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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through week 240

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%

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

VULVOVAGINAL MYCOTIC INFECTION

LIGAMENT RUPTURE

DEHYDRATION

NASAL CONGESTION

PULMONARY EMBOLISM

HYPONATRAEMIA

CONSTIPATION

RHINORRHOEA

LEUKOCYTOSIS

BLOOD PRESSURE INCREASED

COUGH

BONE CONTUSION

HIP FRACTURE

VOMITING

PERIPHERAL SWELLING

STAPHYLOCOCCAL INFECTION

ORAL CANDIDIASIS

PNEUMONIA

FEELING HOT

HEADACHE

HAEMOGLOBIN DECREASED

PHOTODERMATOSIS

RHEUMATOID ARTHRITIS

PARAESTHESIA

PNEUMONIA BACTERIAL

STOMATITIS

SKIN LACERATION

HYPOKALAEMIA

GLAUCOMA

FEMUR FRACTURE

BACTERIAL SEPSIS

CHEST PAIN

FATIGUE

ATRIOVENTRICULAR BLOCK FIRST DEGREE

CANDIDA INFECTION

TACHYCARDIA

COVID-19

CATARACT

INFECTIOUS PLEURAL EFFUSION

SJOGREN'S SYNDROME

DIZZINESS

DYSPHAGIA

SWELLING

SEBORRHOEIC KERATOSIS

ACUTE KIDNEY INJURY

CHRONIC OBSTRUCTIVE PULMONARY DISEASE

HERPES ZOSTER

OSTEOARTHRITIS

NAUSEA

NON-CARDIAC CHEST PAIN

RHINITIS

BLOOD CREATINE PHOSPHOKINASE INCREASED

OSTEOPENIA

INSOMNIA

PRURITUS

SUPRAVENTRICULAR TACHYCARDIA

SCRATCH

EYE HAEMATOMA

ERYTHEMA

COSTOCHONDRITIS

ACTINIC KERATOSIS

DERMATITIS ALLERGIC

ASTHMA

PATELLA FRACTURE

FLANK PAIN

SCIATICA

ANAEMIA

BILIARY COLIC

DERMATITIS CONTACT

HEPATIC STEATOSIS

DRUG HYPERSENSITIVITY

HERPES SIMPLEX

LOCALISED INFECTION

PHARYNGITIS

DIABETES MELLITUS

VITAMIN D DEFICIENCY

BACK PAIN

100%

80%

60%

40%

20%

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