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Janus Kinase (JAK) Inhibitor

Upadacitinib for Axial Spondyloarthritis (SELECT-AXIS 2 Trial)

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Study 1 and Study 2: Participant must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and a Patient's Assessment of Total Back Pain score ≥ 4 based on a 0 - 10 numerical rating scale at the Screening and Baseline Visits.
Study 1: Must have a clinical diagnosis of ankylosing spondylitis (AS) and meet the modified New York Criteria for AS, Must not have total spinal ankylosis Must have been previously exposed to 1 or 2 bDMARDs (at least 1 tumor necrosis factor [TNF] inhibitor or 1 interleukin [IL]-17 inhibitor [IL-17i]), and must have discontinued the bDMARD therapy due to either lack of efficacy (after at least 12 weeks of treatment with a bDMARD at an adequate dose) or intolerance (irrespective of treatment duration). Prior exposure to two bDMARDs was allowed for no more than 30% of patients; among patients with prior exposure to two bDMARDs, a lack of efficacy to one bDMARD and intolerance to another was permitted, but a patient could not have a lack of efficacy to two bDMARDs
Must not have
Must not have been exposed to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib [Rinvoq®], tofacitinib [Xeljanz®], baricitinib [Olumiant®], filgotinib, ruxolitinib [Jakafi®], abrocitinib [PF-04965842], and peficitinib [Smyraf®]).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24, week 32, week 40, and week 52
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Pivotal Trial

Summary

This trial has two parts. In the first part, people with active axial spondyloarthritis who haven't responded well to other treatments will be given upadacitinib or a placebo. In the second part, people with non-radiographic axial spondyloarthritis will be given the drug or a placebo. The objective is to see if upadacitinib is effective in reducing signs and symptoms, and if it is safe and well-tolerated.

Who is the study for?
Adults with active axial spondyloarthritis, including those who didn't respond well to certain rheumatic disease treatments (bDMARDs), can join this trial. Participants must have a specific level of disease activity and back pain, and not be fully fused in the spine due to ankylosis. They shouldn't have used JAK inhibitors before or be allergic to study drug ingredients.
What is being tested?
The trial is testing Upadacitinib's effectiveness compared to a placebo in reducing symptoms for two groups: one with ankylosing spondylitis (AS) that didn’t respond well to bDMARDs, and another with non-radiographic axial spondyloarthritis (nr-axSpA). It also looks at how safe and tolerable the drug is over time.
What are the potential side effects?
While not specified here, common side effects of drugs like Upadacitinib may include infections, headaches, high blood pressure, nausea, and potential liver enzyme elevations. Each person’s reaction can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My back pain and ankylosing spondylitis symptoms are moderate to severe.
Select...
I have ankylosing spondylitis, tried 1-2 bDMARDs without success or couldn't tolerate them.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have never taken any JAK inhibitor medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24, week 32, week 40, and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24, week 32, week 40, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14
Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14
Secondary study objectives
Study 1: Change From Baseline in ASAS Health Index at Week 14
Ankylosing spondylitis
Ankylosing spondylitis
+32 more

Side effects data

From 2023 Phase 3 trial • 657 Patients • NCT03086343
24%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
RASH
12%
ACUTE RESPIRATORY FAILURE
12%
WEIGHT INCREASED
12%
URINARY TRACT INFECTION
12%
INFLUENZA
12%
FALL
12%
ARTHRALGIA
12%
SINUSITIS
12%
MUSCLE SPASMS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
OROPHARYNGEAL PAIN
12%
LIVER FUNCTION TEST INCREASED
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
LIGAMENT RUPTURE
6%
DEHYDRATION
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
HYPONATRAEMIA
6%
CONSTIPATION
6%
RHINORRHOEA
6%
LEUKOCYTOSIS
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
HIP FRACTURE
6%
VOMITING
6%
PERIPHERAL SWELLING
6%
STAPHYLOCOCCAL INFECTION
6%
ORAL CANDIDIASIS
6%
PNEUMONIA
6%
FEELING HOT
6%
HEADACHE
6%
HAEMOGLOBIN DECREASED
6%
PHOTODERMATOSIS
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
6%
PNEUMONIA BACTERIAL
6%
FEMUR FRACTURE
6%
STOMATITIS
6%
SKIN LACERATION
6%
HYPOKALAEMIA
6%
GLAUCOMA
6%
BACTERIAL SEPSIS
6%
CHEST PAIN
6%
FATIGUE
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CANDIDA INFECTION
6%
TACHYCARDIA
6%
COVID-19
6%
CATARACT
6%
INFECTIOUS PLEURAL EFFUSION
6%
SJOGREN'S SYNDROME
6%
DIZZINESS
6%
DYSPHAGIA
6%
SWELLING
6%
SEBORRHOEIC KERATOSIS
6%
ACUTE KIDNEY INJURY
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
HERPES ZOSTER
6%
OSTEOARTHRITIS
6%
NAUSEA
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
OSTEOPENIA
6%
INSOMNIA
6%
PRURITUS
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
EYE HAEMATOMA
6%
ERYTHEMA
6%
COSTOCHONDRITIS
6%
ACTINIC KERATOSIS
6%
DERMATITIS ALLERGIC
6%
ASTHMA
6%
PATELLA FRACTURE
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
HEPATIC STEATOSIS
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
PHARYNGITIS
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
BACK PAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, Primary and 30 mg Cohorts: Abatacept
Period 1, Primary Cohort: Upadacitinib 15 mg QD

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Study 2: Upadacitinib 15 mgExperimental Treatment1 Intervention
Participants receive 15 mg upadacitinib orally once a day for 104 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).
Group II: Study 1: Upadacitinib 15 mgExperimental Treatment1 Intervention
Participants receive 15 mg upadacitinib orally once a day for 104 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).
Group III: Study 1: PlaceboPlacebo Group2 Interventions
Participants receive matching placebo for 14 weeks and then switch to receive 15 mg upadacitinib orally once a day for 90 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).
Group IV: Study 2: PlaceboPlacebo Group2 Interventions
Participants receive matching placebo for 52 weeks and then switch to receive 15 mg upadacitinib orally once a day for 52 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
FDA approved

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,023 Previous Clinical Trials
519,555 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
444 Previous Clinical Trials
160,041 Total Patients Enrolled

Media Library

Upadacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04169373 — Phase 3
Spondyloarthritis Research Study Groups: Study 1: Upadacitinib 15 mg, Study 2: Upadacitinib 15 mg, Study 1: Placebo, Study 2: Placebo
Spondyloarthritis Clinical Trial 2023: Upadacitinib Highlights & Side Effects. Trial Name: NCT04169373 — Phase 3
Upadacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04169373 — Phase 3
~124 spots leftby Nov 2025
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