CompletedPhase 2

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

Germany46 participantsStarted 2016-05

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

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

Pharmacokinetics (PK) - Plasma Concentrations

Timeframe: Study Days 1, 15, 29 and 43

Pharmacokinetics (PK) - Maximum Observed Concentration (Cmax)

Timeframe: Study Day 1

Pharmacokinetics (PK) - Time

Timeframe: Study Day 1

Trial details

NCT IDNCT02908347

SponsorMetrioPharm AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12

Results submitted2018-08-01

View on ClinicalTrials.gov More Psoriasis trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.