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Janus Kinase (JAK) Inhibitor

Upadacitinib for Crohn's Disease

Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented diagnosis of CD prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia, and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of CD must be available
Moderate to severe Crohn's disease (CD) defined as Pediatric Crohn's Disease Activity Index (PCDAI) > 30 and endoscopic evidence of mucosal inflammation as documented by a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) of > 6 (or SES-CD of > 4 for isolated ileal disease) excluding the presence of a narrowing component
Must not have
History of a diagnosis of CD prior to 2 years of age
History of current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic inflammatory bowel disease; fulminant colitis or toxic megacolon; gastrointestinal perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for gastrointestinal perforation per investigator judgment including history of volvulus and/or intussusception (telescoping of bowels)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through week 156
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test the safety and effectiveness of a drug called Upadacitinib in treating children aged 2 to 18 years old with moderate to severe Crohn's Disease who have not responded

Who is the study for?
This trial is for children aged 2-18 with moderate to severe Crohn's Disease who haven't had success with, or can't use, standard treatments like corticosteroids and biologics. They must weigh at least 10 kg and have a confirmed diagnosis of CD with specific endoscopic findings.
What is being tested?
The trial tests Upadacitinib's safety and effectiveness in these kids over two periods: first a known-dose phase for 12 weeks, then a year where the dose is unknown to them. It ends with an open-label extension for up to three years.
What are the potential side effects?
Possible side effects include digestive issues, infections due to immune system suppression, liver problems, blood disorders, allergic reactions and others not listed here. Regular check-ups will monitor any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have Crohn's disease confirmed by a recent colonoscopy and biopsy.
Select...
My Crohn's disease is moderate to severe with a PCDAI score over 30 and confirmed inflammation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I was diagnosed with CD before I turned 2 years old.
Select...
I have a history of severe bowel diseases or conditions.
Select...
I have Crohn's disease with complications like abscesses, strictures, or multiple surgeries.
Select...
I have been diagnosed with a primary immune deficiency.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through week 156
This trial's timeline: 3 weeks for screening, Varies for treatment, and through week 156 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Achievement of endoscopic response at Week 64 in participants who achieved clinical response per PCDAI at Week 12.
Number of Participants with Adverse Events
Percentage of participants who achieved clinical response per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12, with clinical remission per the PCDAI at Week 64
Secondary study objectives
Achievement of clinical remission per PCDAI
Achievement of clinical response per PCDAI
Achievement of corticosteroid (CS)-free clinical remission per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12
+3 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%
OROPHARYNGEAL PAIN
12%
ARTHRALGIA
12%
SINUSITIS
12%
MUSCLE SPASMS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
LIVER FUNCTION TEST INCREASED
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
PATELLA FRACTURE
6%
ASTHMA
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%
COSTOCHONDRITIS
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
6%
PHOTODERMATOSIS
6%
PNEUMONIA BACTERIAL
6%
STOMATITIS
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%
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%
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%
ACTINIC KERATOSIS
6%
DERMATITIS ALLERGIC
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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Period 2: Open Label Long-Term Extension Phase Cohort 3Experimental Treatment1 Intervention
Participants who did not achieve clinical response per PCDAI at Week 12 of Period 1 will receive an extended treatment with open-label upadacitinib Dose C daily for an additional 12 weeks. If they are responders after 12 weeks extended treatment, they will continue, otherwise they may be discontinued at the discretion of the investigator
Group II: Period 2: Open Label Long-Term Extension Phase Cohort 2Experimental Treatment1 Intervention
Participants who were receiving rescue therapy with open-label upadacitinib Dose C during maintenance phase in Period 1 and completed the Week 64 visit will continue to receive upadacitinib Dose C daily for up to 156 weeks.
Group III: Period 2: Open Label Long-Term Extension Phase Cohort 1Experimental Treatment1 Intervention
Participants receiving double-blind maintenance therapy with upadacitinib Dose B or upadacitinib Dose C daily in Period 1 who complete the Week 64 visit will receive upadacitinib Dose B daily for up to 156 weeks.
Group IV: Period 1: Open Label Induction Phase (Dose A)Experimental Treatment1 Intervention
All participants in the open label induction phase of Period 1 will receive upadacitinib Dose A for 12 weeks based on body weight.
Group V: Period 1: Double-Blind Maintenance Phase (Dose C)Experimental Treatment1 Intervention
Clinical responders per PCDAI at the end of open label induction phase of Period 1 will be randomly assigned to receive either upadacitinib Dose C or B for 52 weeks (oral solution dose will be based on body weight)
Group VI: Period 1: Double-Blind Maintenance Phase (Dose B)Experimental Treatment1 Intervention
Clinical responders per PCDAI at the end of open label induction phase of Period 1 will be randomly assigned to receive Dose B or C for 52 weeks (oral solution dose will be based on body weight)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
2014
Completed Phase 3
~11250

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,029 Previous Clinical Trials
521,420 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
450 Previous Clinical Trials
161,906 Total Patients Enrolled
~73 spots leftby Jun 2027
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