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Janus Kinase (JAK) Inhibitor

Upadacitinib for Psoriatic Arthritis (SELECT - PsA 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
Participant has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria
Must not have
Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Pivotal Trial

Summary

This trial is comparing the efficacy, safety, and tolerability of two doses of upadacitinib (15 mg and 30 mg) to placebo for the treatment of psoriatic arthritis. The trial will consist of two periods: Period 1 will compare the three groups of participants and Period 2 will evaluate the long-term safety, tolerability and efficacy of the two doses of upadacitinib.

Who is the study for?
This trial is for adults with moderately to severely active psoriatic arthritis who didn't respond well or couldn't tolerate at least one biologic DMARD. They must have at least 3 tender and swollen joints, a diagnosis of PsA for over 6 months, and meet specific criteria. People taking more than two non-biologic DMARDs or any JAK inhibitors can't join.
What is being tested?
The study tests the effectiveness of Upadacitinib (15 mg or 30 mg daily) compared to a placebo in improving symptoms of psoriatic arthritis. The first period assesses short-term effects while the second looks at long-term safety and benefits for those who finish the first phase.
What are the potential side effects?
Upadacitinib may cause side effects such as infections, liver issues, blood clots, cholesterol changes, gastrointestinal problems, and allergic reactions. Long-term use will be monitored for additional side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have at least 3 tender and 3 swollen joints.
Select...
I have been diagnosed with Psoriatic Arthritis for at least 6 months.
Select...
I have been diagnosed with plaque psoriasis.
Select...
I tried a biologic drug for over 12 weeks without improvement or couldn't tolerate it.

Exclusion Criteria

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

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Secondary study objectives
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Score at Week 16
+7 more

Side effects data

From 2023 Phase 3 trial • 657 Patients • NCT03086343
24%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
ACUTE RESPIRATORY FAILURE
12%
RASH
12%
WEIGHT INCREASED
12%
INFLUENZA
12%
FALL
12%
ARTHRALGIA
12%
URINARY TRACT INFECTION
12%
MUSCLE SPASMS
12%
SINUSITIS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
OROPHARYNGEAL PAIN
12%
LIVER FUNCTION TEST INCREASED
6%
PARAESTHESIA
6%
DEHYDRATION
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
SWELLING
6%
HYPONATRAEMIA
6%
CONSTIPATION
6%
RHEUMATOID ARTHRITIS
6%
RHINORRHOEA
6%
LEUKOCYTOSIS
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
HIP FRACTURE
6%
VOMITING
6%
ORAL CANDIDIASIS
6%
STAPHYLOCOCCAL INFECTION
6%
HERPES ZOSTER
6%
PNEUMONIA
6%
FEELING HOT
6%
HEADACHE
6%
HAEMOGLOBIN DECREASED
6%
PHOTODERMATOSIS
6%
PATELLA FRACTURE
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
LIGAMENT RUPTURE
6%
PNEUMONIA BACTERIAL
6%
PERIPHERAL SWELLING
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%
SJOGREN'S SYNDROME
6%
DIZZINESS
6%
DYSPHAGIA
6%
INFECTIOUS PLEURAL EFFUSION
6%
OSTEOARTHRITIS
6%
ACUTE KIDNEY INJURY
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%
VULVOVAGINAL MYCOTIC INFECTION
6%
ACTINIC KERATOSIS
6%
DERMATITIS ALLERGIC
6%
ASTHMA
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
SEBORRHOEIC KERATOSIS
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: Upadacitinib 30 mgExperimental Treatment1 Intervention
Period 1: Participants receive upadacitinib 30 mg once daily for 56 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.
Group II: Upadacitinib 15 mgExperimental Treatment1 Intervention
Period 1: Participants receive upadacitinib 15 mg once daily for 56 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.
Group III: Placebo then Upadacitinib 15 mgPlacebo Group2 Interventions
Period 1: Participants receive placebo once daily for 24 weeks followed by upadacitinib 15 mg once daily for 32 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.
Group IV: Placebo then Upadacitinib 30 mgPlacebo Group2 Interventions
Period 1: Participants receive placebo once daily for 24 weeks followed by upadacitinib 30 mg once daily for 32 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.
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
1,020 Previous Clinical Trials
519,486 Total Patients Enrolled
22 Trials studying Psoriatic Arthritis
108,263 Patients Enrolled for Psoriatic Arthritis
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
100,979 Total Patients Enrolled
11 Trials studying Psoriatic Arthritis
13,428 Patients Enrolled for Psoriatic Arthritis

Media Library

Upadacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03104374 — Phase 3
Psoriatic Arthritis Research Study Groups: Placebo then Upadacitinib 15 mg, Upadacitinib 30 mg, Placebo then Upadacitinib 30 mg, Upadacitinib 15 mg
Psoriatic Arthritis Clinical Trial 2023: Upadacitinib Highlights & Side Effects. Trial Name: NCT03104374 — Phase 3
Upadacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03104374 — Phase 3
~76 spots leftby Nov 2025
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