Your session is about to expire
← Back to Search
Monoclonal Antibodies
Ustekinumab approximately 6 mg/kg (IV) for Crohn's Disease (POWER Trial)
Phase 3
Waitlist Available
Research Sponsored by Janssen-Cilag Ltd.
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 baseline, weeks 8, 16, 24
Awards & highlights
POWER Trial Summary
This trial will test the effectiveness of giving a higher dose of the drug ustekinumab to people who have stopped responding to the usual dose.
POWER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 8, 16, 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 8, 16, 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Clinical Response at Week 16
Secondary outcome measures
Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST])
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate)
Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine)
+14 moreSide effects data
From 2023 Phase 3 trial • 215 Patients • NCT0378237621%
Crohn's Disease
11%
COVID-19
7%
Headache
5%
Abdominal Pain
5%
Upper Respiratory Tract Infection
4%
Influenza
4%
Back Pain
3%
Urinary Tract Infection
3%
Anaemia
3%
Nasopharyngitis
3%
Arthralgia
2%
Gastrooesophageal Reflux Disease
2%
Gastroenteritis
2%
Pyrexia
2%
Abdominal Pain Upper
2%
Sinusitis
2%
Dizziness
2%
Depression
2%
Vomiting
2%
Abdominal Discomfort
2%
Dyspepsia
2%
Haemorrhoids
2%
Pregnancy
2%
Heavy Menstrual Bleeding
2%
Influenza Like Illness
2%
Insomnia
1%
Ligament Rupture
1%
Dehydration
1%
Oropharyngeal Pain
1%
Dizziness Postural
1%
Acute Myocardial Infarction
1%
Tooth Abscess
1%
Rash
1%
Vaccination Complication
1%
Anal Abscess
1%
Carotid Arteriosclerosis
1%
Small Intestinal Stenosis
1%
Eye Irritation
1%
Toothache
1%
Seasonal Allergy
1%
Abscess Soft Tissue
1%
Hypoalbuminaemia
1%
Iron Deficiency
1%
Asthma
1%
Epistaxis
1%
Pruritus
1%
Urticaria
1%
Affective Disorder
1%
Ophthalmic Migraine
1%
Pain in Jaw
1%
Diabetes Mellitus
1%
Vertigo
1%
Abdominal Tenderness
1%
Nausea
1%
Clostridium Difficile Infection
1%
Gastrointestinal Infection
1%
Pharyngitis Streptococcal
1%
Procedural Pain
1%
Dyspnoea
1%
Nasal Congestion
1%
Acne
1%
Lymphopenia
1%
Arthritis
1%
Hypophosphataemia
1%
Abortion Spontaneous
1%
Eosinophilic Oesophagitis
1%
Blood Creatinine Increased
1%
Restlessness
1%
Cough
1%
Productive Cough
1%
Dermatitis
1%
Intertrigo
1%
Proctalgia
1%
Tonsillar Disorder
1%
Faecaloma
1%
Iron Deficiency Anaemia
1%
Haematochezia
1%
Injection Site Erythema
1%
Pollakiuria
1%
Dermal Cyst
1%
Atrial Fibrillation
1%
Ear Pain
1%
Tinnitus
1%
Food Poisoning
1%
Infection
1%
Subileus
1%
Small Intestinal Obstruction
1%
Gamma-Glutamyltransferase Increased
1%
Muscle Contracture
1%
Rheumatic Disorder
1%
Bronchitis
1%
Infected Fistula
1%
Spondylitis
1%
Vitamin D Decreased
1%
Vitamin D Deficiency
1%
Osteoarthritis
1%
Uveitis
1%
Migraine
1%
Eczema
1%
Tendon Rupture
1%
Hypercholesterolaemia
1%
Abdominal Distension
1%
Anal Fistula
1%
Psoriasis
1%
Cholestasis
1%
Lower Respiratory Tract Infection
1%
Foot Fracture
1%
Pituitary Tumour Benign
1%
Neck Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: Ustekinumab (IV Re-induction)
Group 2: Ustekinumab (Continuous q8w SC Maintenance)
POWER Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1: Ustekinumab (IV re-induction)Experimental Treatment3 Interventions
Participants who experience a secondary loss of response (LoR) to 90 mg ustekinumab maintenance treatment, administered subcutaneously every 8 weeks (q8w) will receive a weight-tiered based ustekinumab IV re-induction dose of approximately 6 mg/kg and matching placebo subcutaneously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.
Group II: Group 2: Ustekinumab (Continuous q8w SC maintenance)Active Control2 Interventions
Participants who experience a secondary LoR to 90 mg ustekinumab maintenance treatment, administered subcutaneously q8w will receive ustekinumab 90 mg subcutaneously and matching placebo intravenously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ustekinumab approximately 6 mg/kg (IV)
2018
Completed Phase 3
~220
Placebo (SC)
2010
Completed Phase 3
~420
Ustekinumab 90 mg (SC) Group 1
2018
Completed Phase 3
~220
Find a Location
Who is running the clinical trial?
Janssen-Cilag Ltd.Lead Sponsor
96 Previous Clinical Trials
48,089 Total Patients Enrolled
Janssen-Cilag Ltd. Clinical TrialStudy DirectorJanssen-Cilag Ltd.
18 Previous Clinical Trials
12,938 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do we have any other similar cases to compare with this Ustekinumab clinical trial?
"Currently, 35 clinical trials are studying the efficacy of Ustekinumab approximately 6 mg/kg (IV). Of those, 18 are in Phase 3. Although the majority of trials for Ustekinumab approximately 6 mg/kg (IV) are based in Gdansk, Pomorskie, there are 2789 locations running trials for this treatment."
Answered by AI
Are new patients being enrolled in this program at this time?
"This study, as indicated by clinicaltrials.gov, is not looking for any more patients as it is not an active trial. However, this study was posted on December 20th, 2018 and was edited most recently on October 12th, 2020. There are 291 other trials that are currently enrolling participants."
Answered by AI
What are some of the key benefits of Ustekinumab 6 mg/kg (IV)?
"The medication ustekinumab can be used to treat adrenal cortex hormones, psoriasis, and patients that have an inadequate response to one or more tnf antagonist therapies. The standard dosage is 6 mg/kg (IV)."
Answered by AI
How many patients are currently enrolled in this research project?
"Unfortunately, this study is no longer recruiting patients. Although, there are presently 256 clinical trials actively looking for participants with ileocolitis and 35 trials for Ustekinumab approximately 6 mg/kg (IV) that are still recruiting."
Answered by AI
What are the risks associated with a Ustekinumab dosage of 6 mg/kg (IV)?
"Ustekinumab approximately 6 mg/kg (IV) is safe according to our team's 3-point scale because Phase 3 trials have some data to suggest efficacy and repeated rounds of data affirming safety."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger