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Study to Evaluate Safety and Efficacy of Oral MP1032 in Psoriasis Patients

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ClinicalTrials.gov Identifier: NCT02908347
Recruitment Status : Completed
First Posted : September 20, 2016
Last Update Posted : March 21, 2017
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
MetrioPharm AG

Brief Summary:

This Phase IIa study is designed to assess the safety and tolerability of oral MP1032 in patients with moderate to severe psoriasis over a period of 6 weeks. Secondary endpoints to evaluate clinical parameters for psoriasis during the 6 week treatment period and a 4-week follow up will provide an opportunity to perform a first assessment of oral MP1032's clinical efficacy in the treatment of moderate to severe psoriasis.

The study population will consist of 44 enrolled (40 completed) patients with moderate to severe chronic plaque psoriasis. Patients must be able to provide written consent and meet all the inclusion criteria and none of the exclusion criteria.


Condition or disease Intervention/treatment Phase
Psoriasis Plaque Psoriasis Drug: MP1032 Drug: Placebo Phase 2

Detailed Description:

This study is a randomized, double-blind, parallel, placebo-controlled exploratory pilot study to evaluate safety, pharmacokinetics and efficacy of systemic oral (po) administration of 100 mg MP1032 bid in adult patients with moderate to severe chronic plaque psoriasis.

The study design consists of a 28-day screening/run-in period, a 42-day treatment period, 1 day for the End of Treatment visit, and a 28-day follow-up period. Forty-four patients who meet the entry criteria will be randomized on Day 1 in a 1:1 ratio to receive either 100 mg MP1032 or placebo orally twice daily for 42 days. The goal is to have 40 patients (20 in each treatment group) complete the study.

Pharmacokinetic sampling will occur on 3 designated study days. Safety will be monitored from the signing of the informed consent form (ICF) until the last follow-up visit on Day 71.

Efficacy will be assessed on 6 designated study days using the following assessments: PASI, PGA, DLQI, mNAPSI, and EQ-5D 5L (VAS).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized (1:1), Double-blind, Parallel, Placebo-controlled Exploratory Pilot Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Systemic (po) Application of MP1032 in Patients With Moderate to Severe Chronic Plaque Psoriasis
Actual Study Start Date : May 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: MP1032

Test Product:

100 mg MP1032 (= 2 capsules a 50mg) are provided orally twice daily for 42 days

Drug: MP1032
hard gelatine capsules containing 50mg MP1032 as active ingredient

Placebo Comparator: Placebo

Placebo:

2 capsules of Placebo are provided orally twice daily for 42 days

Drug: Placebo
hard gelatine capsules without active ingredient




Primary Outcome Measures :
  1. Safety - Adverse Events (AEs) - Incidence of patients with AEs per Treatment group [ Time Frame: Continuously from the signing of informed consent form (ICF) until the last follow-up visit on Study Day 71 ]

    Incidence of patients with AEs will be determined by treatment group, where applicable.

    Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred, will be determined within each treatment group and system organ class.

    AEs will be collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) will also be handled as AE.


  2. Pharmacokinetics (PK) - Maximum observed concentration (Cmax) [ Time Frame: Study Day 1 ]
    Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose

  3. Pharmacokinetics (PK) - Time corresponding to occurence of Cmax (tmax) [ Time Frame: Study Day 1 ]
    Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose

  4. Pharmacokinetics (PK) - Plasma concentration at 1 timepoint postdose [ Time Frame: Study Days 15, 29 and 43 ]
    Sampling any time postdose (time of the last dose will be recorded)


Secondary Outcome Measures :
  1. Psoriasis Area Severity Index (PASI) [ Time Frame: Enrollment, Study Day 1, 15, 29, 43, 57 and 71 ]

    No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD, median, minimum, maximum) for absolute values and changes from baseline.

