Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Icotrokinra · 4 trials · 3 indications
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.
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.
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.
The ACR 20 responders are participants with an improvement of greater than or equal to (\>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).
The ACR 20 responders are participants with an improvement of greater than or equal to (\>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity \[arthritis, VAS\] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).
Clinical response is defined as a greater than or equal to (\>=) 100-point reduction from baseline in Crohn's Disease Activity Index (CDAI) score. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Clinical remission is defined as CDAI score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Endoscopic response is defined as greater than (\>) 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
Clinical remission is defined as CDAI score \< 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Endoscopic response is defined as \> 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
| Arm | Type | Description |
|---|---|---|
| Double-blind (DB) Induction Study: Icotrokinra | EXPERIMENTAL | Adult participants will be randomized to receive icotrokinra daily, orally starting at induction Week 0 (Week I-0). At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study. |
| DB Induction Study: Placebo | PLACEBO_COMPARATOR | Adult participants will be randomized to receive placebo daily, orally starting at Week I-0. At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study. |
| DB Maintenance Study: Icotrokinra | EXPERIMENTAL | Adult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive icotrokinra daily, orally starting at maintenance Week 0 (Week M-0) through Week M-40. Participants who are clinical nonresponders to icotrokinra or placebo will also enter the Maintenance study directly and receive icotrokinra daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a long-term extension (LTE). |
| DB Maintenance Study: Placebo | PLACEBO_COMPARATOR | Adult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive placebo daily, orally starting at Week M-0 through Week M-40. Participants who are clinical responders to placebo will also enter the Maintenance study directly and continue to receive placebo daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a LTE. |
| Open-label (OL) Induction Phase: Icotrokinra | EXPERIMENTAL | Adolescent participants will enter the Induction phase and receive icotrokinra daily, orally. At Week I-12 all participants will be evaluated for clinical response and will enter the Maintenance phase. |
| OL Maintenance Phase: Icotrokinra | EXPERIMENTAL | Adolescent participants who are in clinical response to icotrokinra will enter the Maintenance phase at Week M-0 and continue to receive icotrokinra daily, orally up to Week M-40. Participants who are nonresponders to icotrokinra will also enter the Maintenance phase to receive icotrokinra daily. After completion of the Maintenance phase through Week M-40, eligible participants can participate in a LTE. |
| Group I: Icotrokinra Dose 1 | EXPERIMENTAL | Participants will receive icotrokinra dose 1. Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1. |
| Group II: Icotrokinra Dose 2 | EXPERIMENTAL | Participants will receive icotrokinra dose 2. Participants who continue into a LTE will continue to receive icotrokinra dose 2. |
| Group III: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra dose 1 or dose 2. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2. |
| Group IV: Active Reference Comparator | ACTIVE_COMPARATOR | Participants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2. |
| Induction Study 1: Icotrokinra Dose 1 | EXPERIMENTAL | Participants will receive Icotrokinra dose 1 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12. |
| Induction Study 1: Icotrokinra Dose 2 | EXPERIMENTAL | Participants will receive Icotrokinra dose 2 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12. |
| Induction Study 1: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12. |
| Induction Study 2: Icotrokinra | EXPERIMENTAL | Participants will receive Icotrokinra at the dose regimen determined in Induction Study 1 up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12. |
| Induction Study 2: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo for up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12. |
| Maintenance Study: Icotrokinra Dose 1 | EXPERIMENTAL | Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 1. Participants receiving Icotrokinra Dose 1 and meeting criteria for loss of response during the Maintenance Study will be eligibile for a single blinded dose adjustment to Icotrokinra Dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in long-term extension (LTE). |
| Maintenance Study: Icotrokinra Dose 2 | EXPERIMENTAL | Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 2. Participants who were non-responders at Week 12 of the induction studies will also receive icotrokinra maintenance dose 2 but will not be randomized. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE. |
| Maintenance Study: Placebo | PLACEBO_COMPARATOR | Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 will be randomized to receive placebo. Participants receiving placebo in induction studies 1 or 2 and in response at Week 12 of the induction study will continue to receive placebo during maintenance on non-randomized basis. Placebo non-responders from induction study will receive icotrokinra maintenance dose 2 on a non-randomized basis and will be assessed for response at Week 12. Participants receiving placebo and meeting criteria for loss of response during the Maintenance Study will be eligible for a single blinded dose adjustment to icotrokinra dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE. |
| Name | Type | Description |
|---|---|---|
| Icotrokinra | DRUG | Icotrokinra tablet will be administered orally. |
| Placebo | DRUG | Placebo tablet will be administered orally. |
| Active reference comparator | DRUG | Active reference drug will be administered. |
Inclusion Criteria: * 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...
Icotrokinra is an investigational oral small molecule being developed for immune-mediated inflammatory conditions. It is in clinical trials for psoriatic arthritis, Crohn's disease, and ulcerative colitis. It is not approved by the FDA and remains in clinical development.
Icotrokinra is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is also known by the code name JNJ-77242113.
Icotrokinra is in Phase 3 clinical trials for psoriatic arthritis and ulcerative colitis, and in Phase 2 for Crohn's disease. All studies are ongoing, with no completed trials reported. The drug is investigational and not yet approved.
Icotrokinra has four active trials. NCT06807424 and NCT06878404 are Phase 3 studies in psoriatic arthritis. NCT07196722 is a Phase 2 study in Crohn's disease. NCT07196748 is a Phase 3 study in ulcerative colitis. All are randomized, double-blind, placebo-controlled trials.
Yes, Icotrokinra is also known as JNJ-77242113. Both names refer to the same investigational drug being developed by Johnson & Johnson for inflammatory conditions.