Prospective, multicentre, open-label clinical trial on the effect of GUSelkumab on the resolution of ultrasound-proven ENThEsitis in patients with pSoriatic arthriTis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Erlangen AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

13 Sep 2024 → ongoing

Decision date (initial)

2024-06-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess the effect of Guselkumab on the resolution of clinical and ultrasound-confirmed enthesitis in patients with PsA

Conditions and MedDRA coding

Psoriatic arthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Written informed consent obtained from the subject
2. Adult male or female subject; age ≥ 18 years
3. Diagnosis of PsA according to CASPAR criteria
4. SPARCC Enthesitis ≥ 1 at baseline
5. bDMARD naïve or previous treatment with no more than one TNFi
6. Failure or adverse reaction to at least one csDMARD or indication to start systemic therapy with Guselkumab due to moderate-to-severe plaques psoriasis
7. PD Grade ≥ 2 for at least 1 affected enthesis at baseline or PD Grade ≥ 1 for at least 2 affected entheses at baseline

Exclusion criteria 8

1. Diagnosis of any other rheumatological/ immunological disease such as rheumatoid arthritis, SLE, PSS, MCTD, Behcet syndrome or GPA
2. Concomitant florid active immune mediated disease (e.g. autoimmune hepatitis) that is untreated and/or requires immunosuppressive treatment
3. History of ongoing, chronic or recurrent infectious disease (Infection with HIV, HBV or HCV) or evidence of tuberculosis infection as defined by a positive QuantiFERON Tb-Gold test. If presence of latent tuberculosis is established then treatment according to local country guidelines must have been initiated but patient cannot take part in the study
4. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed), treated or untreated within the past 5 years prior to enrolment
5. History or evidence of ongoing alcohol or drug abuse, within the last six months prior to enrolment
6. Contraindication for Guselkumab treatment according to their SmPCs
7. Use of any inadmissible medication (e.g. drugs under development or bDMARDs approved for PsA other than Guselkumab) List of admitted drugs alongside IMP: • csDMARD - Leflunomide (e.g. Arava), Sulfasalazine (e.g. Azulfidine RA, Pleon RA), Methotrexate (e.g. Lantarel, Metex) and/or • systemic glucocorticoids with a stable dose of ≤ 7,5 mg of prednisolone equivalents within the last 12 weeks of screening
8. Nursing mother or pregnant woman

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Resolution of enthesitis (SPARCC = 0) at week 24

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Erlangen AöR

Sponsor organisation

Universitaetsklinikum Erlangen AöR

Address

Maximiliansplatz 2, Innenstadt Innenstadt

City

Erlangen

Postcode

91054

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Erlangen AöR

Contact name

Prof. Dr. med. Georg Schett

Public contact point

Organisation

Universitaetsklinikum Erlangen AöR

Contact name

Prof. Dr. med. Georg Schett

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 6 files

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

Application history

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