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Janus Kinase Inhibitor

Upadacitinib Maintenance Therapy for Crohn's Disease (U-ENDURE 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through week 240
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new Crohn's disease drug to see if it is effective and safe.

Who is the study for?
This trial is for adults with Crohn's Disease who showed improvement in previous studies (M14-431 or M14-433) and completed certain study procedures. Participants can still join if their final endoscopy was missed due to COVID-19.
What is being tested?
The trial tests the long-term effectiveness and safety of Upadacitinib, a pill that targets specific proteins involved in inflammation, compared to a placebo in maintaining Crohn's Disease treatment effects.
What are the potential side effects?
Upadacitinib may cause side effects like infections, headaches, high blood pressure, nausea, and potential liver issues. The severity of side effects varies from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through week 240
This trial's timeline: 3 weeks for screening, Varies for treatment, and through week 240 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Adverse Events
Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)
Sub-Study 1: Percentage of Participants with Endoscopic Response
Secondary study objectives
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100)
+8 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%
URINARY TRACT INFECTION
12%
INFLUENZA
12%
FALL
12%
ARTHRALGIA
12%
WEIGHT INCREASED
12%
SINUSITIS
12%
MUSCLE SPASMS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
LIVER FUNCTION TEST INCREASED
12%
OROPHARYNGEAL PAIN
6%
DEHYDRATION
6%
PNEUMONIA BACTERIAL
6%
HEPATIC STEATOSIS
6%
ASTHMA
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
HYPONATRAEMIA
6%
CONSTIPATION
6%
RHINORRHOEA
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%
COSTOCHONDRITIS
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
6%
PHOTODERMATOSIS
6%
LEUKOCYTOSIS
6%
TACHYCARDIA
6%
HYPOKALAEMIA
6%
STOMATITIS
6%
PATELLA FRACTURE
6%
ACTINIC KERATOSIS
6%
GLAUCOMA
6%
BACTERIAL SEPSIS
6%
CHEST PAIN
6%
FATIGUE
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CANDIDA INFECTION
6%
COVID-19
6%
CATARACT
6%
INFECTIOUS PLEURAL EFFUSION
6%
SJOGREN'S SYNDROME
6%
DYSPHAGIA
6%
SWELLING
6%
ACUTE KIDNEY INJURY
6%
HERPES ZOSTER
6%
OSTEOARTHRITIS
6%
NAUSEA
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
FEMUR FRACTURE
6%
LIGAMENT RUPTURE
6%
SKIN LACERATION
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
SEBORRHOEIC KERATOSIS
6%
EYE HAEMATOMA
6%
INSOMNIA
6%
ERYTHEMA
6%
PRURITUS
6%
DERMATITIS ALLERGIC
6%
BACK PAIN
6%
DIZZINESS
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
OSTEOPENIA
6%
PHARYNGITIS
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

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

9Treatment groups
Experimental Treatment
Group I: Substudy 2: Cohort 5 Upadacitinib Dose BExperimental Treatment1 Intervention
This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose B for 240 weeks.
Group II: Substudy 2: Cohort 5 Upadacitinib Dose AExperimental Treatment1 Intervention
This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose A for 240 weeks.
Group III: Substudy 2: Cohort 5 PlaceboExperimental Treatment1 Intervention
This is a long-term extension group which includes participants who complete Substudy 1 and will receive placebo for 240 weeks.
Group IV: Substudy 2: Cohort 4 Upadacitinib Dose BExperimental Treatment1 Intervention
This is a long-term extension group which includes participants who achieved clinical response in the open-label extended treatment period of study M14-431 and will receive upadacitinib dose B for 240 weeks.
Group V: Substudy 1: Cohort 3 Upadacitinib Dose BExperimental Treatment1 Intervention
This is a maintenance group which includes participants who achieved clinical response to upadacitinib from the extended treatment period of studies M14-431 and M14-433 and will receive upadacitinib Dose B for 52 Weeks.
Group VI: Substudy 1: Cohort 2 PlaceboExperimental Treatment1 Intervention
This is a maintenance group which includes participants who received double-blind placebo in studies M14-431 and M14-433 and achieved clinical response will continue to receive blinded placebo for 52 Weeks.
Group VII: Substudy 1: Cohort 1 Upadacitinib Dose BExperimental Treatment1 Intervention
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose B for 52 weeks.
Group VIII: Substudy 1: Cohort 1 Upadacitinib Dose AExperimental Treatment1 Intervention
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose A for 52 weeks.
Group IX: Substudy 1: Cohort 1 PlaceboExperimental Treatment1 Intervention
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive placebo for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo for Upadacitinib
2020
Completed Phase 3
~720
Upadacitinib
2014
Completed Phase 3
~11250

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,035 Previous Clinical Trials
522,297 Total Patients Enrolled
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
100,874 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
456 Previous Clinical Trials
162,946 Total Patients Enrolled

Media Library

Upadacitinib (Janus Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03345823 — Phase 3
Crohn's Disease Research Study Groups: Substudy 1: Cohort 3 Upadacitinib Dose B, Substudy 1: Cohort 1 Placebo, Substudy 1: Cohort 2 Placebo, Substudy 2: Cohort 5 Upadacitinib Dose B, Substudy 2: Cohort 5 Upadacitinib Dose A, Substudy 2: Cohort 4 Upadacitinib Dose B, Substudy 1: Cohort 1 Upadacitinib Dose A, Substudy 1: Cohort 1 Upadacitinib Dose B, Substudy 2: Cohort 5 Placebo
Crohn's Disease Clinical Trial 2023: Upadacitinib Highlights & Side Effects. Trial Name: NCT03345823 — Phase 3
Upadacitinib (Janus Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03345823 — Phase 3
~212 spots leftby Sep 2027
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