Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DISC-0974 · 4 trials · 12 indications
Assessed by treatment-emergent adverse events
The blood testing will include a hematology panel, blood chemistry panel, serology/virology panel, biomarker assessments, PK assessments, and Anti-Drug Antibodies
The urine testing will include a urinalysis
Defined as the absence of packed red blood cell (PRBC) transfusions over any rolling 12-week interval during the treatment period with a minimum hemoglobin (Hgb) of 7 g/dL. Participants meeting this criterion will be considered to have a major response to treatment.
Defined as the absence of PRBC transfusions over any rolling 16-week interval during the treatment period with a minimum Hgb of 7 g/dL. Participants meeting this criterion will be considered to have a major response to treatment.
Defined as the composite of the absence of transfusions over any rolling 12-week period and a concomitant mean Hgb increase of ≥1.5 g/dL over baseline. Participants meeting this criterion will be considered to have a major response to treatment.
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | DISC-0974 60 mg (n = 14) administered subcutaneously (SC) every 28 days for 3 doses |
| Placebo | PLACEBO_COMPARATOR | Placebo (n = 7) administered SC every 28 days for 3 doses |
| Phase 1b Single Dose | EXPERIMENTAL | Single dose of DISC-0974 |
| Single Dose of Placebo | PLACEBO_COMPARATOR | Single dose of placebo |
| Phase 1b Multiple Doses | EXPERIMENTAL | Multiple doses of DISC-0974 |
| Multiple Doses of Placebo | PLACEBO_COMPARATOR | Multiple doses of placebo |
| Phase 1b: Dose Escalation | EXPERIMENTAL | In the Phase 1b (dose-escalation) portion of the study, DISC-0974 will be administered subcutaneously every 4 weeks. |
| Phase 2: Expansion | EXPERIMENTAL | In the Phase 2 (expansion) portion of the study, DISC-0974 will be administered subcutaneously every 4 weeks. |
| Healthy Volunteer: Single Ascending Dose of DISC-0974 | EXPERIMENTAL | Single Intravenous (IV) or Subcutaneous (SC) ascending dose in healthy volunteers |
| Healthy Volunteer: Single Ascending Dose of Placebo | EXPERIMENTAL | Single Intravenous (IV) or Subcutaneous (SC) ascending dose in healthy volunteers |
| Name | Type | Description |
|---|---|---|
| DISC-0974 | DRUG | DISC-0974 is administered subcutaneously. |
| Placebo | DRUG | Placebo is administered subcutaneously |
Inclusion Criteria: Participants must meet all the following criteria at screening (unless otherwise specified) to be eligible for enrollment in the study: 1. Aged ≥18 years at the time of signing informed consent. 2. Established diagnosis of IBD (CD, UC, or IBD-unclassified) based on documented f...