Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG00012 Dose 1 · 3 trials · 1 indication
Participant-reported flushing side effect events during the treatment period recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Participant-reported flushing events during the overall treatment period, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.
Participant-reported flushing events during Weeks 1 to 4 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.
Participant-reported flushing events during Weeks 5 to 8 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.
The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.
The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.
The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.
Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.
Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.
The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.
The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.
The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.
| Arm | Type | Description |
|---|---|---|
| BG00012 | EXPERIMENTAL | Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks. |
| BG00012 + ASA | EXPERIMENTAL | Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks. |
| BG00012 Slow Titration | EXPERIMENTAL | Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks. |
| Chinese Subjects - Dose 1 BG00012 | EXPERIMENTAL | - |
| Chinese Subjects - Dose 2 BG00012 | EXPERIMENTAL | - |
| Japanese Subjects - Dose 1 BG00012 | EXPERIMENTAL | - |
| Japanese Subjects - Dose 2 BG00012 | EXPERIMENTAL | - |
| Caucasian Subjects - Dose 1 BG00012 | EXPERIMENTAL | - |
| Caucasian Subjects - Dose 2 BG00012 | EXPERIMENTAL | - |
| BG00012 API | ACTIVE_COMPARATOR | BG00012 API |
| Name | Type | Description |
|---|---|---|
| BG00012 (dimethyl fumarate) | DRUG | Each capsule contains 120 mg dimethyl fumarate (DMF). Fast titration involves taking one 120 mg capsule in the morning and one in the evening (240 mg daily) for one week, and then escalating to a dose of 480 mg daily (two capsules morning and evening) for the remainder of the study.Slow titration expands the dose escalation time to 4 weeks. |
| BG00012 placebo | DRUG | Placebo matching BG00012 |
| ASA | DRUG | 325 mg microcoated aspirin (ASA) |
| ASA placebo | DRUG | Placebo matching aspirin |
| BG00012 Dose 1 | DRUG | - |
| BG00012 Dose 2 | DRUG | - |
| BG00012 | DRUG | Sequence 1: Oral 240 mg BG00012 Standard Formulation \& Following 7 day washout period, 240 mg BG00012 API. Sequence 2: 240 mg BG00012 API \& Following 7 day washout period, 240 mg BG00012 Standard Formulation. |
Key Inclusion Criteria: * Must give written informed consent and any authorizations required by local law * Must have a body mass index (BMI) of between 18.0 to 34.0 kg/m\^2,inclusive. * Ability to complete the tolerability scales by accurately using the hand-held subject reporting device * Subject...
BG00012 is an investigational small molecule being studied for the treatment of relapsing-remitting multiple sclerosis and active rheumatoid arthritis. It is developed by Biogen Inc. (NASDAQ: BIIB) and is currently in clinical development, with completed trials in both indications.
BG00012 is a small molecule developed by Biogen Inc. (NASDAQ: BIIB) for neurological and inflammatory conditions. Its specific molecular target has not been disclosed in available clinical trial information, and it is being evaluated for its efficacy and safety in relapsing-remitting multiple sclerosis and rheumatoid arthritis.
BG00012 is being developed by Biogen Inc., a biotechnology company traded on NASDAQ under the ticker BIIB. Biogen is conducting clinical trials to evaluate the drug's safety and efficacy in patients with relapsing-remitting multiple sclerosis and rheumatoid arthritis.
BG00012 has completed Phase 1, Phase 2, and Phase 3 clinical trials. The most advanced completed studies are Phase 3 trials in relapsing-remitting multiple sclerosis, and a Phase 2 trial in rheumatoid arthritis. BG00012 is investigational and not yet approved by regulatory authorities.
BG00012 has completed three clinical trials: NCT00420212, a Phase 3 study in relapsing-remitting multiple sclerosis with 1,234 participants; NCT00451451, a Phase 3 study with active reference in relapsing-remitting multiple sclerosis with 1,417 participants; and NCT00810836, a Phase 2 study with methotrexate in active rheumatoid arthritis with 153 participants.
BG00012 is an investigational drug developed by Biogen Inc. (NASDAQ: BIIB) for relapsing-remitting multiple sclerosis and rheumatoid arthritis. It has completed Phase 3 trials in multiple sclerosis and Phase 2 trials in rheumatoid arthritis, but its chemical identity and relationship to other compounds have not been disclosed in the available clinical trial data.