Guselkumab versus Placebo for the Treatment of Psoriatic Arthritis Axial Disease in Bio-naive Participants

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen - Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

6 Aug 2021 → ongoing

Decision date (initial)

2024-05-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-504716-15-00

EudraCT number

2021-000465-32

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Safety, Dose response, Therapy, Pharmacogenomic, Efficacy, Pharmacokinetic, Others

To evaluate the efficacy of guselkumab treatment in participants with
active PsA axial disease by assessing reduction in axial symptoms.

Conditions and MedDRA coding

Psoriatic Arthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1. Be at least 18 years of age
2. 2. Have a diagnosis of PsA for at least 6 months prior to the first administration of study intervention and meet ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria at screening.
3. 3. Have active PsA as defined by: At least 3 swollen joints and at least 3 tender joints at screening and at baseline and C-reactive protein ≥0.3 mg/dL at screening from the central laboratory.
4. 4. Have a BASDAI score of at least 4.
5. 5. Have magnetic resonance imaging-confirmed PsA axial disease
6. 6. Have a spinal pain score of at least 4.
7. 7. Have active plaque psoriasis, with at least one psoriatic plaque of ≥2 cm diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis.
8. 8. Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy.

Exclusion criteria 10

1. 1. Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis, ankylosing spondylitis/non-radiographic-axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease.
2. 2. Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab or other investigative biologic treatment.
3. 3. Has ever received a Janus kinase inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor.
4. 4. Has received any systemic immunosuppressants within 4 weeks of the first administration of study intervention.
5. 5. Has received apremilast within 4 weeks prior to the first administration of study intervention.
6. 6. Has received non-biologic DMARDs other than MTX, SSZ, HCQ, LEF, within 4 weeks before the first administration of study intervention.
7. 7. Currently has a malignancy or has a history of malignancy within 5 years prior to screening
8. 8. Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly.
9. 9. Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection fungal infection, or open, draining, or infected skin wounds or ulcers.
10. 10. Has or has had a serious infection or has been hospitalized or received IV antibiotics for an infection within 2 months prior to screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in BASDAI at Week 24.

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

Sponsor organisation

Janssen - Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Third parties 12

Locations

11 EU/EEA countries · 79 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 201 files

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

Application history

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