A Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Psoriatic Arthritis, Spondyloarthritis, Axial

In brief

A Randomized, Placebo-controlled, Multicenter, Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients with Active Psoriatic Arthritis (UP-SPOUT)

Key facts

Study ID

NCT06454188

Run by

CARE ARTHRITIS LTD.

People needed

100

Starts

2024-12-03

Expected to finish

2028-10-01

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject ≥18 of age at the screening visit.
• Subject must be able to understand and willing to adhere to all protocol requirements and voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
• Diagnosis of PsA by their treating rheumatologist.
• Classification of PsA according to the CASPAR criteria19: Inflammatory articular disease (joint, spine, or entheseal) AND at least 3 points of the following categories:
• a) Evidence of psoriasis: (Score for one of the following) i) Current psoriasis - 2 points (Psoriatic skin or scalp disease present today as judged by a dermatologist or rheumatologist) ii) Personal history of psoriasis - 1 point (A history of psoriasis that may be obtained from the subject, family physician, dermatologist, rheumatologist, or other qualified health care provider) iii) Family history of psoriasis - 1 point (A history of psoriasis in a first- or second-degree relative according to subject report) b) Psoriatic nail dystrophy - 1 point i) Typical psoriatic nail dystrophy, including onycholysis, pitting, and hyperkeratosis, observed on current physical examination c) A negative test for rheumatoid factor - 1 point i) By any method except latex, but preferably by enzyme-linked immunosorbent assay (ELISA) or nephelometry, according to the local laboratory reference range d) Dactylitis: (Score for 1 of the following) i) Current dactylitis - 1 point (Swelling of an entire digit) ii) History of dactylitis - 1 point (A history of dactylitis recorded by a rheumatologist) e) Radiologic evidence of juxta-articular new bone formation - 1 point i) Ill-defined ossification near joint margins (but excluding osteophyte formation) on plain radiographs of the hand or foot.
• Evidence of axial involvement (e.g., active inflammation, structural changes) that has been demonstrated by previous imaging techniques (e.g., radiography, MRI, CT), is considered indicative of axial disease by central reader assessment (2 readers and adjudicator).
• Screening/baseline MRI demonstrates definite active inflammation on MRI of SIJ and/or spine (ASAS definition of positive MRI and ≥4 SIJ quadrants with BME and/or ≥4 vertebral units with BME (in the absence of degenerative disc disease at those discovertebral units with BME)) as determined by central readers.
• Presence of chronic back pain in the 3 months prior to screening.
• Active disease as defined by a BASDAI value of ≥4 and TBP score of ≥4 (on a 0-10 NRS scale) at screening and baseline.
• History of an inadequate response to at least two different NSAIDs over a period of 4 weeks in total at the maximum recommended or tolerated doses, or intolerance/contraindication (e.g., allergic reaction, gastrointestinal symptoms or signs, severe arterial hypertension, etc.) for NSAIDs.
• For all females of child-bearing potential: must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at Baseline prior to the first dose of study drug (local practices may require serum pregnancy testing at Baseline). Subjects with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥3 days later to document continued lack of a positive result (unless prohibited by local requirements).
• Female subjects of childbearing potential must practice at least 1 protocol-specified method of birth control that is effective from Study Day 1 through at least 30 days after the last dose of study drug (local practices may require 2 methods of birth control). Female subjects of non-childbearing potential do not need to use birth control.
• Females must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug. Females must commit to one of the following methods of highly effective birth control:
• Combined (estrogen- and progestogen-containing) hormonal birth control (oral, intravaginal, transdermal, injectable) associated with inhibition of ovulation initiated at least 30 days prior to study baseline.
• Progestogen-only hormonal birth control (oral, injectable, implantable) associated with inhibition of ovulation initiated at least 30 days prior to study baseline.
• Bilateral tubal occlusion/ligation (can be via hysteroscopy, provided a hysterosalpingogram confirms success of the procedure) (For Japan: only bilateral tubal ligation).
• Intrauterine device (IUD).
• Intrauterine hormone-releasing system (IUS).
• Vasectomized sexual partner (the partner has received medical confirmation of the surgical success of the vasectomy and is the sole sexual partner of the trial subject).
• Practice true abstinence (unless not acceptable per local practices), defined as: refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable).
• If required per local practices, females of childbearing potential must commit to using 2 methods of contraception (either 2 highly effective methods or 1 highly effective method combined with 1 effective method). Effective methods of birth control are the following:
• Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, initiated at least 30 days prior to baseline.
• Male or female condom with or without spermicide.
• Cap, diaphragm, or sponge with spermicide.
• A combination of male condom with a cap, diaphragm, or sponge with spermicide (double barrier method).

