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

NCT06454188 | Recruiting Phase 4 FDA Drug

• 1 other identifier: B24-033
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Psoriatic Arthritis; Spondyloarthritis, Axial

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the (SPARCC) MRI inflammation score (for SIJ and spine) at 12 weeks of therapy with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup

  12 weeks

Secondary Outcomes (6)

• Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at Week 12 with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup

  12 weeks

• Change from Baseline in BASDAI at Week 12 with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup

  12 weeks

• Change from baseline in the (SPARCC) MRI inflammation score (for SIJ and spine) at 12 weeks of therapy with upadacitinib vs placebo in the overall population (NSAID-IR, c-DMARD-IR and and bio-DMARD-IR)

  12 weeks

• Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at Week 12 with upadacitinib vs placebo in the overall population (NSAID-IR, c-DMARD-IR and and bio-DMARD-IR)

  12 weeks

• Change from Baseline in BASDAI at Week 12 with upadacitinib vs placebo in the overall population (NSAID-IR, c-DMARD-IR and and bio-DMARD-IR)

  12 weeks

Study Arms (2)

Upadacitinib

EXPERIMENTAL

Participants randomized to this arm will receive Upadacitinib 15 mg tablets, once per day, for 12 weeks.

Drug: Upadacitinib 15 MG [Rinvoq]

Placebo

PLACEBO COMPARATOR

Participants randomized to this arm will receive matching placebo tablets with no active ingredients, once per day, for 12 weeks.

Drug: Placebo

Interventions

Upadacitinib 15 MG [Rinvoq] DRUG

15mg tablet once per day.

Also known as: Rinvoq

Upadacitinib

Placebo DRUG

15mg tablet once per day.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• If subjects are currently taking bioDMARD therapy, they may be recruited after an appropriate wash-out period of bioDMARD prior to the screening MRI. Prior exposure to a bioDMARD is allowed for no more than 75 subjects, and prior exposure to a 2nd bioDMARD is allowed for no more than 30 subjects (one bioDMARD must include TNFi for US patients). Washout periods are as follows: 4 weeks for Etanercept, 8 weeks for Infliximab, 10 weeks for Adalimumab, Golimumab, Certolizumab and Ixekizumab, 12 weeks for Ustekinumab, Secukinumab, Guselkumab, and Abatacept, and 20 weeks for Risankizumab. However, subjects should not stop their previous successful biological therapy only to be included in this study. For patients intolerant to bioDMARD and not on such treatment a washout period may not be necessary.
• 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

Sponsors & Collaborators

• CARE ARTHRITIS LTD.: lead
• AbbVie: collaborator

Study Sites (4)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

DM Clinical Research

Tomball, Texas, 77377, United States

RECRUITING

The Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 7W9, Canada

NOT YET RECRUITING

Groupe de Recherche en Maladies Osseuses (G.R.M.O.) Inc.

Québec, Quebec, G1V 3M7, Canada

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic; Axial Spondyloarthritis

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Ankylosis

Study Officials

• Walter Maksymowych, Dr.

  CARE ARTHRITIS LTD.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Carapellucci

CONTACT

5874009524; amanda.carapellucci@carearthritis.com

Rana Dadashova

CONTACT

5874009524; rana.dadashova@careathritis.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

US (2); CA (2)