Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-54781532 once daily · 1 trial · 1 indication
The Mayo score is the primary tool for assessing ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, findings of endoscopy, and physician's global assessment) which range from 0 to 3. The Mayo score is calculated as the sum of these 4 subscores and can range between 0 and 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo once daily from Week 0 to Week 8. Participants in clinical response at Week 8 will continue to receive placebo through Week 32. Participants not in clinical response at Week 8 will receive treatment with 150 mg JNJ-54781532 orally once daily from Week 8 to Week 16. Participants who achieve a partial Mayo score response (ie, a change from baseline of ≥3 in the partial Mayo score) at Week 16 can continue receiving 150 mg JNJ-54781532 orally once daily through Week 32 |
| JNJ-54781532 25 mg once daily | EXPERIMENTAL | Participants will receive 25 mg of JNJ-54781532 once daily from Week 0 to Week 8. Participants in clinical response at Week 8 will continue to receive the same dosage through Week 32 and participants not in clinical response at Week 8 will continue to receive the same dosage through Week 16. At Week 16, participants who do not achieve a partial Mayo score response (ie, a change from baseline of ≥3 in the partial Mayo score) will be discontinued from study medication, and participants who achieve a partial Mayo score response at Week 16 can continue receiving JNJ 54781532 25 mg once daily through Week 32 |
| JNJ-54781532 75 mg once daily | EXPERIMENTAL | Participants will receive 75 mg of JNJ-54781532 once daily from Week 0 to Week 8. Participants in clinical response at Week 8 will continue to receive the same dosage through Week 32 and participants not in clinical response at Week 8 will continue to receive the same dosage through Week 16. At Week 16, participants who do not achieve a partial Mayo score response (ie, a change from baseline of ≥3 in the partial Mayo score) will be discontinued from study medication, and participants who achieve a partial Mayo score response at Week 16 can continue receiving JNJ 54781532 75 mg once daily through Week 32 |
| JNJ-54781532 150 mg once daily | EXPERIMENTAL | Participants will receive 150 mg of JNJ-54781532 once daily from Week 0 to Week 8. Participants in clinical response at Week 8 will continue to receive the same dosage through Week 32 and participants not in clinical response at Week 8 will continue to receive the same dosage through Week 16. At Week 16, participants who do not achieve a partial Mayo score response (ie, a change from baseline of ≥3 in the partial Mayo score) will be discontinued from study medication, and participants who achieve a partial Mayo score response at Week 16 can continue receiving JNJ 54781532 150 mg once daily through Week 32 |
| JNJ-54781532 75 mg twice daily | EXPERIMENTAL | Participants will receive 75 mg of JNJ-54781532 twice daily from Week 0 to Week 8. Participants in clinical response at Week 8 will continue to receive the same dosage through Week 32 and participants not in clinical response at Week 8 will continue to receive the same dosage through Week 16. At Week 16, participants who do not achieve a partial Mayo score response (ie, a change from baseline of ≥3 in the partial Mayo score) will be discontinued from study medication, and participants who achieve a partial Mayo score response at Week 16 can continue receiving JNJ 54781532 75 mg twice daily through Week 32 |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Participants will receive placebo once daily |
| JNJ-54781532 25 mg once daily | DRUG | Participants will receive 25 mg of JNJ-54781532 once daily |
| JNJ-54781532 75 mg once daily | DRUG | Participants will receive 75 mg of JNJ-54781532 once daily |
| JNJ-54781532 150 mg once daily | DRUG | Participants will receive 150 mg of JNJ-54781532 once daily |
| JNJ-54781532 75 mg twice daily | DRUG | Participants will receive 75 mg of JNJ-54781532 twice daily |
Inclusion Criteria: * Have a clinical diagnosis of ulcerative colitis (UC) at least 3 months prior to screening * Have moderately to severely active UC, defined as a baseline (Week 0) Mayo score of 6 to 12; including an endoscopy sub score greater than or equal to 2 as determined by a central read ...
JNJ-54781532 is an investigational small molecule being studied for the treatment of moderately to severely active ulcerative colitis, a form of inflammatory bowel disease. It is administered once daily and is currently in Phase 2 clinical development.
JNJ-54781532 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in patients with ulcerative colitis.
JNJ-54781532 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to determine its safety and efficacy for treating ulcerative colitis.
JNJ-54781532 has one completed Phase 2 clinical trial, identified as NCT01959282. This randomized, double-blind, placebo-controlled study enrolled 219 patients with moderately to severely active ulcerative colitis and was conducted across multiple countries including the United States, Australia, and several European nations.
No alternative names for JNJ-54781532 have been disclosed. The drug is identified solely by its development code, JNJ-54781532, and is being studied as a once-daily oral treatment for ulcerative colitis.