Clinical and ultrasound assessment of the therapeutic response to ixekizumab in psoriatic arthritis dactlylitis; a multicentre, parallel-groups, randomised controlled trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Ospedaliera Ordine Mauriziano Di Torino

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Decision date (initial)

2025-04-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Eli Lilly Italia · Eli Lilly Italia S.p.A.,

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

The main aims of the present study are:
i. to assess the efficacy of ixekizumab monotherapy versus methotrexate monotherapy in PsA dactylitis;
ii. to evaluate the degree of response by using the DACTOS score

Conditions and MedDRA coding

psoriatic arthritis (PsA)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. - adult age (≥ 18 years); - fulfilment of CASPAR criteria for PsA [2]; - naïve to csDMARDs and/or bDMARDs;; - presence of active dactylitis, diagnosed and evaluated at each centre through physical examination

Exclusion criteria 1

1. -participation in another concurrent clinical intervention study within 30 days of randomization; - planned administration of live vaccines during the study period; - previous treatment with lymphocyte-depleting therapies or alkylating agents; - presence of one or more contraindication reported in datasheets of administered study drugs; - haemoglobin<9.0 g/dL, white-cell count<3.0×109/L, absolute neutrophil count<1.2×109/L, platelet count<100×109/L; - estimated glomerular filtration rate<40 ml/min (method of Cockcroft and Gault); - aspartate aminotransferase and/or alanine aminotransferase >1.5 times the upper normal range; - another autoimmune rheumatic disease except Sjogren’s syndrome; - recent, current, or chronic infection, including hepatitis B or hepatitis C infection or human immunodeficiency virus infection; - evidence of active, latent, or inadequately-treated Mycobacterium Tuberculosis infection; - a history of lymphoproliferative disorder; - major surgery within two weeks before starting study drugs, or having unhealed operation wounds; - history of cancer, except adequately treated, non-metastatic basal-cell or squamous-cell cancer of the skin or cervical carcinoma in situ; - Pregnant or lactating women (women of childbearing potential should have a negative test for HCG); - significant history of alcohol/drug abuse or addiction; - foreseeable inability to cooperate with given instructions and study procedures; - any condition precluding the administration of study drugs in compliance with datasheets indications; - any condition or laboratory parameter precluding the inclusion of the participant according to investigator.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1) To assess the efficacy of ixekizumab monotherapy versus MTX monotherapy in PsA dactylitis 2) To evaluate the degree of response by using the DACTOS score and the change of each sonographic detected elementary lesion of dactylitis in PsA participants

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Ospedaliera Ordine Mauriziano Di Torino

Sponsor organisation

Azienda Ospedaliera Ordine Mauriziano Di Torino

Address

Via Ferdinando Magellano 1

City

Turin

Postcode

10128

Country

Italy

Scientific contact point

Organisation

Azienda Ospedaliera Ordine Mauriziano Di Torino

Contact name

Annamaria Iagnocco

Public contact point

Organisation

Azienda Ospedaliera Ordine Mauriziano Di Torino

Contact name

Annamaria Iagnocco

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications