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

NCT02908347 | Completed Phase 2 Results

• 1 other identifier: MP1032-CT02
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

Brief Summary

This Phase IIa study is designed to assess the safety, tolerability and pharmacokinetics 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.

Conditions

Psoriasis; Plaque Psoriasis

Keywords

Plaque psoriasis; chronic; moderate; severe; Plaque

Outcome Measures

Primary Outcomes (9)

• Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs

  Number of TEAEs (Treatment Emergent Adverse Events) occured was determined by treatment group. 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 throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are 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) were also handled as AE.

  Continuously from Treatment Start until the last follow-up visit on Study Day 71

• Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC

  Number of related TEAEs (Treatment Emergent Adverse Events) occured by SOC (System Organ class) was determined by treatment group. 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 throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are 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) were also handled as AE.

  Continuously from Treatment Start until the last follow-up visit on Study Day 71

• Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs

  Number of patients with TEAEs (Treatment Emergent Adverse Events) was determined by treatment group. 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 throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are 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) were also handled as AE.

  Continuously from Treatment Start until the last follow-up visit on Study Day 71

• Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC

  Number of patients with related TEAEs (Treatment Emergent Adverse Events) occured by SOC (System Organ class) was determined by treatment group. 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 throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are 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) were also handled as AE.

  Continuously from Treatment Start until the last follow-up visit on Study Day 71

• Pharmacokinetics (PK) - Plasma Concentrations

  Study Day 1 - sampling 15 minutes, 30 minutes, 1 hour and 2 hours postdose Study Days 15, 29 and 43 - only one sample was taken any time postdose (time of the last dose was recorded). No statistical Evaluation has been performed.

  Study Days 1, 15, 29 and 43

• Pharmacokinetics (PK) - Maximum Observed Concentration (Cmax)

  Maximum observed plasma concentration (Cmax)as observed on Day 1 with sampling times of 15 minutes, 30 minutes, 1 hour, and 2 hours postdose

  Study Day 1

• Pharmacokinetics (PK) - Time

  Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose t max = Time corresponding to occurence of Cmax t last = Time of last quantifiable concentration

  Study Day 1

• Pharmacokinetics (PK) - Area Under the Curve (AUC)

  AUC (lin-log) - Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose AUC 2h = area under the plasma concentration-time curve from time zero to 2 hours AUC t = area under the plasma concentration-time curve from time zero to the last quantifiable concentration.

  Study Day 1

• Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups

  AUC (lin-log) - Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose AUC 2h = area under the plasma concentration-time curve from time zero to 2 hours AUC t = area under the plasma concentration-time curve from time zero to the last quantifiable concentration.

  Study Day 1

Secondary Outcomes (10)

• Psoriasis Area Severity Index (PASI) - Observed PASI Values

  Study Day 1, 43, 57 and 71

• Psoriasis Area Severity Index (PASI) - Change From Baseline

  Study Day 1 and 43

• Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUC2h

  Study Day 1, 29 and 43

• Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUCt

  Study Day 1, 29 and 43

• Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Number of Patients

  Study Day 1, 29 and 43

Study Arms (2)

MP1032

EXPERIMENTAL

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

Drug: MP1032

Placebo

EXPERIMENTAL

Placebo to MP1032: 2 capsules of Placebo are provided orally twice daily for 42 days

Drug: Placebo

Interventions

MP1032 DRUG

hard gelatine capsules containing 50 mg MP1032 as active ingredient

MP1032

Placebo DRUG

hard gelatine capsules without active ingredient

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants legally competent to sign and give informed consent.
• Adult male and female patients aged 18 to 65 years with chronic plaque psoriasis:
• PASI score \> 10 at screening and
• Disease duration of ≥ 6 months at the initiation of study medication.
• Body Mass Index (BMI) between 18.5 and 34.9 kg/m2.
• Diagnosis of chronic plaque psoriasis confirmed by a dermatologist/physician.
• 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.
• 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.
• Patients must meet the following clinical laboratory criteria:
• White blood cell count ≥ 3.5 x 10\^9/L
• Platelet count ≥ 100 x 10\^9/L
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN); estimated glomerular filtration rate \> 60 mL/min
• Total bilirubin ≤ 1.5 x ULN
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 1.5 x ULN
• Hemoglobin ≥ lower limit of normal as per local laboratory reference ranges for women and men accordingly

You may not qualify if:

• 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.
• Patients with drug-induced psoriasis.
• 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.
• Patients with any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.
• 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.
• Male patients planning a partner pregnancy or sperm donation during the study or within 3 months following the last dose of study medication.
• Known allergies to mannitol, macrophage modulators, and gelatin.
• 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.
• 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.
• Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening.
• Positive human immunodeficiency virus (HIV), hepatitis B or hepatitis C laboratory result.
• Previous strong sun exposure (eg, sea holiday) within the 28 days before study medication initiation.
• Known photo allergy and/or experienced drug-induced photo toxicity.
• Elective (planned) hospitalization or medical intervention preventing patient from following the protocol requirements.
• Prior Treatment: Drug class \>\> Last dose prior to study medication initiation (washout period)

Sponsors & Collaborators

• MetrioPharm AG: lead
• Parexel: collaborator

Study Sites (4)

Rothaar Studien GmbH

Berlin, 10783, Germany

Location

PAREXEL International GmbH, Klinikum Westend

Berlin, 14050, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 01069, Germany

Location

Gemeinschaftspraxis Prof. Dr. Vanscheidt und Dr. Ukat

Freiburg im Breisgau, 79100, Germany

Location

MeSH Terms

Conditions

Psoriasis; Bronchiolitis Obliterans Syndrome; Lymphoma, Follicular; Plaque, Amyloid

Interventions

sodium luminolate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Disclosure Officer
• Organization: MetrioPharm Deutschland GmbH

info@metriopharm.com

+49303384395

Study Officials

• Anke Gauliard, MD

  Parexel

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: September 20, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)