An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Number of participants experiencing TEAEs, Serious TEAEs, TEAEs leading to discontinuation and TEAEs of special interest. TEAE is defined as any event with an onset date on or after the first dose date, or any ongoing event on the first dose date that worsens in severity on or after the first dose date, and until 90 days following the last dose of treatment with the study drug.

Time frame: From first dose to 90 days post last dose (Up to approximately 92 months)

Population: All treated participants

The 9-point Mayo Score is a composite of three assessments, each rated from 0 to 3: 1. Stool frequency: (0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal) 2. Rectal bleeding (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time; 3 = Blood alone passes) 3. Endoscopy (0 = Normal or inactive disease; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease) The total score range is from 0-9, with higher score indicating worse disease activity. Baseline is the last measurement collected on or prior to the date of first dose in the 3102 OLE study.

Time frame: Baseline, week 46, 94, 142, 190, 238, 286, 334, 382

Population: All treated participants from RPC01-3101 as pre-specified with baseline and post-baseline measurements at the specified time points

The Complete Mayo Score is a composite of four assessments, each rated from 0 to 3: 1. Stool frequency: (0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal) 2. Rectal bleeding (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time; 3 = Blood alone passes) 3. endoscopy (0 = Normal or inactive disease; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease) 4. Physician's Global Assessment (0 = Normal; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease). The total score range is from 0-12, with higher score indicating worse disease activity. Baseline is the last measurement collected on or prior to the date of first dose in the 3102 OLE study.

Time frame: Baseline, week 46, 94, 142, 190, 238, 286, 334, 382

Population: All treated participants from RPC01-3101 as pre-specified with baseline and post-baseline measurements at the specified time points

The Partial Mayo Score is a composite of three assessments, each rated from 0 to 3: 1. Stool frequency: (0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal) 2. Rectal bleeding (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time; 3 = Blood alone passes) 3. Physician's Global Assessment (0 = Normal; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease). The total score range is from 0-9, with higher score indicating worse disease activity. Baseline is the last measurement collected on or prior to the date of first dose in the 3102 OLE study.

Time frame: Baseline, week 46, 94, 142, 190, 238, 286, 334, 382

Population: All treated participants from RPC01-3101 as pre-specified with baseline and post-baseline measurements at the specified time points

Clinical Remission is defined as Rectal bleeding subscore=0; stool frequency subscore \<=1 (and a decrease of \>=1 point from the baseline stool frequency subscore); and endoscopy subscore \<=1. Rectal bleeding 0 = No blood seen Stool frequency 0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal Endoscopy 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability).

Time frame: Week 46, 94, 142, 190, 238

Population: All treated participants who had previously received anti-TNF therapy and who are evaluated for clinical remission at the specified visit point

Clinical response is defined as reduction from baseline in the 9-point Mayo score of \>=2 points and reduction from baseline in the 9-point Mayo score \>=35%, and (reduction from baseline in the rectal bleeding subscore of \>=1 point or a rectal bleeding subscore of \<=1 point). 9 point Mayo score is defined as the sum of rectal bleeding subscore, stool frequency subscore, and the endoscopy subscore each ranging from (0=normal activity-3=worse activity) for a total score that ranges from 0 to 9 with higher score indicating worsening symptoms.

Time frame: Week 46, 94, 142, 190, 238

Population: All treated participants who had Previously Received anti-TNF Therapy and who are evaluated for clinical response at the specified visit point

Endoscopic Improvement is defined as endoscopy subscore of \<=1 point. 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability)

Time frame: Week 46, 94, 142, 190, 238

Population: All treated participants who had Previously Received anti-TNF Therapy and who are evaluated for endoscopic improvement at the specified visit point

Clinical Remission is defined as Rectal bleeding subscore=0; stool frequency subscore \<=1 (and a decrease of \>=1 point from the baseline stool frequency subscore); and endoscopy subscore \<=1. Rectal bleeding 0 = No blood seen Stool frequency 0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal Endoscopy 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability).

Time frame: Week 46, 94, 142, 190, 238

Population: All treated participants who are evaluated for clinical remission at the specified visit point

Clinical response is defined as reduction from baseline in the 9-point Mayo score of \>=2 points and reduction from baseline in the 9-point Mayo score \>=35%, and (reduction from baseline in the rectal bleeding subscore of \>=1 point or a rectal bleeding subscore of \<=1 point). 9 point Mayo score is defined as the sum of rectal bleeding subscore, stool frequency subscore, and the endoscopy subscore each ranging from (0=normal activity-3=worse activity) for a total score that ranges from 0 to 9 with higher score indicating worsening symptoms.

Time frame: Week 46, 94, 142, 190, 238

Population: All treated participants who are evaluated for clinical response at the specified visit point

Corticosteroid-free remission is defined as clinical remission while off corticosteroids for ≥12 weeks. Clinical Remission is defined as Rectal bleeding subscore=0; stool frequency subscore \<=1 (and a decrease of \>=1 point from the baseline stool frequency subscore); and endoscopy subscore \<=1. Rectal bleeding 0 = No blood seen Stool frequency 0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal Endoscopy 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability).

Time frame: Week 46, 94, 142, 190, 238

Population: All treated participants who are evaluated for corticosteroid-free remission at the specified visit point

Endoscopic Improvement is defined as endoscopy subscore of \<=1 point. 0 = Normal or inactive disease; 1. = Mild disease (erythema, decreased vascular pattern, does not include friability) 2. = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions) 3. = Severe disease (spontaneous bleeding, ulceration)

Time frame: Week 46, 94, 142, 190, 238

Population: All treated participants who are evaluated for endoscopic improvement at the specified visit point

Histologic remission is defined as Geboes index score \< 2.0. The Geboes score is a validated histological grading system for UC that ranges from 0=no disease activity to 5=high disease activity.

Time frame: Week 46, 94, 142, 190, 238

Population: All treated participants who are evaluated for histologic remission at the specified visit point

Mucosal Healing is defined as Endoscopy subscore of ≤ 1 point (0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability)) and a Geboes index score \< 2.0 (The Geboes score is a validated histological grading system for UC that ranges from 0=no disease activity to 5=high disease activity.)

Time frame: Week 46, 94, 142, 190, 238

Population: All treated participants who are evaluated for mucosal healing at the specified visit point