see Appendix 10).

Prior/Concurrent Clinical Study Experience:
11.Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
Note: Any investigational or experimental therapy taken or procedure performed for AD, psoriasis, psoriatic arthritis or rheumatoid arthritis in the previous 1 year should be discussed with the Pfizer Medical Monitor (or designee). Participants cannot participate in studies of other investigational or experimental therapies or procedures at any time during their participation in this study.

Diagnostic Assessments:
12.Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTc interval >450 msec, complete LBBB, signs of an acute or indeterminate-age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant’s eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
13.Participants with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study specific laboratory and confirmed by a single repeat (the last value will be used to determine eligibility), if deemed necessary:
a.Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2;
b.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values ≥2 times the ULN;
c.Total bilirubin ≥1.5 times the ULN; participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is ≤ ULN.

For a full list see protocol section 5.2

E.5 End points

E.5.1

Primary end point(s)

Atopic dermatitis
•Percent change from baseline in EASI total score at Week 6.

Plaque psoriasis
•Change from baseline in PASI score at Week 6.

E.5.1.1

Timepoint(s) of evaluation of this end point

Atopic dermatitis
•Week 6.

Plaque psoriasis
•Week 6.

E.5.2

Secondary end point(s)

Atopic dermatitis
•Proportion of participants achieving IGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 6.
•Proportion of participants achieving EASI 75 (75% improvement from baseline) at study visit time points specified in the SoA.
•Proportion of participants having ≥4 points of reduction in weekly averages of Peak Pruritus Numerical Rating Scale (PP NRS) from baseline at study visit time points specified in the SoA.
•Change from baseline in EASI total score at study visit time points specified in the SoA.
•Proportion of participants achieving IGA score of clear (0) or almost clear (1) at study visit time points specified in the SoA.
•Percent change from baseline in affected Body Surface Area (BSA) at study visit time points specified in the SoA.
•Incidence of treatment emergent adverse events (AEs) and serious adverse events (SAEs), clinically significant changes in vital signs, electrocardiogram (ECG), and laboratory tests.
•Incidence of severity grades in skin tolerability at times indicated in SoA.

Plaque psoriasis
•Proportion of participants with PGA score clear (0) or almost clear (1) (on a 5-point scale) and ≥2 points improvement from baseline at Week 6.
•Proportion of participants achieving PASI 75 (75% or greater improvement from baseline) at study visit time points specified in the SoA.
•Proportion of participants who achieved a Psoriasis Symptoms Inventory (PSI) score of 0 (not at all) or 1 (mild) on every item at study visit time points specified in the SoA.
•Change from baseline in PASI scores at study visit time points specified in the SoA (except Week 6).
•Percent change from baseline in PASI scores at study visit time points specified in the SoA.
•Proportion of participants with PGA score clear (0) or almost clear (1) and ≥2 points improvement from baseline at time points specified in the SoA.
•Percent change from baseline in BSA at study visit time points specified in the SoA
•Incidence of treatment emergent adverse events (AEs) and serious adverse events (SAEs), clinically significant changes in vital signs, electrocardiogram (ECG), and laboratory tests.
•Incidence of severity grades in skin tolerability at times indicated in SoA.

E.5.2.1

Timepoint(s) of evaluation of this end point

Atopic dermatitis
•Week 1 to 6. As per Schedule of Activities - see protocol section 1.3

Plaque psoriasis
•Week 1 to 6. As per Schedule of Activities - see protocol section 1.3

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

Yes

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

Poland

United States

E.8.7

Trial has a data monitoring committee

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)

Yes

F.1.3.1

Number of subjects for this age range:

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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)

No intervention will be provided to study participants at the end of the study.

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

2021-03-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-08-18

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