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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 being studied for the treatment of moderately to severely active ulcerative colitis, a form of inflammatory bowel disease affecting the colon. It is an investigational small molecule developed by Johnson & Johnson and has completed a Phase 2 clinical trial in this indication.
JNJ-54781532 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored a Phase 2 study of the drug in patients with moderately to severely active ulcerative colitis.
JNJ-54781532 has completed a Phase 2 clinical trial and is an investigational drug, not an approved therapy. The Phase 2 study evaluated its safety and effectiveness in patients with moderately to severely active ulcerative colitis.
JNJ-54781532 has been evaluated in one completed Phase 2 trial, NCT01959282, titled A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis. The randomized, double-blind, placebo-controlled study enrolled 219 patients across 14 countries.