    Parameters at Day 29 and End of Treatment (Day 43) will be analyzed using an analysis of covariance (ANCOVA) with baseline data as a covariate and treatment as factor. The difference between placebo and active treatment will be assessed formally using a 2-sided test at the 5% significance level. Estimated means and differences from placebo and 95% confidence intervals will be presented by treatment groups.

    Furthermore response parameters like PASI50 and PASI30 will be displayed in frequency tables and analyzed using chi square and Fisher's exact test at Day 29 and End of Treatment (Day 43).


  2. Physician's Global Assessment (PGA) [ Time Frame: Enrollment, Study Day 1, 15, 29, 43, 57 and 71 ]
    No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD, median, minimum, maximum) for absolute values and changes from baseline.

  3. Dermatology Life Quality Index (DLQI) [ Time Frame: Enrollment, Study Day 1, 15, 29, 43, 57 and 71 ]

    No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD, median, minimum, maximum) for absolute values and changes from baseline.

    Parameters at Day 29 and End of Treatment (Day 43) will be analyzed using an analysis of covariance (ANCOVA) with Baseline data as a covariate and treatment as factor. The difference between placebo and active treatment will be assessed formally using a 2-sided test at the 5% significance level. Estimated means and differences from placebo and 95% confidence intervals will be presented by treatment groups.


  4. EQ-5D 5L visual analogue scale (VAS) [ Time Frame: Enrollment, Study Day 1, 15, 29, 43, 57 and 71 ]
    No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD, median, minimum, maximum) for absolute values and changes from baseline.

  5. Modified Nail Psoriasis Severity Index (mNAPSI) [ Time Frame: Enrollment, Study Day 1, 15, 29, 43, 57 and 71 ]
    No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD, median, minimum, maximum) for absolute values and changes from baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants legally competent to sign and give informed consent.
  2. Adult male and female patients aged 18 to 65 years with chronic plaque psoriasis:

    1. PASI score > 10 at screening and
    2. Disease duration of ≥ 6 months at the initiation of study medication.
  3. Body Mass Index (BMI) between 18.5 and 34.9 kg/m2.
  4. Diagnosis of chronic plaque psoriasis confirmed by a dermatologist/physician.
  5. Women of childbearing potential (WCBP) must have a negative urine pregnancy test at Screening (Visit 1). In addition, sexually active WCBP must agree to use 2 forms of adequate contraception throughout the trial.
  6. Post-menopausal women with spontaneous amenorrhea for at least 12 months and serum levels follicle stimulating hormone (FSH) Levels indicating post-menopausal state as per local laboratory reference ranges. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study. Sterilized women may be included.
  7. Patients must meet the following clinical laboratory criteria:

    1. White blood cell count ≥ 3.5 x 10^9/L
    2. Platelet count ≥ 100 x 10^9/L
    3. Serum creatinine ≤ 1.5 x upper limit of normal (ULN); estimated glomerular filtration rate > 60 mL/min
    4. Total bilirubin ≤ 1.5 x ULN
    5. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 1.5 x ULN
    6. Hemoglobin ≥ lower limit of normal as per local laboratory reference ranges for women and men accordingly
    7. No coagulopathy (International Normalized Ratio [INR] < 1.5).
  8. Patients agree not to increase normal sun exposure during the course of the study.
  9. Patients are able to swallow 2 small capsules during each administration.
  10. Patients are considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator.

Exclusion Criteria:

