A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis

NCT07196748
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
882
clinicaltrials.gov
Lead sponsor
Janssen Research & Development, LLC
clinicaltrials.gov
Start date
2025-10-01
clinicaltrials.gov
Number of sites
402
clinicaltrials.gov

Summary
The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).
clinicaltrials.gov
Acronym
ICONIC-UC
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Short title
A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
clinicaltrials.gov
Official title
A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults With an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2032-01-13
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First posted
2025-09-29
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Registry last updated
2026-09-25
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Primary completion date
2028-01-14
clinicaltrials.gov
Start date
2025-10-01
clinicaltrials.gov

Participants
882
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Participant count basis
Estimated
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Planned participants
882
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Protocol amendments
2
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Number of sites
402
clinicaltrials.gov

Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Janssen Research & Development, LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07196748
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07196748
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masking description
This study is double-blind for adults and open-label for adolescent participants.
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12

    Timeframe: At Week I-12

    Percentage of adult participants in clinical remission at Week I-12 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

  2. DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40

    Timeframe: At Week M-40

    Percentage of adult participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

  3. Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40

    Timeframe: At Week M-40

    Percentage of adolescent participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

  1. DB Induction Study: Percentage of Adult Participants in Clinical Response at Week I-12

    Timeframe: At Week I-12

    Percentage of adult participants in clinical response at Week I-12 will be reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.

  2. DB Induction Study: Percentage of Adult Participants with Endoscopic Improvement at Week I-12

    Timeframe: At Week I-12

    Percentage of adult participants with endoscopic improvement at Week I-12 will be reported. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.

  3. DB Induction Study: Percentage of Adult Participants in Symptomatic Remission at Week I-12

    Timeframe: At Week I-12

    Percentage of adult participants in symptomatic remission at Week I-12 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.

  4. DB Induction Study: Percentage of Adult Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12

    Timeframe: At Week I-12

    Percentage of adult participants with IBDQ remission at Week I-12 will be reported. IBDQ remission is defined as an IBDQ total score of \>= 170. The IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific health related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

  5. DB Induction Study: Percentage of Adult Participants with Histologic-Endoscopic Mucosal Improvement (HEMI) at Week I-12

    Timeframe: At Week I-12

    Percentage of adult participants with HEMI at Week I-12 will be reported. HEMI is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in less than (\<) 5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy sub-score of 0 or 1.

  6. DB Induction Study: Percentage of Adult Participants with Fatigue Response at Week I-12

    Timeframe: At Week I-12

    Percentage of adult participants with fatigue response at Week I-12 will be reported. Fatigue response is defined as a \>= 7-point reduction in the patient-reported outcomes measurement information system (PROMIS)-fatigue Short Form (SF)-7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise).

  7. DB Induction Study: Percentage of Adult Participants in Symptomatic Remission at Week I-4

    Timeframe: At Week I-4

    Percentage of adult participants in symptomatic remission at Week I-4 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.

  8. DB Induction Study: Percentage of Adult Participants in Endoscopic Remission at Week I-12

    Timeframe: At Week I-12

    Percentage of adult participants in endoscopic remission at Week I-12 will be reported. Endoscopic remission is defined as an endoscopy subscore of 0.

  9. DB Induction Study: Percentage of Adult Participants with No Bowel Urgency at Week I-12

    Timeframe: At Week I-12

    Percentage of adult participants with no bowel urgency at Week I-12 will be reported using the ulcerative colitis patient-reported outcomes signs and symptoms (UC-PRO/SS). The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of gastrointestinal (GI) signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.

  10. DB Induction Study: Percentage of Adult Participants with No Abdominal Pain at Week I-12

    Timeframe: At Week I-12

    Percentage of adult participants with no abdominal pain at Week I-12 will be reported using the UC-PRO/SS. The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of GI signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.

  11. DB Induction Study: Percentage of Adult Participants with No Bowel Incontinence at Week I-12

    Timeframe: At Week I-12

    Percentage of adult participants with no bowel incontinence at Week I-12 will be reported using the UC-PRO/SS. The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of GI signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.

  12. DB Induction Study: Percentage of Adult Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Timeframe: Up to Week I-12

    Percentage of adult participants with AEs and SAEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important.

  13. DB Maintenance Study: Percentage of Adult Participants with Endoscopic Improvement at Week M-40

    Timeframe: At Week M-40

    Percentage of adult participants with endoscopic improvement at Week M-40 will be reported. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.

  14. DB Maintenance Study: Percentage of Adult Participants in Symptomatic Remission at Week M-40

    Timeframe: At Week M-40

    Percentage of adult participants in symptomatic remission at Week M-40 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.

  15. DB Maintenance Study: Percentage of Adult Participants with 90-day Corticosteroid-free Clinical Remission at Week M-40

    Timeframe: At Week M-40

    Percentage of adult participants with 90-day corticosteroid-free clinical remission at Week M-40 will be reported. 90-day corticosteroid-free clinical remission is defined as the clinical remission at the visit and not receiving corticosteroids for 90 days prior to the visit.

  16. DB Maintenance Study: Percentage of Adult Participants with HEMI at Week M-40

    Timeframe: At Week M-40

    Percentage of adult participants with HEMI at Week M-40 will be reported. HEMI is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in \< 5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy sub-score of 0 or 1.

