A Phase 2a Study to Evaluate the Safety and Efficacy of Tegoprubart (AT-1501) in Patients With IgA Nephropathy (IgAN)
Bibliographic record
Abstract
Background: IgAN is the most common autoimmune nephropathy, with a young age of onset and a slow progressive course. ˜40% of affected patients progress to kidney failure within 20 years of diagnosis. Therapeutic options that delay progression are limited, and more options are needed. Tegoprubart is a next generation monoclonal antibody directed against CD40 ligand (CD40L; CD154), a target important in both cell and antibody mediated immunity. Inhibiting CD40L is expected to disrupt the pathophysiology of IgAN both upstream, by blocking antibody and immune complex formation, and downstream, by interfering with the cell based inflammatory response in the glomeruli. A Phase 2a dose-finding, open-label study, AT-1501-N205, to evaluate the safety and efficacy of tegoprubart in patients with IgAN is underway. Methods: 42 adults with biopsy proven IgAN and proteinuria ≥0.75g/24h will be enrolled into 2 sequential open-label cohorts assessing the efficacy of 10mg/kg and 5mg/kg of tegoprubart administered IV every 3 weeks. The cohorts are staggered such that the 5mg/kg cohort will not proceed if futility is seen with the 10mg/kg cohort. The cohorts have the same inc/exc criteria, visit schedule and endpoints. The primary endpoint is change from baseline of urine protein to creatinine ratio after 24 weeks of therapy. The study will continue through Week 96 to assess change in eGFR. Results: The study design includes interim analyses for futility after 12 subjects in each cohort complete 24 weeks. Futility in the 10mg/kg cohort would end the trial. Futility in the 5mg/kg cohort, would result in termination of that cohort only. Results will be presented for each cohort’s interim analysis, when each cohort completes weeks 24 and 96. Conclusions: Inhibition of CD40L has potential as a treatment for IgAN. This Phase 2 trial will assess 2 doses of tegoprubart in patients with IgAN, evaluating the drug’s ability to reduce proteinuria and prevent decline in eGFR. Funding: Commercial Support - Eledon Pharmaceuticals
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".