A Pragmatic Trial of Interleukin-17 Inhibition Versus Janus Kinase Inhibition After Tumor Necrosis Factor-alpha Inhibitor Failure in Axial Spondyloarthritis

NCT07770646 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: HSC-MS-26-0457
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the feasibility of conducting a pragmatic trial of IL-17i versus JAKi in adults with axial spondyloarthritis (axSpA) who have failed at least one tumor necrosis factor-alpha inhibitor (TNFi), to estimate the effectiveness of IL-17i versus JAKi at 16 weeks and to determine additional effectiveness measures, safety, and treatment persistence of IL-17i versus JAKi

Conditions

Axial Spondyloarthritis (AxSpA)

Keywords

comparative effectiveness; axial spondyloarthritis; secukinumab; upadacitinib

Outcome Measures

Primary Outcomes (4)

• Feasibility as determined by enrollment of ≥60% of eligible patients

  end of treatment (week 16)

• Feasibility as determined by ≥80% retention of randomized participants

  end of treatment (week 16)

• Feasibility as determined by ≥90% completeness of primary clinical data

  end of treatment (week 16)

• Change in the Ankylosing Spondylitis Disease Activity Score (ASDAS) reported as a mean (SD)

  This is a 4 item questionnaire and one lab result (CRP). The first 4 questions are scored from 0-10. The result is a single numerical score, typically ranging from about 0 to 6, with higher scores indicating more active disease.

  Baseline, week 16

Secondary Outcomes (36)

• Number of patients showing an improvement of ≥1.1 and ≥2.0 on the ASDAS score

  end of treatment (week 16)

• Percentage of patients showing an improvement of ≥1.1 and ≥2.0 on the ASDAS score

  end of treatment (week 16)

• Number of participants in the different categories of disease activity as assessed by the ASDAS

  end of treatment (week 16)

• Percentage of participants in the different categories of disease activity as assessed by the ASDAS

  end of treatment (week 16)

• Number of participants that have an ASDAS score of <2.1 and ≥2.1

  end of treatment (week 16)

Study Arms (2)

Secukinumab (IL-17i )

EXPERIMENTAL

Drug: Secukinumab (IL-17i )

Upadacitinib (JAKi)

EXPERIMENTAL

Drug: Upadacitinib (JAKi)

Interventions

Secukinumab (IL-17i ) DRUG

Secukinumab is a fully humanized monoclonal antibody targeting interleukin-17A. Secukinumab will be given as a prefilled syringe or autoinjector for subcutaneous administration. Dosing is 150 mg subcutaneously at weeks 0, 1, 2, 3, and 4 followed by 150mg every 4 weeks thereafter for a total of 16 weeks.

Secukinumab (IL-17i )

Upadacitinib (JAKi) DRUG

Upadacitinib is an oral selective inhibitor of janus kinase 1 (JAK1). Participants will take upadacitinib 15mg orally once daily for 16 weeks.

Upadacitinib (JAKi)

Eligibility Criteria

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

You may qualify if:

• fulfill ASAS classification criteria for axSpA and/or modified New York classification criteria for AS
• Active axSpA (ASDAS ≥ 2.1 and/or BASDAI ≥ 4)
• Failure of or intolerance to ≥1 TNF
• Participants of reproductive potential must agree to use any form of effective contraception during the study period, in accordance with standard clinical practice and FDA labeling for the assigned study medication
• Ability to provide informed consent

You may not qualify if:

• Previously received an IL-17i or JAKi
• Active infection requiring antimicrobials
• Contraindications to either treatment arm:
• Inflammatory bowel disease (IBD)- Crohn's disease or Ulcerative Colitis
• Active cancer or cancer remission within the past 3 years (apart from non-melanoma skin cancer (NMSC) and cervical intraepithelial neoplasia (CIN)
• History of stroke, heart attack, or blood clots (venous or arterial)
• Cirrhosis
• End-stage renal disease (GFR \<15) or dialysis
• Human Immunodeficiency Virus (HIV) positive
• Pregnant or lactating
• Concomitant use of other biologic or targeted synthetic disease-modifying anti-rheumatic drug (tsDMARD) therapy

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

secukinumab; upadacitinib

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Savannah M Bowman, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Savannah M Bowman, MD

CONTACT

(713) 500-6883; Savannah.Bowman@uth.tmc.edu

Mark C Hwang, MD

CONTACT

(713) 500-6597; Mark.C.Hwang@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 18, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): September 15, 2029
• Last Updated: September 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)