Arthritis interception with Guselkumab in subclinical psoriatic arthritis patients in clinical transition from skin to joint disease: a randomized clinical trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Sanitaria Universitaria Friuli Centrale

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2026-01-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

johnson & johnson

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To determine whether treatment leads to clinical and ultrasonographic
improvement in patients with subclinical PsA by Week 24, defined as the
proportion of subclinical PsA patients who, at Week 24, achieve:
(a) resolution of arthralgia, defined as VAS pain ≤ 1/10 and Tender Joint Count (TJC) ≤ 1/10, and/or
(b) a measurable and significant improvement in synovio-entheseal inflammation, assessed through the UPsA Activity Score compared with baseline.

Secondary objectives 5

1. The change of the synovio-entheseal inflammation score detected by US using the following scoring system (Appendix B)
2. The incidence of progression to PsA (defined as CASPAR criteria fulfillment)
3. The percentage of patients who achieved clinical resolution of arthralgia (defined as VAS pain ≤ 1/10 and TJC ≤ 1/10)
4. The percentage of patients who achieve PASI 100.
5. The change of the Patient Reported Outcomes (e.g. HAQ, BASDAI, DLQI, PsAID).

Conditions and MedDRA coding

PSORIATIC ARTHRITIS PATIENTS IN CLINICAL TRANSITION

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Adult ≥ 18 years of age.
2. Subject must be able to understand and adhere to all protocol requirements and must voluntarily sign and date an informed consent.
3. Subjects are willing and able to comply with procedures required in this protocol.
4. Presence of current from moderate to severe skin psoriasis (PASI≥10) or mild psoriasis (PASI≤10) with the involvement of sensitive area (face, palms, soles, nails, and genital area) diagnosed by a dermatologist with experience in the management of psoriatic disease.
5. Absence of clinical signs of active arthritis, dactylitis, enthesitis and inflammatory back pain at enrolment.
6. Absence of systemic treatment for psoriasis (csDMARDs and/or bDMARDs and/or tsDMARDs treatment) in the last 6 months.
7. The presence of peripheral arthralgia clinically suspected for subclinical PsA (definition in Appendix A)
8. The Presence of at least 2 out of the following 4 sonographic lesions of subclinical inflammation or structural damage suspicious for a psoriatic musculoskeletal inflammation: (i) articular synovitis GS≥ 2 in at least 2 joints; (ii) tenosynovitis GS≥ 1 in at least 2 sites; (iii) active enthesitis in at least one site; (iv) entheseal erosion in at least one site. Ultrasound findings suggestive of subclinical PsA shall be submitted for centralized assessment and independently reviewed by two readers Sonographic Analysis Protocol  The sonographic examination will preferably be performed on the same day as the clinical assessment; however, a delay of up to 72 hours from the clinical evaluation will be tolerated. The ultrasound assessment will be conducted blinded to the clinical examination and focused in a longitudinal and transverse scan of 42 regions encompassing the following: metacarpophalangeal, proximal and distal interphalangeal joints of the hands, wrists, knees, metatarsophalangeal joints, 12 entheses (Achilles, quadriceps, proximal and distal patellar, plantar aponeurosis and common extensor tendon entheses), the 2 retro-calcaneal bursae and 32 tendons (extensor digitorum tendons of the hands, flexor digitorum tendons of the hands and extensor tendon compartments of the wrist). The sites to be scanned and sonographic definitions of the lesions (i.e., synovitis, tenosynovitis, enthesitis, peritenon extensor tendon inflammation and bursitis) and damage lesions (i.e., joint erosions, entheseal erosions, enthesophytes and articular osteoproliferation) will be defined according to the OMERACT and EULAR definitions (Appendix B).

Exclusion criteria 12

1. Contraindication to start a new bDMARD treatment course.
2. Treatment with systemic treatment (csDMARDs or bDMARDs or tsDMARDs) and steroid injection in the 6 months previous enrolment.
3. Has previously received treatment with an IL-23 inhibitor
4. Patients with dementia or an altered mental status, which would preclude the understanding and rendering of informed consent;
5. For women of childbearing potential*: pregnancy status, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3- months after study completion; *A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
6. Known immunodeficiency or patients immunocompromised to an extent that participation in the study would pose and unacceptable risk to the patient;
7. Clinically relevant (chronic or acute) infections, including untreated (latent) tuberculosis, hepatitis B or C or HIV infections;Note: Subjects with a recent acute infection may be enrolled only after full clinical resolution of all signs and symptoms for at least 4 weeks prior to screening.
8. Previous or current diagnosis of PsA.
9. Presence of swollen joints, dactylitis or at clinical examination.
10. Fulfilment of CASPAR criteria for PsA.
11. Subjects with a history of cancer within the past 5 years, as well as those with any current or suspected malignancy at the time of enrollment.
12. Known hypersensitivity or allergy to Guselkumab or to any component of the investigational medicinal product, including excipients.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The percentage of patients with subclinical PsA who achieve resolution of arthralgia (defined as VAS pain ≤ 1/10 and TJC ≤ 1/10) together with the effect of guselkumab on objectively quantified synovio-entheseal inflammation, as co-primary objective endpoint evaluated using the UPsA activity activity Score [Timepoint: Week 24].

Secondary endpoints 6

1. - The change of the synovio-entheseal inflammation score detected by US at w24 and w52
2. - The incidence of progression to PsA (defined as CASPAR criteria fulfilment) at w52
3. - The percentage of patients who achieved clinical resolution of arthralgia (defined as VAS pain ≤ 1/10 and TJC ≤ 1/10) at w52
4. - The percentage of patients who achieve PASI 100 at w24 and w52
5. - The change of the Patient Reported Outcomes (e.g. HAQ, BASDAI, DLQI, PsAID).
6. - Change in total modified Sharp–van der Heijde (mSvH) score from baseline to Week 52, including erosion score and joint space narrowing components.

Investigational products

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

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Sanitaria Universitaria Friuli Centrale

Sponsor organisation

Azienda Sanitaria Universitaria Friuli Centrale

Address

Piazzale Santa Maria Della Misericordia 15

City

Udine

Postcode

33100

Country

Italy

Scientific contact point

Organisation

Azienda Sanitaria Universitaria Friuli Centrale

Contact name

Alen Zabotti

Public contact point

Organisation

Azienda Sanitaria Universitaria Friuli Centrale

Contact name

Alen Zabotti

Locations

1 EU/EEA country · 4 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 12 files

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

Application history

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