Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MSTT1041A · 3 trials · 3 indications
The time to recovery was defined as the time from baseline to a clinical status score of 1 or 2 on the 7-category ordinal scale (whichever occurs first); clinical status scores are defined as follows: 1. Discharged (or "ready for discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or ≤2 Litres supplemental oxygen); 2. Non-Intensive Care Unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen; 3. Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen; 4. ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen; 5. ICU, requiring intubation and mechanical ventilation; 6. ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy); 7. Death.
The Eczema Area and Severity Index (EASI) is a standardized instrument to evaluate the extent and severity of atopic dermatitis. An area score comprised of the percentage of skin affected by eczema for each of 4 body regions (head/neck, trunk, upper extremities, and lower extremities) is calculated with 0 = none, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, and 6 = 90-100%. Severity is scored for each of the 4 body regions by the summation of the intensity scores for 4 signs (redness, thickness, scratching, and lichenification), with 0 = none/absent, 1 = mild, 2 = moderate, and 3 = severe. The minimum final EASI score is 0 and the maximum score is 72.
Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that result in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days. Adjusted rates for the overall mITT population (all participants that received at least one dose of study drug) were estimated using Poisson regression and adjusted for blood eosinophil level at the first visit, the number of asthma exacerbations requiring systemic corticosteroids in the 12 months prior to study entry, the total daily ICS dose at the first visit, and geographic region, with patient time at risk used as an offset term.
| Arm | Type | Description |
|---|---|---|
| All Placebo | PLACEBO_COMPARATOR | Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia. |
| MSTT1041A | EXPERIMENTAL | Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia. |
| UTTR1147A | EXPERIMENTAL | Participants randomized to this arm received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. A second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia. |
| Treatment | EXPERIMENTAL | Participants will receive MSTT1041A |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to MSTT1041A |
| MSTT1041A 210 mg | EXPERIMENTAL | Participants will receive MSTT1041A 210 milligrams (mg), subcutaneously every 4 weeks from randomization through Week 50. |
| MSTT1041A 490 mg | EXPERIMENTAL | Participants will receive MSTT1041A 490 mg, subcutaneously every 4 weeks from randomization through Week 50. |
| MSTT1041A 70 mg | EXPERIMENTAL | Participants will receive MSTT1041A 70 mg, subcutaneously every 4 weeks from randomization through Week 50. |
| Name | Type | Description |
|---|---|---|
| MSTT1041A | DRUG | Participants received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. |
| MSTT1041A-matched Placebo | DRUG | Participants received up to 2 intravenous infusions of MSTT1041A-matched placebo. |
| UTTR1147A | DRUG | Participants received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. A second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. |
| UTTR1147A-matched Placebo | DRUG | Participants received up to 2 intravenous infusions of UTTR1147A-matched placebo. |
| Placebo | DRUG | Participants will receive SC placebo |
Inclusion Criteria: * Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan * Peripheral capillary oxygen saturation (SpO2) ≤93% (on room air or s...
MSTT1041A is an investigational drug being studied for atopic dermatitis, COVID-19 pneumonia, and asthma. It is in Phase 2 clinical development for these conditions, with completed trials in uncontrolled severe asthma, moderate to severe atopic dermatitis, and severe COVID-19 pneumonia.
MSTT1041A is a small molecule developed by Roche Holding AG. Its specific molecular target has not been disclosed in the available information. The drug is being investigated for its efficacy and safety in respiratory and inflammatory conditions.
MSTT1041A is developed by Roche Holding AG, a multinational healthcare company. Roche is conducting clinical trials to evaluate the drug's safety and efficacy in asthma, atopic dermatitis, and COVID-19 pneumonia.
MSTT1041A is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. All three clinical trials for MSTT1041A have been completed, with no active trials currently ongoing.
MSTT1041A has completed three Phase 2 trials: NCT02918019 in uncontrolled severe asthma (517 participants), NCT03747575 in moderate to severe atopic dermatitis (65 participants), and NCT04386616 in severe COVID-19 pneumonia (396 participants). All trials were randomized, double-blind, and placebo-controlled.
Yes, MSTT1041A is also known as astegolimab. In the COVID-19 pneumonia trial (NCT04386616), the drug is referred to as MSTT1041A (Astegolimab), confirming that both names refer to the same investigational drug.