724 - A phase 2b, randomized, double-blinded, parallel-group, placebo-controlled study to evaluate the efficacy and safety of rezpegaldesleukin in adults with severe to very-severe alopecia areata
Bibliographic record
Abstract
Abstract Introduction & Objectives Alopecia areata (AA) is a chronic inflammatory skin disorder resulting in patchy, non-scaring hair loss. The pathogenesis for AA involves loss of immune privilege for the hair follicle through overactivity of the Th1 and Th17 cells and dysfunction of regulatory T cells (Treg).1 Rezpegaldesleukin (REZPEG: NKTR-358) is a polyethylene glycol (PEG)-conjugated recombinant human interleukin 2 (rhIL-2) with the ability to selectively promote the activation and up-to 12-fold expansion of Tregs, while having relatively minimal effect on conventional T cells (Tcons).2 REZPEG is a biologic therapy and represents a potential novel therapeutic approach for patients with severe to very-severe AA. There are currently no biologic therapies approved for the treatment of AA. REZPEG has previously demonstrated clinical activity in patients with chronic inflammatory skin conditions, including atopic dermatitis (AD), psoriasis, and systemic lupus erythematous. Specifically, a Phase 1b study of REZPEG for patients with moderate-to-severe AD demonstrated a rapid time to response (2-4 weeks) during induction therapy and a prolonged durability of response, i.e., throughout the 36-week follow-up after cessation of therapy. These results support further development of REZPEG for patients with moderate to severe AD (phase 2b study ongoing, NCT06136741) and other inflammatory skin diseases, including AA. Objective Evaluate the efficacy and safety of REZPEG in patients with severe alopecia areata. Materials & Methods We are conducting a Phase 2b, randomized, double-blinded, placebo-controlled, international, multicenter study of REZPEG vs placebo for JAK-inhibitor naïve patients with severe to very severe AA. Eligibility requires adult males (aged 18-60 years) or adult females (aged 18-70) with severe to very severe AA with the following inclusion criteria: baseline Severity Alopecia Tool (SALT) score ≥ 50, stable hair loss for 6-months, current episode of severe AA of less than 8-years, and no hair loss from causes other than AA. Patients will be randomly assigned in a 3:3:2 ratio to 2 different REZPEG dosing regimens vs. placebo, administered subcutaneously, during the treatment period and all patients will undergo an extended follow-up. The primary endpoint for this study is the percent change from baseline in SALT score at end of treatment period. Key secondary/exploratory endpoints include the following: percent change from baseline in SALT score at other assessed timepoints, proportions with ≥ 50%, 75%, 90% reduction in SALT at end of treatment period and other assessed timepoints, proportion of patients with absolute SALT score ≤ 10, ≤ 20, ≤ 30, ≤ 50 at end of treatment period and other assessed timepoints, safety/tolerability, various patient reported outcomes (PROs), pharmacokinetics, and pharmacodynamics. Results Trial ongoing (NCT 06340360). Conclusion REZPEG is a novel regulatory T cell stimulating therapy that may confer prolonged therapeutic benefit for patients with chronic inflammatory skin conditions, including AA and AD. This phase 2b trial is evaluating the efficacy and safety of multiple dosing regimens of REZPEG in JAK-inhibitor and biologic-therapy naïve patients with severe to very severe alopecia areata.
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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) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 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) | 0.012 | 0.002 |
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".