Clinical Trials Register

Summary
EudraCT Number:	2017-003484-36
Sponsor's Protocol Code Number:	MP1032-CT04
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-09-27
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

Germany - BfArM

A.2

EudraCT number

2017-003484-36

A.3

Full title of the trial

A Phase II, Multicenter, Double-blind, Placebo-controlled, Efficacy and Safety Study of Two Oral Doses (150 mg bid / 300 mg bid) of MP1032 in Male and Female Patients with Moderate-to-Severe Chronic Plaque Psoriasis

A.3.1

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

A study to evaluate the efficacy of the new drug MP1032 in patients with moderate-to-severe psoriasis

A.4.1

Sponsor's protocol code number

MP1032-CT04

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	MetrioPharm AG
B.1.3.4	Country	Switzerland
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	MetrioPharm AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	MetrioPharm Deutschland GmbH
B.5.2	Functional name of contact point	Info
B.5.3	Address:
B.5.3.1	Street Address	Am Borsigturm 100
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13507
B.5.3.4	Country	Germany
B.5.4	Telephone number	+4930338439502
B.5.5	Fax number	+4960338439599
B.5.6	E-mail	info@metriopharm.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	MP1032 hard gelatin capsules 50 mg
D.3.2	Product code	MP1032
D.3.4	Pharmaceutical form	Capsule, hard
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.3.9.1	CAS number	20666-12-0
D.3.9.2	Current sponsor code	MP1032
D.3.9.3	Other descriptive name	MP1032
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	Capsule, hard
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

chronic Psoriasis Plaque moderate-to-severe

chronische Schuppenflechte mit einer moderaten-bis-schweren Ausprägung

E.1.1.1

Medical condition in easily understood language

chronic Psoriasis Plaque moderate-to-severe

chronische Schuppenflechte mit einer moderaten-bis-schweren Ausprägung

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10050576
E.1.2	Term	Psoriasis vulgaris
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

The primary objective of this trial is to evaluate the clinical efficacy and safety of two oral doses of MP1032 (150 mg bid and 300 mg bid) when taken for 12 weeks by patients with moderate-to-severe chronic plaque psoriasis

E.2.2

Secondary objectives of the trial

- To evaluate the effect of each oral doses of MP1032 (150 mg bid
and 300 mg bid) compared to placebo on the PASI score
- To evaluate the effect of each oral doses of MP1032 (150 mg bid
and 300 mg bid) compared to placebo on the PGA score
- To evaluate the effect of each oral doses of MP1032 (150 mg bid
and 300 mg bid) compared to placebo on the BSA score
- To evaluate systemic exposure of two oral doses of MP1032 (150 mg
bid and 300 mg bid) when taken for 12 weeks by patients with
moderate to severe chronic plaque psoriasis

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Participants legally competent to sign and give informed consent.
2. Adult male and female patients between 18 years and 70 years with moderate-to-severe chronic plaque psoriasis (diagnosed by Investigator):
a) PASI score ≥10 - ≤20 at baseline
b) BSA score: > 10%
c) Stable disease duration of ≥ 6 months at the initiation of IMP.
d) topical therapy fails to control the disease
3. Body Mass Index (BMI) between 18.5 and 34.9 kg/m2.
4. Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening (Visit 1). In addition, sexually active WCBP must agree to use adequate contraception throughout the trial (see Section 3.2 for more details on adequate contraception):
a) A method with less than 1% failure rate OR
b) Abstinence
5. Post-menopausal women with spontaneous amenorrhea for at least 12 months and women on hormonal replacement therapy (HRT). The use of hormonal replacement therapy (HRT) during the trial is permitted, however for these patients an appropriate contraception method according to Inclusion Criterion 4 must be ensured. Sterilized women may be included (see Section 3.2 for more details on sterile definition)
6. Male patients who are sexually active with a female partner and are not surgically sterile (vasectomy performed at least six months prior to treatment) must agree to inform their female sexual partner to use an acceptable form of birth control as described in the informed consent form. For females, an acceptable method (Pearl Index < 1%) would be to use implants, injectable, combined oral contraceptives, some intrauterine devices, or be postmenopausal, be surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy)
7. In good health as judged by the investigator, based on medical history, physical examination, serum chemistry, hematology and urinalysis
8. Patients must meet the following clinical laboratory criteria:
• White blood cell count ≥3.5 × 109/L
• Platelet count ≥100 × 109/L
• Serum creatinine ≤1.5 × upper limit of normal (ULN); estimated glomerular filtration rate >60 mL/min
• Total bilirubin ≤1.5 × ULN
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
• Hemoglobin ≥ lower limit of normal as per central laboratory reference ranges for women and men accordingly
• No coagulopathy (International Normalized Ratio [INR] <1.5)
9. Patients agree to minimize normal sun exposure during the course of the trial
10. Patients are considered reliable and capable of adhering to the protocol (e.g. able to understand the patient information and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator.

