Evaluation of inflammatory and structural joint damage in patients with psoriasis and psoriatic arthritis treated with secukinumab: A phase 2, single arm, single centre mode of action study (Psoriasis-Arthritis & Bone Program)

Phase 1

Conditions: Psoriasis or prosiatric arthritis
MedDRA version: 18.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 18.1Level: LLTClassification code 10037154Term: Psoriasis aggravatedSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2014-004798-17-DE

Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Men and women aged 18 years and older
Negative urine pregnancy test in females of child-bearing potential
Adequate wash-out period for subjects previously treated with TNF-alpha inhibitors or ustekinumab
Moderate to severe psoriatric arthritis with symptoms for at least 6 months or moderate to severe psoriasis with inflammatory and/or structural lesions and/or erosions in the MRI/HR-qCT scan
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Radiological evidence of ongoing infectious or malignant process
Intake of high potency opioids
Previous exposure to secukinumab or other biological drugs directly targeting the IL-17 axis
Previous cell-depleting therapies
History of any condition which poses an unacceptable risk for receiving an immunomodulatory therapy
History of alcohol or drug abuse within the last six months before randomization

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Effect of secukinumab on inflammatory and structural signs and symptoms (PsAMRIS score);Secondary Objective: Effect of secukinumab on inflammatory and structural signs and symptoms (other clinical scores and radiological symptoms)<br>Effect of secukinumab on PRO parameters<br>Safety and tolerability of secukinumab<br>Effect of secukinumab on expression of genes of the IL-17 axis;Primary end point(s): Change in PsAMRIS score;Timepoint(s) of evaluation of this end point: 24 weeks after baseline

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in other clinical scores (PASI75, ACR20, DAS28) and imaging signs (erosions, osteo-/enthesiophytes, synovitis)<br>Change in PRO parameters (e.g. HAQ-DI, SF36, PsAQoL1, PSAID, DLQI)<br>Change in vital signs and clinical lab values, occurrence of AEs<br>Change in expression of genes of the IL-17 axis by quantitative real-time PCR<br>Change in cytokine and bone parameters;Timepoint(s) of evaluation of this end point: 24 weeks after baseline