  17. DB Maintenance Study: Percentage of Adult Participants with IBDQ Remission at Week M-40

    Timeframe: At Week M-40

    Percentage of adult participants with IBDQ remission at Week M-40 will be reported. IBDQ remission is defined as an IBDQ total score of \>= 170. The IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific HRQoL across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

  18. DB Maintenance Study: Percentage of Adult Participants in Endoscopic Remission at Week M-40

    Timeframe: At Week M-40

    Percentage of adult participants in endoscopic remission at Week M-40 will be reported. Endoscopic remission is defined as an endoscopy subscore of 0.

  19. DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40 Among the Participants who had Achieved Clinical Remission at Maintenance Baseline

    Timeframe: At Week M-40

    Percentage of adult participants in clinical remission at Week M-40 among the participants who had achieved clinical remission at maintenance baseline will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

  20. DB Maintenance Study: Percentage of Adult Participants in Histologic-Endoscopic Mucosal Remission at Week M-40

    Timeframe: At Week M-40

    Percentage of adult participants in histologic-endoscopic mucosal remission at Week M-40 will be reported. Histologic-endoscopic mucosal remission is defined as achieving a combination of histologic remission and endoscopic remission. Histologic remission is defined as the absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system. Endoscopic remission is defined as an endoscopy subscore of 0.

  21. DB Maintenance Study: Percentage of Adult Participants with Fatigue Response at Week M-40

    Timeframe: At Week M-40

    Percentage of adult participants with fatigue response at Week M-40 will be reported. Fatigue response is defined as a \>= 7-point reduction in the PROMIS-fatigue SF-7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise).

  22. DB Maintenance Study: Percentage of Adult Participants with Disease Clearance at Week M-40

    Timeframe: At Week M-40

    Percentage of adult participants with disease clearance at Week M-40 will be reported. Disease clearance is defined as a composite of symptomatic remission and histologic-endoscopic mucosal remission. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. Histologic-endoscopic mucosal remission is defined as achieving a combination of histologic remission and endoscopic remission.

  23. DB Maintenance Study: Percentage of Adult Participants with No Bowel Urgency at Week M-40

    Timeframe: At Week M-40

    Percentage of adult participants with no bowel urgency at Week M-40 will be reported using the UC-PRO/SS. The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of GI signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.

  24. DB Maintenance Study: Percentage of Adult Participants with No Abdominal Pain at Week M-40

    Timeframe: At Week M-40

    Percentage of adult participants with no abdominal pain at Week M-40 will be reported using the UC-PRO/SS. The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of GI signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.

  25. DB Maintenance Study: Percentage of Adult Participants with No Bowel Incontinence at Week M-40

    Timeframe: At Week M-40

    Percentage of adult participants with no bowel incontinence at Week M-40 will be reported using the UC-PRO/SS. The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of GI signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.

And 19 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Minimum age
12 Years
Healthy volunteers
No

  • Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC
  • Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy
  • An endoscopy subscore greater than or equal to (>=) 2 as obtained during central review of the screening video endoscopy
  • Adolescent Participants: body weight must be >= 40 kilograms (kg) at baseline (Week I-0)
  • Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [β-hCG]) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests
  • Demonstrated an inadequate response to, or failure to tolerate conventional therapy but are naïve to advanced therapies (ADT naïve), or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of UC (ADT-inadequate responder [IR]) as defined in the protocol

  • Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study
  • Presence of a stoma
  • Presence or history of a fistula
  • Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline
  • History of extensive colonic resection (that is, less than [<] 30 centimeter [cm] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention
Sources for eligibility
clinicaltrials.gov

  • AZ Gastro CareChandler, United StatesRecruiting
  • Research Solutions of ArizonaLitchfield Park, United StatesRecruiting
  • Mayo ClinicScottsdale, United StatesRecruiting
  • Clinnova ResearchAnaheim, United StatesRecruiting
  • Southern California Research CenterCoronado, United StatesRecruiting
  • Om Research LLCLancaster, United StatesRecruiting
  • TLC Clinical Research IncLos Angeles, United StatesRecruiting
  • GastroIntestinal BioscienceLos Angeles, United StatesRecruiting
  • Hoag Memorial HospitalNewport Beach, United StatesRecruiting
  • Om Research LLC 2Oxnard, United StatesRecruiting
  • Stanford Medicine Children's HealthPalo Alto, United StatesRecruiting
  • Clinical Applications Laboratories, IncSan Diego, United StatesCompleted
  • Medical Associates Research Group, Inc.San Diego, United StatesRecruiting
  • University of California San FranciscoSan Francisco, United StatesRecruiting
  • Peak Gastroenterology AssociatesColorado Springs, United StatesRecruiting
  • Nuvance Health Danbury HospitalDanbury, United StatesCompleted
  • Connecticut Children's Medical CenterHartford, United StatesRecruiting
  • American Institute of ResearchCutler Bay, United StatesRecruiting
  • Nature Coast Clinical ResearchInverness, United StatesRecruiting
  • Florida Research InstituteLakewood Rch, United StatesRecruiting
  • GCP Clinical ResearchTampa, United StatesRecruiting
  • Atlanta Gastroenterology AssociatesAtlanta, United StatesRecruiting
  • Children's Center for Digestive Health CareAtlanta, United StatesRecruiting
  • Gastroenterolgy Associates of Central GAMacon, United StatesRecruiting
  • IU Health University HospitalIndianapolis, United StatesRecruiting

And 377 more, listed on the interactive page.

Sources for sites
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  • 2025
  • 2025-521381-10-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (2)