Clinical remission (based on the Mayo scoring system) is defined as: a rectal bleeding sub-score = 0, and an endoscopy sub-score ≤1 (excluding friability), and at least 1-point decrease in stool frequency sub-score from baseline to achieve a stool frequency sub-score ≤1

Proportion of patients with clinical response at week 48 Clinical response is defined as: a reduction in Mayo Score ≥ 3 points and ≥ 30 % from baseline with an accompanying decrease in rectal bleeding sub-score ≥ 1 point or absolute rectal bleeding sub-score ≤ 1 point.

Proportion of patients with endoscopic improvement at week 48 among all patients.

Proportion of patients with endoscopic improvement at week 96 among all patients.

Endoscopic improvement is defined as a Mayo endoscopic sub score of ≤1 (excluding friability).

Proportion of patients with endoscopic remission at week 48 among all patients. Proportion of patients with endoscopic remission at week 96 among all patients. Endoscopic remission is defined as a Mayo endoscopic sub score of 0.

Proportion of patients with sustained endoscopic changes at week 48 and 96. Sustained endoscopic changes is defined as the number of patients with endoscopic changes at week 48 among patients who had endoscopic changes during the Induction study (at week 8 or week 16 of study ABX464-103).

At Week 8 of the induction study, endoscopic improvement was achieved by 70 patients; 16 patients achieved endoscopic remission

Change in Modified Mayo Score (MMS) at weeks 48 and 96 and in partial Modified Mayo Score (pMMS)

MMS is a composite score of UC disease activity calculated as the sum of the following 3 subscores:

1. Stool frequency, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
2. Rectal bleeding, scored from 0 (no blood seen) to 3 (blood alone passed).
3. Endoscopic evaluation, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).

The overall MMS ranges from 0 to 9 where higher scores represent more severe disease.

pMMS is a composite score of UC disease activity calculed as the sum of the following 2 subscores:

1. Stool frequency, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
2. Rectal bleeding, scored from 0 (no blood seen) to 3 (blood alone passed). The overall pMMS ranges from 0 to 6 where higher scores represent more severe disease.

Number of patients in the Full analysis set is 217; number analyzed in different rows correspond to number of patients analysed in the relevant week (lower than the overall number analyzed in FAS)

Participants recorded stool frequency using a paper subject diary on a daily basis. The stool frequency subscore ranges from 0 to 3 according to the following scale:

Score 0: Normal number of stools Score 1: 1 to 2 stools per day more than normal Score 2: 3 to 4 stools per day more than normal Score 3: 5 or more stools per day more than normal

Number of patients in the Full analysis set is 217; number analyzed in different rows correspond to number of patients analysed in the relevant week (lower than the overall number analyzed in FAS)

Participants recorded rectal bleeding in a paper subject diary on a daily basis. Rectal bleeding score is taken as the worst subscore of the three most recent scores within 7 days prior to the visit.

The rectal bleeding subscore ranges from 0 to 3 according to the following scale:

Score 0: No blood seen Score 1: Streaks of blood with stool less than half the time Score 2: Obvious blood with stool most of the time Score 3: Blood alone passed A lower score represents an improvement in rectal bleeding.

Number of patients in the Full analysis set is 217; number analyzed in different rows correspond to number of patients analysed in the relevant week (lower than the overall number analyzed in FAS)

Change to baseline in C-Reactive Protein levels

Number of patients in the Full analysis set is 217; number analyzed in different rows correspond to number of patients analysed in the relevant week

Change relative to baseline in miRNA-124 expression in rectal/sigmoidal biopsies at week 48 and in total blood at week 24 and week 48.

Absolute quantification (QuantaSoft Pro) of the miR-124 copy number was performed at baseline of the induction study, at week 48 and at week 96 by using droplet digital PCR technology on 115 whole blood samples and 240 rectal biopsy samples.

Number and rate of all adverse events, causally-related adverse events, all serious adverse events and causally-related serious adverse events classified by severity.

Incidence of treatment-emergent serious adverse events, hospitalizations, total inpatient days.

Incidence of adverse events leading to investigational product discontinuation. Number of clinically significant laboratory abnormalities.

the safety analysis set (SAF) included all patients who had at least one dose of investigational product