A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis

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).

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)