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)

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) - PSARTROS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004798-17-DE

Enrollment

Registered

2015-03-11

Start date

2015-05-26

Completion date

Unknown

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis or prosiatric arthritis MedDRA version: 18.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 18.1 Level: LLT Classification code 10037154 Term: Psoriasis aggravated System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Secukinumab CAS Number: 1229022-83-6 Current Sponsor code: AIN457

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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) Effect of secukinumab on PRO parameters Safety and tolerability of secukinumab 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	—

Measure

Time frame

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) Effect of secukinumab on PRO parameters Safety and tolerability of secukinumab 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

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Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactMedizinische Klinik 3

Universitätsklinikum Erlangen

juergen.rech@uk-erlangen.de004991318543014

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026