Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ABBV-105
Elsubrutinib · 3 trials · 2 indications
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as an adverse event with an onset date that is on or after the first dose of study drug from Study M20-186, and no more than 30 days after the last dose of study drug from Study M20-186. For more details on adverse events please see the Adverse Event section.
SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline: * ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score * No worsening of the overall condition (\< 0.3 point increase in Physician's Global Assessment \[PhGA\]) * No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.
| Arm | Type | Description |
|---|---|---|
| ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) -> ABBV-599 High Dose | EXPERIMENTAL | Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks. |
| Elsubrutinib placebo/upadacitinib 30 mg -> Elsubrutinib placebo/upadacitinib 30 mg | EXPERIMENTAL | Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks. |
| Elsubrutinib placebo/upadacitinib placebo -> ABBV-599 High Dose | EXPERIMENTAL | Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks. |
| ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg) -> ABBV-599 Low Dose | EXPERIMENTAL | Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks. |
| Elsubrutinib 60 mg/upadacitinib placebo -> Elsubrutinib 60 mg/upadacitinib placebo | EXPERIMENTAL | Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks. |
| Elsubrutinib placebo/upadacitinib placebo -> ABBV-599 Low Dose | EXPERIMENTAL | Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks. |
| Elsubrutinib placebo/upadacitinib placebo | PLACEBO_COMPARATOR | Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks |
| ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) | EXPERIMENTAL | 60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks |
| Elsubrutinib placebo/upadacitinib 30 mg | EXPERIMENTAL | Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks |
| ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg) | EXPERIMENTAL | 60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks |
| Elsubrutinib 60 mg/upadacitinib placebo | EXPERIMENTAL | 60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks |
| ELS placebo/UPA placebo | PLACEBO_COMPARATOR | Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks |
| UPA 15 mg/ELS 60 mg | EXPERIMENTAL | 15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks |
| ELS 60 mg/UPA placebo | EXPERIMENTAL | 60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks |
| ELS 20 mg/UPA placebo | EXPERIMENTAL | 20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks |
| ELS 5 mg/UPA placebo | EXPERIMENTAL | 5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks |
| UPA 15 mg/ELS placebo | EXPERIMENTAL | 15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Elsubrutinib | DRUG | Capsule; Oral |
| Placebo for Elsubrutinib | DRUG | Capsule; Oral |
| Upadacitinib | DRUG | Film-coated tablet; Oral |
| Placebo for Upadacitinib | DRUG | Film-coated tablet; Oral |
Inclusion Criteria: * Completed Study M19-130 (i.e., the randomized controlled trial of elsubrutinib, upadacitinib, and ABBV-599 \[elsubrutinib/upadacitinib\] combination or matching placebo) and will not have developed any laboratory or clinical discontinuation criteria as defined in that study. *...
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Elsubrutinib is an investigational oral small molecule being studied for autoimmune conditions, specifically rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). It has been evaluated in Phase 2 clinical trials in adults with moderately to severely active forms of these diseases, both as a single agent and in combination with upadacitinib.
Elsubrutinib targets Bruton's tyrosine kinase (BTK) and acts as an inhibitor of this enzyme. BTK is involved in signaling pathways of immune cells, and inhibiting it is intended to modulate the immune response in autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus.
Elsubrutinib is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical trials investigating elsubrutinib in rheumatoid arthritis and systemic lupus erythematosus.
Elsubrutinib is in Phase 2 clinical development. It has not been approved by the FDA for any indication and remains an investigational agent. The completed Phase 2 trials evaluated its safety and efficacy in rheumatoid arthritis and systemic lupus erythematosus.
Elsubrutinib has been studied in three completed Phase 2 trials: NCT04451772 and NCT03978520 in systemic lupus erythematosus, and NCT03682705 in rheumatoid arthritis. These trials assessed elsubrutinib alone or in combination with upadacitinib (ABBV-599) and enrolled a total of 768 participants across multiple countries.
Yes, elsubrutinib is also known as ABBV-105. The ABBV-105 designation appears in the trial title for the rheumatoid arthritis study NCT03682705. The combination of elsubrutinib and upadacitinib is referred to as ABBV-599.