a study of safety and effectiveness of jnj-54781532 in patients with moderately to severely active ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the purpose of the study is to evaluate dose response of jnj-54781532 in participants with moderately to severely active ulcerative colitis (uc).

this is a phase 2b, multicenter, randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study), parallel-group (each group of participants will be treated at the same time), dose-response study (a study to evaluate response to different dosages of study medication) of oral tablets of jnj-54781532 in adult participants with moderately to severely active uc. approximately 220 participants will be randomized in a 1:1:1:1:1 ratio to 1 of 5 treatment groups at week 0 (placebo; jnj-54781532 25 mg once daily; jnj-54781532 75 mg once daily; jnj-54781532 150 mg once daily; and jnj-54781532 75 mg twice daily) to receive their randomized dosage of study medication through week 8 and will be assessed for clinical response at week 8. participants who achieve clinical response at week 8 will continue to receive their original randomized dosage of study medication through week 32. participants who do not achieve clinical response at week 8 will be treated as follows: participants originally randomized to placebo will receive jnj-54781532 150 mg once daily through week 16; participants originally randomized to jnj-54781532 will continue to receive their original randomized dosage of jnj-54781532 through week 16. participants who were not in clinical response at week 8 and do not achieve a partial mayo score response (a decrease from baseline in the partial mayo score by ≥3 points) at week 16 will be discontinued from study medication; and those who achieve a partial mayo score response at week 16 can continue receiving jnj 54781532 through week 32. participants will be evaluated for safety (adverse events) up to week 36 (ie, 4 weeks after the last dose of study medication). the maximum study duration for each participant will be approximately 44 weeks (including maximum screening period).

Eligibility criteria:
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 of the video endoscopy * current treatment with oral corticosteroids or have a history of failure to respond to, or tolerate, at least 1 of the following therapies oral corticosteroids (including budesonide), 6-mercaptopurine (6-mp), azathioprine (aza), or anti- tumor necrosis factor therapy or be corticosteroid dependent (ie, an inability to successfully taper corticosteroids without a return of the symptoms of uc) * must discontinue 6-mp/aza for at least 1 week before the first dose of study medication exclusion criteria: * at imminent risk for colectomy * have ulcerative colitis limited to the rectum only or to less than 20 centimeter of the colon * presence of a stoma * presence or history of a fistula * history or current diagnosis of active or latent tuberculosis; human immunodeficiency virus; hepatitis c virus or hepatitis b virus infection; have had more than 1 herpes zoster infection or have had any diagnosis of disseminated herpes zoster * previous treatment with a janus kinase inhibitor (eg, tofacitinib)

Keywords: colitis, ulcerative jnj-54781532 moderate severe active