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Also known as Acazicolcept
ALPN-101 · 1 trial · 1 indication
The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from the SLE Disease Activity Index 2000 (SLEDAI-2K), the British Isles Lupus Assessment Group (BILAG) 2004 Index, and the Physician's Global Assessment (PGA). Participants classified as responder if they met all of the following criteria: 1) ≥ 4-point reduction in the SLEDAI-2K total score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B) compared with baseline; and 3) No worsening from baseline in participants' lupus disease activity (i.e., increase of ≥0.3 0 on a 3-point scale) in PGA. The SLEDAI-2K total score falls between 0 and 105, with higher scores representing increased disease activity. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity (range: A\[severe\] to E\[no disease\]). PGA: assesses worsening in participant's general health.
The BICLA is a responder index developed to measure response to therapy, and it includes scores from the BILAG, SLEDAI-2K, and Physician's Global Assessment (PGA). BICLA response is defined as: 1) at least 1 gradation of improvement in baseline BILAG 2004 scores in all body systems with moderate disease activity at entry (eg, all B \[mild disease\] scores falling to C \[Stable and mild\], or D \[no activity\]); 2) no new BILAG A or more than 1 new BILAG B scores; 3) no worsening of total SLEDAI-2K score from baseline; 4) ≤ 10% deterioration in PGA score. The PGA is measured on a 0 to 100 mm scale with score 0 indicates No Disease Activity and score 100 indicates the most Severe Disease Activity.
| Arm | Type | Description |
|---|---|---|
| ALPN-101 (Acazicolcept) | EXPERIMENTAL | Participants received a weight-based dose of 3 milligrams/kilogram (mg/kg) ALPN-101 once every 2 weeks (Q2W) up to 24 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo matched to ALPN-101 up to 24 weeks. |
| Name | Type | Description |
|---|---|---|
| ALPN-101 | DRUG | Intravenous infusion via an infusion pump. |
| Placebo | DRUG | Intravenous infusion via an infusion pump. |
Key Inclusion Criteria Summary * SLE onset ≥ 6 months prior to Screening * Positive ANA and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test * Active lupus at Screening and Baseline, as defined per-protocol and confirmed by the study's medical monitor, including a SLEDAI score at Scr...
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ALPN-101 is being developed for the treatment of systemic lupus erythematosus, an autoimmune disease. It is an investigational therapy and has not been approved for any indication. Development is currently at the Phase 2 stage, with a completed Phase 2 study in adults with systemic lupus erythematosus.
ALPN-101 is being developed by Vertex Pharmaceuticals Incorporated, which trades under the ticker VRTX. The company is the sponsor of the clinical program evaluating ALPN-101 in systemic lupus erythematosus.
ALPN-101 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The program has not advanced beyond Phase 2 based on the available development information.
ALPN-101 has been studied in the Phase 2 trial NCT04835441, titled ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus. The trial enrolled 76 participants, was randomized, double-blind, and placebo-controlled, and has been completed. It ran in the United States, France, Hungary, Poland, Puerto Rico, Spain, and Taiwan.
Yes, acazicolcept is another name for ALPN-101. The Phase 2 trial NCT04835441 is titled ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus, confirming that both names refer to the same investigational drug candidate being developed by Vertex Pharmaceuticals.
No, ALPN-101 is not approved. It is an investigational drug still in clinical development, with a completed Phase 2 trial in systemic lupus erythematosus. Approval status has not been established for any indication.