E.4

Principal exclusion criteria

1. Patients with non-plaque form of psoriasis (erythrodermic, guttate, pustular form of psoriasis). Associated psoriasis arthritis is allowed provided no other in-/exclusion criteria are influenced, no forbidden concomitant therapy is required for the well-being of the patient and there is no impact on trial objectives as determined by the Investigator.
2. Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g. antimalarial drugs, beta-blockers or ACE inhibitors unless on a stable dose for 3 months before IMP intake.
3. Evidence of skin conditions at the time of Screening Visit other than psoriasis that would interfere with evaluations of the effect of the IMP on psoriasis.
4. Patients with any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the ICF, as assessed by the investigator.
5. Pregnant or lactating women or women planning to become pregnant during the trial and / or within 28 days following the last dose of IMP.
6. Male patients planning a partner pregnancy or sperm donation during the trial including follow up period.
7. Known allergies to any ingredient of the IMP e.g. mannitol, macrophage modulators, or gelatin.
8. History or symptoms of a clinically significant illness in the four weeks before first treatment and during the trial that in the opinion of the investigator may place the patient at risk by trial participation or influence the outcome of the trial. Well controlled diseases such as hypertension, hyperlipidemia, diabetes or hypothyroidism are permitted.
9. Patients with active malignancy or history of malignancy, except for basal cell and actinic keratosis. Basal cell carcinoma of the skin or in situ cervical carcinoma that have been fully treated and show no evidence of recurrence are allowed.
10. Positive HIV-Antibody, HBs-Antigen or HCV-Antibody-Test at screening.
11. Previous strong sun exposure (e.g. sea holiday) within 28 days or UV treatment within 24 weeks before IMP initiation.
12. Known photo allergy and / or experienced drug-induced photo toxicity.
13. Elective (planned) hospitalization or medical intervention preventing patient from following the protocol requirements.
14. Prior treatment not adhering to Table 2.
15. Planned use of any ultraviolet (UV) phototherapy or photochemotherapy / photosensitizing drugs during the course of the trial and within 28 days/24 weeks following the last dose of the IMP.
16. Patients with a history of chronic alcohol or drug abuse within 6 months of IMP initiation.
17. Patients with a blood pressure outside the given range of 160 mm Hg (systolic) and 95 mm Hg (diastolic)
18. Patients who are employed by MetrioPharm, contract research organization (CRO) or clinical site involved in the clinical trial.
19. Vulnerable patients (e.g. patients kept in detention).
20. Patients who are unable to communicate, read or understand the local language, or who display another condition, which, in the Investigator’s opinion, makes them unsuitable for clinical trial participation.
21. Patient is institutionalized because of legal or regulatory order.

E.5 End points

E.5.1

Primary end point(s)

Comparison of each (PASI):
1. Percentage of patients who achieve a 75% improvement (response)
in their PASI score (PASI 75) at Week 12 (Day 84) compared to
baseline treated with 300 mg bid of MP1032 compared to placebo
2. Percentage of patients who achieve a 75% improvement (response)
in their PASI score (PASI 75) at Week 12 (Day 84) compared to
baseline treated with 150 mg bid of MP1032 compared to placebo
And comparison of each (PGA):
3. Improvement (1 or more points on a 7 Point Scale) in PGA at Week
12 (Day 84) compared to baseline treated with 300 mg bid of
MP1032 compared to placebo
4. Improvement (1 or more points on a 7 Point Scale) in PGA Score at
Week 12 (Day 84) compared to baseline treated with 150 mg bid of
MP1032 compared to placebo
5. Adverse events, clinical laboratory, vital signs, PK data, physical
examination

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 84

E.5.2

Secondary end point(s)

• Proportion of patients treated with 300 bid MP1032 compared to
placebo who achieve PASI 50 at Week 12 (d84)
• Proportion of patients treated with 150 bid MP1032 compared to
placebo who achieve PASI 50 at Week 12 (d84)
• PASI score and change to baseline at Week 4 (d28), 8 (d56), 12 (d84)
and week 16 (d112) on the level of individual patients
• Time to achieve PASI 50 and PASI 75
• Mean PASI score and change from Baseline at Week 4 (d28), 8
(d56), and 12 (d84), 16 (d112)
• Mean score and change from Baseline at Week 4 (d28), 8 (d56), and
12 (d84), 16 (d112) in the PGA
• Mean score and change from Baseline at Week 4 (d28), 8 (d56),
and 12 (d84), 16 (d112) in the BSA
• PK data analysis

E.5.2.1

Timepoint(s) of evaluation of this end point

at Week 4 (d28), 8 (d56), and 12 (d84), 16 (d112)

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

Yes

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

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:

140

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

150

F.4.2

For a multinational trial

F.4.2.1

In the EEA

150

F.4.2.2

In the whole clinical trial

150

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 post Trial Treatment planned

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

2017-11-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-01-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-06-12

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