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Janus Kinase (JAK) Inhibitor
Upadacitinib for Ulcerative Colitis
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will assess the safety and effectiveness of Upadacitinib in treating pediatric UC. It will involve 2 periods, 8 wk induction, 44 wk double-blind maintenance, 260 wk open-label extension. 110 participants worldwide will take part.
Who is the study for?
This trial is for pediatric patients with moderate to severely active Ulcerative Colitis who haven't responded well to other treatments like corticosteroids, immunosuppressants, or biologics. They must have certain levels of disease activity and inflammation in the colon. Pregnant or breastfeeding individuals, or those planning pregnancy during the study period are excluded, as are those previously treated with JAK inhibitors.
What is being tested?
The trial tests Upadacitinib's safety and effectiveness in children with UC over two periods: an initial 8-week phase where everyone knows they're getting the drug followed by a 44-week phase where participants don't know their dose. This leads into a long-term extension for monitoring. The treatment involves daily oral tablets or solution.
What are the potential side effects?
While not explicitly listed here, common side effects of Upadacitinib may include infections due to immune system suppression, increased cholesterol levels, liver enzyme elevations indicating potential liver injury, gastrointestinal perforations (holes), and allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
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 Achieving AMS Clinical Remission Among Week 8 Responders per AMS (Period 1)
Percentage of Participants Achieving Adapted Mayo score (AMS) Clinical Remission (Period 1)
Secondary study objectives
Percentage of Participants Achieving AMS Clinical Remission Among Week 8 Remitters per AMS (Period 1)
Percentage of Participants Achieving AMS Clinical Response (Period 1)
Percentage of Participants Achieving AMS Clinical Response Among Week 8 Responders per AMS (Period 1)
+6 moreSide effects data
From 2023 Phase 3 trial • 657 Patients • NCT0308634324%
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%
VULVOVAGINAL MYCOTIC INFECTION
6%
LIGAMENT RUPTURE
6%
PARAESTHESIA
6%
DEHYDRATION
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
PERIPHERAL SWELLING
6%
SEBORRHOEIC KERATOSIS
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%
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%
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%
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
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
5Treatment groups
Experimental Treatment
Group I: Period 2- Open Label Long Term Extension Phase Arm BExperimental Treatment1 Intervention
Clinical non-responders in US after Period 1 induction phase or clinical responders with loss of response during maintenance phase will receive upadacitinib Dose B daily for up to 260 weeks in OLE Period 2.
Group II: Period 2- Open Label Long Term Extension Phase Arm AExperimental Treatment1 Intervention
Clinical non-responders outside of US after Period 1 induction phase will receive upadacitinib Dose A daily for 8 week extended induction phase in open label long term extension (OLE) Period 2. Clinical responders from extended induction phase in OLE will receive upadacitinib Dose B daily for up to 252 weeks in OLE period 2.
Group III: Period 2- Long Term Extension Phase Arm CExperimental Treatment1 Intervention
Clinical responders who complete Period 1 through Week 52 will receive upadacitinib Dose C daily for up to 260 weeks in OLE Period 2.
Group IV: Period 1- Open Label Induction PhaseExperimental Treatment1 Intervention
All participants in open label induction phase of Period 1 will receive upadacitinib Dose A for 8 weeks based on body weight.
Group V: Period 1- Double Blind Maintenance PhaseExperimental Treatment1 Intervention
Clinical responders at the end of open label induction phase of Period 1 will be randomly assigned to receive either upadacitinib Dose B or Dose C for 44 weeks 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
1,022 Previous Clinical Trials
520,132 Total Patients Enrolled
31 Trials studying Colitis
21,100 Patients Enrolled for Colitis
ABBVIE INC.Study DirectorAbbVie
443 Previous Clinical Trials
160,555 Total Patients Enrolled
18 Trials studying Colitis
17,142 Patients Enrolled for Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with JAK inhibitors before.My ulcerative colitis is active with moderate to severe symptoms.I haven't responded well to standard treatments like steroids, immunosuppressants, or biologics.I am not pregnant, breastfeeding, nor planning to become pregnant soon.
Research Study Groups:
This trial has the following groups:- Group 1: Period 1- Open Label Induction Phase
- Group 2: Period 1- Double Blind Maintenance Phase
- Group 3: Period 2- Open Label Long Term Extension Phase Arm A
- Group 4: Period 2- Open Label Long Term Extension Phase Arm B
- Group 5: Period 2- Long Term Extension Phase Arm C
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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