  1. Patients with non-plaque form of psoriasis (erythrodermic, guttate, pustular or palmo plantar psoriasis; severe form of psoriasis arthritis, inverse form of psoriasis). Mild to moderate cases of psoriasis arthritis are allowed provided there is no impact on study objectives as determined by the Investigator.
  2. Patients with drug-induced psoriasis.
  3. Evidence of skin conditions at the time of screening visit other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
  4. Patients with any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.
  5. Pregnant or lactating females or females planning to become pregnant during the study and/or within 28 days following the last dose of study medication.
  6. Male patients planning a partner pregnancy or sperm donation during the study or within 3 months following the last dose of study medication.
  7. Known allergies to mannitol, macrophage modulators, and gelatin.
  8. Patients with a recent history or current signs or symptoms, as determined by the Investigator, of severe, progressive viral or bacterial infections, of clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic insufficiency disease (excluding psoriasis) requiring systemic treatment or other major diseases, which are not well controlled and may interfere with the conduct of the trial.
  9. Patients with active malignancy or history of malignancy, except for basal cell or squamous cell carcinoma and actinic keratosis. Basal cell carcinoma and small squamous cell carcinoma of the skin which have been excised according to guidelines within the last 5 years or in situ cervical carcinoma that has been fully treated and shows no evidence of recurrence are allowed.
  10. Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening.
  11. Positive human immunodeficiency virus (HIV), hepatitis B or hepatitis C laboratory result.
  12. Previous strong sun exposure (eg, sea holiday) within the 28 days before study medication initiation.
  13. Known photo allergy and/or experienced drug-induced photo toxicity.
  14. Elective (planned) hospitalization or medical intervention preventing patient from following the protocol requirements.
  15. Prior Treatment: Drug class >> Last dose prior to study medication initiation (washout period)

    Topical psoriasis medications (including, but not limited to corticosteroids, calcipotriene, topical vitamin D derivates, retinoids, coal tar) >> 14 days

    Topical immunosuppressive drugs (tacrolimus, pimecrolimus, or anthralin) >> 14 days (Exception: Non-medicated emollients, moisturizers and sunscreens will be allowed), Use of low potency topical steroids for critical areas such as the face, genitalia, and scalp may be allowed until 24 hours prior to randomization.

    Systemic treatment (non-biologic): Systemic immunosuppressant agents (eg: methotrexate, cyclosporine, azathioprine), Systemic fumarate, Systemic corticosteroids >> 28 days

    Phototherapy or photochemotherapy/photosensitizing drugs >> 28 days

    Systemic retinoids >> 12 weeks

    Any investigational drug >> 24 weeks (systemic); 4 weeks (topical)

    Any Anti-TNFs: Infliximab, adalimumab, golimumab, etanercept, etc. >> 12 weeks

    Other Biologics and other systemic therapies: Ustekimumab, alefacept, apremilast, Efalizumab, certolizumab pegol, secukinumab, etc. >> 24 weeks

    Rituximab >> 12 months

  16. Drinking or ingesting grapefruit, pomegranate, grapefruit juice or grapefruit containing products within 14 days of study medication initiation.
  17. Planned use of any ultraviolet (UV) phototherapy or photochemotherapy/photosensitizing drugs during the course of the study and within 28 days following the last dose of the study medication.
  18. Patients with a history of chronic alcohol or drug abuse within 6 months of study medication initiation.
  19. Patients employed by MetrioPharm or a contract research organization (CRO) involved in the clinical study.
  20. Vulnerable patients (eg, patients kept in detention).
  21. Patients who are unable to communicate, read and understand the local language, or who display any other condition, which, in the Investigator's opinion, makes them unsuitable for clinical study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908347


Locations
Germany
Rothaar Studien GmbH
Berlin, Germany, 10783
PAREXEL International GmbH, Klinikum Westend
Berlin, Germany, 14050
Klinische Forschung Dresden GmbH
Dresden, Germany, 01069
Gemeinschaftspraxis Prof. Dr. Vanscheidt und Dr. Ukat
Freiburg, Germany, 79100
Sponsors and Collaborators
MetrioPharm AG
Parexel
Investigators
Principal Investigator: Anke Gauliard, MD Parexel

Responsible Party: MetrioPharm AG
ClinicalTrials.gov Identifier: NCT02908347     History of Changes
Other Study ID Numbers: MP1032-CT02
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MetrioPharm AG:
Plaque psoriasis
chronic
moderate
severe
Plaque

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases