A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
- Conditions
- Colitis, Ulcerative
- Interventions
- Registration Number
- NCT06260163
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Weight greater than or equal to (>=) 10 kilogram (kg) at the time of consent for screening
- A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC.
- Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore >= 2 as determined by a central review of the video of the endoscopy
- Medically stable based on physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
- Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids
- Have UC limited to the rectum only or to less than (<) 20 centimeter of the colon
- Presence of a stoma
- Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline
- Have severe colitis or have evidence of Crohn's Disease (CD)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double-blind Maintenance Phase: Guselkumab Dose Regimen 2 Guselkumab Subcutaneous At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their BW up to Week 56. Open-label Induction Phase: Guselkumab Intravenously (IV) Guselkumab Intravenous Participants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase. Double-blind Maintenance Phase: Guselkumab Dose Regimen 1 Guselkumab Subcutaneous At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their BW up to Week 56. Open-label Induction Phase: Guselkumab Subcutaneously (SC) Guselkumab Subcutaneous Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase. Open-label Maintenance Phase: Guselkumab SC Guselkumab Subcutaneous Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 56.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Clinical Remission at Week 56 Week 56 Percentage of participants with clinical remission as assessed by modified Mayo score at Week 56 among participants who were induction responders will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Clinical Remission at Week 12 Week 12 Percentage of participants with clinical remission at Week 12 as assessed by modified Mayo score will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12 Week 12 Percentage of participants with PUCAI remission at Week 12 will be reported. It comprises 6 scales and ranges between 0 and 85 points. The scales are abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (\<) 10 indicates remission.
Percentage of Participants with Symptomatic Remission at Week 12 Week 12 Percentage of participants with symptomatic remission at Week 12 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
Percentage of Participants with Symptomatic Remission at Week 56 Week 56 Percentage of participants with symptomatic remission at Week 56 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
Number of Participants with Incidence of Anti-guselkumab Antibodies Up to Week 68 Number of participants with anti-guselkumab antibodies for all study treatment regimens will be assessed.
Percentage of Participants with AEs Leading to Discontinuation of Study Intervention Up to Week 68 Percentage of participants with AEs leading to discontinuation of study intervention will be reported.
Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56 Week 56 Percentage of participants with corticosteroid-free clinical remission at Week 56 will be reported. Corticosteroid free clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline (Week 0), and not receiving corticosteroids for at least 8 weeks prior to Week 56
Percentage of Participants with Clinical Response at Week 12 Week 12 Percentage of participants with clinical response as assessed by modified Mayo score at Week 12 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent and \>= 2 points, with either a decrease from baseline in the rectal bleeding subscore of \>= 1 or a rectal bleeding subscore of 0 or 1.
Percentage of Participants with Clinical Response at Week 56 Week 56 Percentage of participants with clinical response as assessed by modified Mayo score at Week 56 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by \>= 30 percent and \>= 2 points, with either a decrease from baseline in the rectal bleeding subscore of \>= 1 or a rectal bleeding subscore of 0 or 1.
Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12 Week 56 Percentage of participants with symptomatic remission at Week 56 among participants who had symptomatic remission at Week 12 will be reported. Symptomatic remission score is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
European Union: Percentage of Participants with Endoscopic Healing at Week 12 Week 12 Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.
United States: Percentage of Participants With Endoscopic Improvement at Week 56 Week 56 Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.
European Union: Percentage of Participants With Endoscopic Healing at Week 56 Week 56 Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.
Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56 Week 56 Percentage of participants histo-endoscopic mucosal healing per endoscopy subscore and histologic improvement at Week 56 will be reported. Histologic-endoscopic mucosal healing is defined as achieving a combination of histologic improvement and endoscopic improvement (US) or endoscopic healing (EU) (endoscopy subscore of 0 or 1).
Serum Concentration of Guselkumab During Induction Phase From Week 0 to Week 12 Serum samples will be analyzed to determine concentrations of guselkumab overtime.
United States: Percentage of Participants with Endoscopic Improvement at Week 12 Week 12 Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.
Percentage of Participants With PUCAI Remission at Week 56 Week 56 Percentage of participants with PUCAI remission at Week 56 will be reported. PUCAI comprises of 6 scales and ranges between 0 and 85 points. The scales are: abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (\<) 10 indicates remission.
Percentage of Participants Who Achieve Endoscopic Normalization at Week 56 Week 56 Percentage of participants who achieve endoscopic normalization with an endoscopy subscore of 0 at Week 56 will be reported.
Serum Concentration of Guselkumab During Maintenance Phase From Week 12 to Week 56 Serum samples will be analyzed to determine concentrations of guselkumab over time.