You may not qualify if…

• Active infection(s) requiring treatment with parenteral anti-infectives within 30 days, or oral anti-infectives within 14 days prior to the baseline Visit; Chronic recurring infection and/or active viral infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study.
• Confirmed COVID-19: the baseline visit must be at least 14 days from onset of signs/symptoms or positive SARS-CoV-2 test; symptomatic subjects must have recovered, defined as resolution of fever without use of antipyretics and improvement in symptoms;
• Suspected COVID-19: subjects with signs/symptoms suggestive of COVID-19, known exposure, or high-risk behavior should undergo molecular (e.g., PCR) testing to rule out SARS-CoV-2 infection or must be asymptomatic for 14 days from a potential exposure;
• History of recurrent (more than one episode) herpes zoster or disseminated/multi-dermatomal (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
• Primary or secondary immunodeficiency.
• Current clinical signs and symptoms suggestive for tuberculosis.
• Tuberculosis Interferon Gamma Release Assay (IGRA) serum test and abnormal chest x-ray (positive x-ray) suggestive of past or present tuberculosis (both at screening, may be accepted if performed within 180 days prior to screening). If the IGRA test is indeterminate the test should be repeated. If it remains indeterminate the patient should be considered positive. Patients with a positive Tuberculosis IGRA serum test but negative chest x-ray and without clinical symptoms suggestive for tuberculosis may participate in the study after initiation of standard prophylactic anti-tuberculous treatment according to the current local treatment guidelines. At least 2 weeks prophylactic treatment is considered necessary prior to study participation. Patients should not take rifampin concurrently with Upadacitinib.
• Chronic infection with hepatitis B virus. At screening HBsAg and anti-HBc will be tested. Patients who are HBsAg positive will be excluded. In case of HBsAg negativity, but anti-HBc positivity, participation in the study is possible if HBV-DNA testing is negative and liver function tests are normal.
• Chronic infection with hepatitis C (HCV) (HCV ribonucleic acid (RNA) detectable in any subject with anti-HCV antibody (HCV Ab), or Human Immunodeficiency Virus (HIV) infection confirmed by positive anti-HIV antibody test.
• Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 4 weeks following the last dose of study drug.
• Subjects with chronic inflammatory articular disease (other than PsO or PsA or SpA), or systemic autoimmune diseases, e.g., systemic lupus erythematosus, Sjögren´s syndrome, RA, unequivocal chronic fatigue syndrome, or unequivocal fibromyalgia. Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease within 4 weeks prior to BL.
• Concomitant treatment with strong inductors or inhibitors of cytochrome P450 3A (e.g., Ketoconazole, Fluconazole, Rifampicin, Clarithromycin, St-John´s-wort).
• Strong CYP3A Inhibitors:
• Boceprevir
• Cobicistat
• Clarithromycin
• Conivaptan
• Grapefruit (fruit or juice)
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir/Ritonavir
• Mibefradil
• Nefazodone
• Nelfinavir

Where it is running

• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• The Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (enrolling)
• Groupe de Recherche en Maladies Osseuses (G.R.M.O.) Inc. — Québec, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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