Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Budesonide · 3 trials · 3 indications
The primary efficacy endpoint is clinical remission at 8 weeks, defined as a Ulcerative Colitis Disease Activity Index score of \< or = 1 with a score of 0 for both rectal bleeding and stool frequency, and \> or = 1 point reduction from baseline in endoscopy score, without any sign of mucosal friability (a score of 0 for mucosal appearance). The UCDAI has 4 components. Each component is scored on scale of 0 to 3 (total maximum \[worst\] score = 12). Definitions of component scores are as follows: stool frequency: 0 = normal frequency, 1 = 1 - 2 stools per day greater than normal frequency, 2 = 3 - 4 stools per day greater than normal frequency, and 3 = \> 4 stools per day greater than normal frequency; rectal bleeding: 0 = none, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood; physician's rating of disease activity: 0 = normal, 1 = mild, 2 = moderate, 3 = severe; mucosal appearance: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding.
Remission was a combined assessment of clinical and endoscopic variables, defined as an endoscopy score of less than or equal to (\<=) 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI) at the end of 6 weeks of treatment. MMDAI was used to assess the overall disease activity for each participant. MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment (PGA) and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Stool frequency MMDAI subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Endoscopy MMDAI subscore ranged from 0-3, where 0 indicated normal or inactive disease and 3 indicated severe disease (spontaneous bleeding, ulceration).
| Arm | Type | Description |
|---|---|---|
| Budesonide | EXPERIMENTAL | Budesonide-MMX 9 mg tablet |
| Placebo | PLACEBO_COMPARATOR | Participants who were diagnosed with active mild to moderate UP or UPS will receive 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Budesonide | DRUG | One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks. |
| Placebo | DRUG | Placebo matching to budesonide will be administered as per the dose and schedule specified in the respective arm. |
Inclusion Criteria: * Male and female patients 18 to 74 years of age, who are able to understand and voluntarily provide written informed consent * Completed all Final Visit assessments for study CB-01-02/01 (NCT00679432) and are not in clinical remission * Diagnosis of ulcerative colitis of mild t...
Budesonide is a small molecule developed by Bausch Health Companies Inc. for ulcerative colitis, ulcerative proctitis, and proctosigmoiditis. It is being studied in Phase 3 clinical trials as a locally acting treatment for these gastrointestinal inflammatory conditions, including oral extended release and rectal foam formulations.
Budesonide targets NR3C1, the glucocorticoid receptor, and acts as an agonist at this receptor. By binding and activating NR3C1, budesonide produces local anti-inflammatory effects in the gastrointestinal tract, which is the basis for its investigation in ulcerative colitis and proctitis.
Bausch Health Companies Inc., which trades under the ticker BHC, is the developer of budesonide for ulcerative colitis and proctitis. The company is advancing the drug through Phase 3 clinical development for these gastrointestinal indications.
Budesonide is in Phase 3 clinical development for ulcerative colitis, ulcerative proctitis, and proctosigmoiditis. It is an investigational therapy and has not been approved by the FDA for these indications. The Phase 3 trials listed for this program have been completed.
Three Phase 3 trials have evaluated budesonide in these gastrointestinal conditions: NCT01100112 tested oral budesonide MMX 9 mg extended release tablets in ulcerative colitis in India, while NCT01008423 and NCT01008410 tested budesonide foam in ulcerative proctitis or proctosigmoiditis in the United States. All three trials are completed.
The budesonide Phase 3 program enrolled 546 participants across its trials. NCT01100112 enrolled 61 participants, NCT01008423 enrolled 281, and NCT01008410 enrolled 265. All trials enrolled adults aged 18 years and older and were conducted in India and the United States.