Percentage of Participants with Adverse Events (AEs) Up to Week 68 Percentage of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Percentage of Participants with Serious Adverse Events (SAEs) Up to Week 68 Percentage of participants with SAEs will be reported. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly.
Trial Locations
- Locations (61)
Children's Hospital Oakland
🇺🇸Oakland, California, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
NYU Langone Health
🇺🇸Lake Success, New York, United States
The Kids Research Institute Australia on behalf of the Centre for Child Health Research
🇦🇺Nedlands, Australia
Mater Hospital Brisbane Inflammatory Bowel Diseases
🇦🇺South Brisbane, Australia
The Children's Hospital at Westmead
🇦🇺Westmead, Australia
CHU Charleroi Chimay
🇧🇪Charleroi, Belgium
UZ Gent
🇧🇪Gent, Belgium
UZ Brussel
🇧🇪Jette, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Capital Institute of Pediatrics
🇨🇳Beijing, China
Peking University Third Hospital
🇨🇳Beijing, China
Changzhou No 2 Peoples Hospital
🇨🇳Changzhou City, China
The Childrens Hospital Zhejiang University School Of Medicine
🇨🇳Hangzhou, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Ruijin Hospital Shanghai Jiao Tong University
🇨🇳Shanghai, China
Shengjing Hospital Of China Medical University
🇨🇳Shenyang, China
Henan Children's Hospital, Zhengzhou Children's Hospital
🇨🇳ZhengZhou, China
Aarhus Universitetshospital
🇩🇰Aarhus N, Denmark
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
🇫🇷Bron cedex, France
Hopital Francois Mitterand
🇫🇷Dijon, France
CHRU Lille
🇫🇷Lille Cedex, France
APHP Hopital Robert Debre
🇫🇷Paris, France
CHU Toulouse
🇫🇷Toulouse, France
ASST Papa Giovanni XXIII Bergamo
🇮🇹Bergamo, Italy
Azienda USL di Bologna - Ospedale Maggiore
🇮🇹Bologna, Italy
AOU Meyer
🇮🇹Firenze, Italy
Ospedale S. Spirito, Azienda Sanitaria Pescara
🇮🇹Pescara, Italy
AOU Policlinico Umberto I
🇮🇹Roma, Italy
IRCCS Ospedale Pediatrico Bambino Gesu
🇮🇹Roma, Italy
Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
IRCCS Materno Infantile Burlo Garofolo
🇮🇹Trieste, Italy
Tokyo Metropolitan Children's Medical Center
🇯🇵Fuchu, Japan
Kanazawa University Hospital
🇯🇵Kanazawa, Japan
Kobe University Hospital
🇯🇵Kobe, Japan
Japanese Red Cross Kumamoto Hospital
🇯🇵Kumamoto, Japan
Shinshu University Hospital
🇯🇵Matsumoto, Japan
Saga University Hospital
🇯🇵Saga, Japan
National Center for Child Health and Development
🇯🇵Setagaya Ku, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Takatsuki, Japan
Saiseikai Yokohamashi Tobu Hospital
🇯🇵Yokohama, Japan
Akershus Universitetssykehus
🇳🇴Lørenskog, Norway
Oslo University Hospital
🇳🇴Oslo, Norway
Universitetssykehuset Nord-Norge HF
🇳🇴Tromso, Norway
St. Olavs Hospital
🇳🇴Trondheim, Norway
Copernicus Podmiot Leczniczy Sp. z o.o
🇵🇱Gdansk, Poland
Korczowski Bartosz Gabinet Lekarski
🇵🇱Rzeszow, Poland
Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
🇵🇱Warszawa, Poland
Instytut Pomnik Centrum Zdrowia Dziecka
🇵🇱Warszawa, Poland
Uls Santa Maria - Hosp. Santa Maria
🇵🇹Lisboa, Portugal
Uls Santo Antonio - Cmin
🇵🇹Porto, Portugal
Uls Sao Joao - Hosp. Sao Joao
🇵🇹Porto, Portugal
Hosp. Infantil Univ. Nino Jesus
🇪🇸Madrid, Spain
Corporacio Sanitari Parc Tauli
🇪🇸Sabadell, Spain
Hosp. Univ. I Politecni La Fe
🇪🇸València, Spain
Gazi University Medical Faculty
🇹🇷Ankara, Turkey
Ankara University Medical Faculty
🇹🇷Ankara, Turkey
Istanbul University Cerrahpasa Medical Faculty
🇹🇷Istanbul, Turkey
Marmara University Pendik Training Hospital
🇹🇷Istanbul, Turkey