Study to Evaluate Efficacy and Safety of MP1032 in Patients With Chronic Plaque Psoriasis

NCT03706209 | Completed Phase 2 Results

• 2 other identifiers: MP1032-CT042017-003484-36
• Study Type: interventional
• Target: 155
• Locations: 2 countries
• Sites: 19

Brief Summary

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.

Conditions

Psoriasis

Keywords

moderate to severe; chronic; plaque psoriasis

Outcome Measures

Primary Outcomes (2)

• PASI 75 - Week 12 (EoT)

  Percentage of patients reaching PASI 75 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at End-of-Treatment (EoT) compared to baseline.

  Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

• PGA Improvement - Week 12 (EoT)

  PGA improvement rate in treatment groups (150 and 300 mg bid) compared to placebo. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at End-of-Treatment (EoT) compared to baseline.

  Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Secondary Outcomes (50)

• PASI 75 VCS - Week 12 (EoT)

  Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

• PGA Improvement VCS - Week 12 (EoT)

  Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

• PASI 50 - Week 12 (EoT)

  Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

• PASI ANCOVA Change From Baseline - Week 12 (EoT)

  Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

• PASI Descriptive Statistics - Week 12 (EoT)

  Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Study Arms (3)

150 mg MP1032 bid

EXPERIMENTAL

3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) are provided twice daily over a period of 12 weeks.

Drug: MP1032; Drug: Placebo

300 mg MP1032 bid

EXPERIMENTAL

6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) are provided twice daily over a period of 12 weeks.

Drug: MP1032

Placebo bid

PLACEBO COMPARATOR

6 × placebo hard gelatin capsules (per dosage) are provided twice daily over a period of 12 weeks.

Drug: Placebo

Interventions

MP1032 DRUG

hard gelatin capsules containing 50mg MP1032 as active ingredient

150 mg MP1032 bid; 300 mg MP1032 bid

Placebo DRUG

hard gelatin capsules containing no active ingredient

150 mg MP1032 bid; Placebo bid

Eligibility Criteria

• Age: 18 Years - 70 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 between 18 years and 70 years with moderate-to-severe chronic plaque psoriasis (diagnosed by Investigator):
• PASI score ≥10 - ≤20 at baseline
• BSA score: \> 10%
• Stable disease duration of ≥ 6 months at the initiation of IMP.
• topical therapy fails to control the disease
• Body Mass Index (BMI) between 18.5 and 34.9 kg/m2.
• 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 method with less than 1% failure rate OR
• Abstinence
• 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)
• In good health as judged by the investigator, based on medical history, physical examination, serum chemistry, hematology and urinalysis
• Patients must meet the following clinical laboratory criteria:
• White blood cell count ≥3.5 × 109/L
• Platelet count ≥100 × 109/L

You may not qualify if:

• Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g. antimalarial drugs, beta-blockers or ACE (angiotensin-converting-enzyme) inhibitors unless on a stable dose for 3 months before IMP intake.
• 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.
• 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.
• Pregnant or lactating women or women planning to become pregnant during the trial and / or within 28 days following the last dose of IMP.
• Male patients planning a partner pregnancy or sperm donation during the trial including follow up period.
• Known allergies to any ingredient of the IMP e.g. mannitol, macrophage modulators, or gelatin.
• 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.
• 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.
• Positive HIV-Antibody, HBs-Antigen or HCV-Antibody-Test at screening.
• Previous strong sun exposure (e.g. sea holiday) within 28 days or UV treatment within 24 weeks before IMP 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 not adhering to defined drug classes and related washout periods (Protocol table 2.)
• 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.
• Patients with a history of chronic alcohol or drug abuse within 6 months of IMP initiation.

Sponsors & Collaborators

• MetrioPharm AG: lead
• Bioskin GmbH: collaborator

Study Sites (19)

Dr. Tsianakas / Dr. Ameluxen

Bad Bentheim, Germany

Location

Rothaar Studien GmbH

Berlin, Germany

Location

Dr. Johannes Niesmann / Dr. Othlinghaus

Bochum, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, Germany

Location

MensingDerma

Hamburg, Germany

Location

MVZ DermaKiel

Kiel, Germany

Location

Hautarztpraxis Dres. med. Scholz, Sebastian, Schilling

Mahlow, Germany

Location

Universitätsmedizin Mainz, Hautklinik und Poliklinik

Mainz, Germany

Location

Klinische Forschung Schwerin (kfsn)

Schwerin, Germany

Location

Centroderm GmbH

Wuppertal, Germany

Location

GynCentrum Sp. Z o.o.

Katowice, Poland

Location

MULTIKLINIKA SALUTE Sp. z o. o.

Katowice, Poland

Location

Provita Sp. z o.o., Centrum Medyczne Angelius Provita

Katowice, Poland

Location

CENTRUM MEDYCZNE PLEJADY Sp. z o. o. spółka komandytowa

Krakow, Poland

Location

Dermoklinika Centrum Medyczne s.c. M.Kierstan, J.Narbutt, A.Lesiak

Lodz, Poland

Location

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, Poland

Location

Kliniczny Szpital Wojewódzki nr 1 im. Fryderyka Chopina w Rzeszowie, Klinika Dermatologii

Rzeszów, Poland

Location

Laser Clinic s.c. Andrzej Królicki, Tomasz Kochanowski

Szczecin, Poland

Location

DermMEDICA Sp. z o.o.

Wroclaw, Poland

Location

MeSH Terms

Conditions

Psoriasis; Bronchiolitis Obliterans Syndrome

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

Results Point of Contact

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

info@metriopharm.com

+49303384395

Publication Agreements

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

Study Design

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

Model Details: Three-arm randomized, double-blind, placebo-controlled, parallel group phase II multi-center trial

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 15, 2018
• Study Start: February 27, 2018
• Primary Completion: June 12, 2019
• Study Completion: June 12, 2019
• Last Updated: November 22, 2024
• Results First Posted: November 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (10); PL (9)