A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative Clinical Trial

— QUASAR Jr  

Official title:

A Phase 3 Randomized, Open-label Induction, Double-blind Maintenance, Parallel-group, Multicenter Protocol to Evaluate the Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06260163
• Other study ID #: CR109251
• Secondary ID: 2022-001285-35CN
• Status: Recruiting
• Phase: Phase 3
• Start date: January 19, 2024
• Est. completion date: August 14, 2028

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 14, 2028
• Est. primary completion date: May 22, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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, and a baseline Mayo rectal bleeding subscore >=1

• Medically stable on the basis of 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• Guselkumab Subcutaneous
Guselkumab will be administered subcutaneously.
• Matching Placebo
Week 12 induction responders will be administered placebo (matching guselkumab up to Week 56) SC at protocol specified time points to maintain the blind.
• Guselkumab Intravenous
Guselkumab will be administered intravenously.

Locations

Country	Name	City	State
Australia	Perth Children's Hospital	Nedlands
Belgium	UZ Gent	Gent
Belgium	UZ Brussel	Jette
Belgium	UZ Leuven	Leuven
China	Capital Institute of Pediatrics	Beijing
China	Peking University Third Hospital	Beijing
China	Changzhou No 2 Peoples Hospital	Changzhou City
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou
China	The Childrens 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
Denmark	Aarhus Universitetshospital	Aarhus N
Denmark	Hvidovre Hospital	Hvidovre
France	Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant	Bron cedex
France	Hopital Francois Mitterand	Dijon
France	CHRU Lille	Lille Cedex
France	APHP Hopital Robert Debre	Paris
Italy	AOU Meyer	Firenze
Italy	AOU Policlinico Umberto I	Roma
Italy	Casa Sollievo della Sofferenza	San Giovanni Rotondo
Italy	IRCCS Materno Infantile Burlo Garofolo	Trieste
Japan	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	Tokyo Medical University Hospital	Shinjuku
Japan	Osaka Medical and Pharmaceutical University Hospital	Takatsuki
Japan	Saiseikai Yokohamashi Tobu Hospital	Yokohama
Poland	Korczowski Bartosz Gabinet Lekarski	Rzeszow
Poland	Instytut Pomnik Centrum Zdrowia Dziecka	Warszawa
Poland	Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus	Warszawa
Portugal	Chp - Centro Materno Infantil Do Norte	Porto
Portugal	Chsj - Hosp. Sao Joao	Porto
Spain	Hosp. Infantil Univ. Nino Jesus	Madrid
Spain	Corporacio Sanitari Parc Tauli	Sabadell
Spain	Hosp. Univ. I Politecni La Fe	València
Turkey	Ankara University Medical Faculty	Ankara
Turkey	Gazi University Medical Faculty	Ankara
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	NYU Langone Long Island Clinical Research Associates	Lake Success	New York

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  China,  Denmark,  France,  Italy,  Japan,  Poland,  Portugal,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Clinical Remission at 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.	Week 56
Secondary	Percentage of Participants with Clinical Remission at 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.	Week 12
Secondary	Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at 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.	Week 12
Secondary	Percentage of Participants with Symptomatic Remission at 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.	Week 12
Secondary	United States: Percentage of Participants with Endoscopic Improvement at 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.	Week 12
Secondary	European Union: Percentage of Participants with Endoscopic Healing at 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.	Week 12
Secondary	Percentage of Participants with Clinical Response at 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.	Week 12
Secondary	Percentage of Participants with Symptomatic Remission at 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.	Week 56
Secondary	United States: Percentage of Participants With Endoscopic Improvement at 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.	Week 56
Secondary	European Union: Percentage of Participants With Endoscopic Healing at 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.	Week 56
Secondary	Percentage of Participants with Corticosteroid-free Clinical Remission at 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	Week 56
Secondary	Percentage of Participants with Clinical Response at 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.	Week 56
Secondary	Percentage of Participants Histo-endoscopic Mucosal Improvement at 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).	Week 56
Secondary	Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12	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.	Week 56
Secondary	Percentage of Participants Who Achieve Endoscopic Normalization at Week 56	Percentage of participants who achieve endoscopic normalization with an endoscopy subscore of 0 at Week 56 will be reported.	Week 56
Secondary	Percentage of Participants With PUCAI Remission at 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.	Week 56
Secondary	Serum Concentration of Guselkumab During Induction Phase	Serum samples will be analyzed to determine concentrations of guselkumab overtime.	From Week 0 to Week 12
Secondary	Serum Concentration of Guselkumab During Maintenance Phase	Serum samples will be analyzed to determine concentrations of guselkumab over time.	From Week 12 to Week 56
Secondary	Number of Participants with Incidence of Anti-guselkumab Antibodies	Number of participants with anti-guselkumab antibodies for all study treatment regimens will be assessed.	Up to Week 68
Secondary	Percentage of Participants with Adverse Events (AEs)	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.	Up to Week 68
Secondary	Percentage of Participants with Serious Adverse Events (SAEs)	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.	Up to Week 68
Secondary	Percentage of Participants with AEs Leading to Discontinuation of Study Intervention	Percentage of participants with AEs leading to discontinuation of study intervention will be reported.	Up to Week 68