Psoriasis vulgaris MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Otetzla®
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Other descriptive name: APREMILAST
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Must be male or female and aged = 18 years at time of consent - Subjects must have diagnosis of moderate to severe Psoriasis vulgaris for at least 6 weeks prior to inclusion and must have active disease of the skin - Indication for systemic treatment of the skin - Patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including fumaric acid, cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). - Biological DMARD (bDMARD) and targeted-synthetic DMARD (tsDMARD) naive - Presence of subclinical inflammation (articular or periarticular: synovialitis, tenosynovitis, osteitis, capsulitis or enthesitis) in Hand MRI and/or bone changes at the MCP joints in HR-pQCT of the dominant hand must be detectable Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Any contraindications for the treatment with apremilast - Previous exposure to apremilast or tsDMARD or bDMARD treatment - Current treatment with tsDMARDs or bDMARDs - Investigational study drug within 4 weeks (or 5 halflives, whichever is longer) prior to randomisation - Any contraindication to perform MRI or failure to perform baseline MRI or HR-pQCT - Patients fulfilling CASPAR criteria for PsA - Anti CCP2 positivity - Evidence of underweight, defined as BMI 11.1 mmol/l rsp. 200 mg/dl, heart insufficiency >= NYHA III, COPD with severity >= GOLD 3, asthma according to GINA classification >= step 3) - Evidence of severe renal dysfunction defined as eGFR < 30 ml/min/1,73 m2 (calculated using the MDRD or CKD-EPI formula) at screening (Visit 1) - Prior history of suicide attempt at any time in the subject's life time prior to screening and baseline, or major psychiatric illness requiring hospitalization within the last 3 years - Pregnant or lactating females - Concomitant medication that can cause psychiatric symptoms (e.g. rifampicine, phenobarbital, carbamazepine, phenytoin, St John's wort)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effects of apremilast treatment on bone changes at the metacarpophalangeal (MCP) joints in Psoriasis patients with bone changes and/or subclinical inflammation.;Secondary Objective: To investigate the effects of apremilast on signs of inflammation in patients with Psoriasis using Hand MRI.;Primary end point(s): Change in osteophyte volume at the metacarpophalangeal head of the second MCP joint measured by HR-pQCT of the dominant hand between baseline and week 24;Timepoint(s) of evaluation of this end point: Baseline and 24 weeks after start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in bone erosion volume at the second and third MCP joint measured by HR-pQCT of the dominant hand between baseline and week 24 - Change in PsAMRIS for the hand (including a composite of inflammatory components) between baseline and week 12 and week 24 - Number of new bone erosions at week 12 and week 24 compared to baseline using Hand MRI - Number of new bone marrow oedema at week 12 and week 24 compared to baseline using Hand MRI - Number of patients with no new bone erosion after 12 and 24 weeks using Hand MRI - Number of patients with no synovitis after 12 and 24 weeks using Hand MRI - Change in tenosynovitis between baseline and week 12 and week 24 using Hand MRI - Number of patients with no tenosynovitis after 12 and 24 weeks using Hand MRI - Number of patients with no new bone erosion after 24 weeks using HR-pQCT of the second and third MCP joint - Number of patients with no new osteophyte after 24 weeks using HR-pQCT of the second and third MCP joint Further Endpoints: - MDA, DAPSA, HAQ-DI, SPARCC, LEI, MASES, PSAID12, PASI, SF-36, PASDAS - optional: retention samples for exploratory biomarker analysis of blood serum, skin biopsies and stool samples ;Timepoint(s) of evaluation of this end point: Baseline, week 12 and week 24 after treatment start | — |
Countries
Germany
Contacts
Public ContactCoordinating Principal Investigator
Universitätsklinikum Erlangen, Medizinische Klinik 3
Outcome results
None listed