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SPD476 · 3 trials · 3 indications
Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (\>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.
Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal \[intact vascular pattern; no friability or granulation\], 1 = mild \[erythema; decreased vascular pattern; minimal granularity\], 2 = moderate \[marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations\], 3 = severe \[ulceration; spontaneous bleeding\].
| Arm | Type | Description |
|---|---|---|
| SPD476 (1.2 g) | EXPERIMENTAL | - |
| SPD476 (2.4 g) | EXPERIMENTAL | - |
| SPD476 (4.8 g) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| SPD476 | EXPERIMENTAL | Mesalazine |
| Asacol | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SPD476 (1.2g) | DRUG | 1.2g SPD476 once daily (QD) orally |
| SPD476 (2.4 g) | DRUG | 2.4g SPD476 QD orally |
| SPD476 (4.8 g) | DRUG | 4.8g SPD476 QD orally |
| Placebo | DRUG | QD orally |
| SPD476 | DRUG | 2.4 g/day Once Daily (QD) |
| Asacol | DRUG | 1.6g/day administered 800 mg Twice Daily (BID) |
| SPD476 (mesalazine) | DRUG | - |
Inclusion Criteria: 1. Males and females =\>18yrs of age. 2. If female of childbearing potential (FOCP), has demonstrated a negative beta HCG (human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any applicable contraceptive requirements of the protocol. 3. An episode of ac...
SPD476 is an investigational small molecule being studied for gastrointestinal conditions, specifically ulcerative colitis and diverticulitis. It has been evaluated in Phase 3 clinical trials for maintaining remission in patients with ulcerative colitis and for the prevention of recurrence of diverticulitis.
SPD476 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company has sponsored Phase 3 clinical trials of SPD476 for ulcerative colitis and diverticulitis.
SPD476 is in Phase 3 clinical development. It has completed Phase 3 trials for ulcerative colitis and diverticulitis, but it remains investigational and is not approved for any use.
SPD476 has been studied in three completed Phase 3 trials: NCT00151892 and NCT00151944 for maintaining remission in ulcerative colitis, and NCT00545740 for prevention of recurrence of diverticulitis. These trials enrolled a total of over 1,800 patients.
SPD476 is the primary name used in clinical trials. No alternative names have been reported for this investigational drug in the available data.