Oturkibart Posts 74.5% Itch Response in Phase 3 Prurigo Nodularis Trial
Updated
At 24 weeks, 74.5% of patients with prurigo nodularis receiving oturkibart achieved at least a 4-point reduction in weekly Worst Itch Numeric Rating Scale (WI-NRS) versus 29% on placebo (P<.0001), in a 412-patient phase 3 multicenter Chinese trial reported at the European Academy of Dermatology and Venereology (EADV) 2026 Congress in Vienna.
The monoclonal antibody binds the IL-4 receptor α subunit, blocking IL-4 and IL-13 signaling. "Deep pruritus relief was achieved in nearly 75% of patients, and it was sustained during the subsequent 28-week open-label extension," said Jianzhong Zhang, MD, professor and chairman of dermatology at Peking University People's Hospital, Beijing.
The trial randomized adults inadequately controlled on topical corticosteroids to 450 mg subcutaneous oturkibart or placebo every two weeks. The primary endpoint was at least a 4-point WI-NRS reduction on the 0–10 scale, where scores of 7 or higher indicate severe disease.
Among 61 patients (14.8%) who continued topical corticosteroids or topical calcineurin inhibitors, oturkibart responses hit 79.7% versus 13.7% for placebo (P<.0001). Investigator-stratified analyses deepened the treatment effect in this subgroup.
How did lesion clearance compare with itch relief?
Lesion clearance lagged behind itch relief but favored oturkibart. IGA 0/1 curves separated at week 4 and reached statistical significance at week 15 (16.9% vs 8.0%; P<.01). The gap widened to 34.7% versus 11.1% at week 24 (P<.001).
IGA gains continued through the 52-week extension. Among patients who stayed on oturkibart, 66.9% reached IGA 0/1 at week 52, compared with 49.2% in the placebo-to-oturkibart switch group.
What did quality-of-life instruments show?
Dermatology Life Quality Index (DLQI) and Hospital Anxiety and Depression Scale (HADS) scores improved steadily on oturkibart. "After switching from placebo to oturkibart, the magnitude of improvements in DLQI and HADS increased markedly, approaching the continuous oturkibart group by week 52," Zhang said.
Across the entire study population at week 52, 55.1% achieved complete itch resolution (WI-NRS ≤1) and 76.7% reached a major response (WI-NRS ≤2).
Why did slow responders at week 24 still improve?
Roughly a quarter of participants (25.5%) had not hit the primary endpoint at week 24. Most of these slow responders (81.6%) achieved ≥4-point WI-NRS improvement by week 52. Within that subgroup, 51.8% reached IGA 0/1 skin clearance at the same time point.
The data argue against abandoning therapy in patients without early WI-NRS response. Continued exposure, the investigators suggested, can deliver delayed benefit.
How does the safety profile compare with dupilumab?
Adverse events during the blinded phase did not differ meaningfully between arms. Serious adverse events occurred in 4.9% of oturkibart patients versus 5.3% on placebo; discontinuations ran 1.5% versus 1.9%.
Selected adverse events at 24 weeks:
- Injection-site reactions: 2.9% vs 2.4%
- Infection: 36.9% vs 33.0%
- Herpes-related events: 0.5% vs 2.4%
- Conjunctivitis: 1.9% vs 1.0%
The conjunctivitis figure drew pointed questions from Peter Wolf, MD, professor and chair of dermatology at the University of Graz, who compared the 1.9% rate with the 10–15% typically reported for dupilumab, the first IL-4Rα antibody approved for prurigo nodularis.
Zhang acknowledged the numerical contrast but declined to speculate on mechanism. "These agents cannot be considered interchangeable without head-to-head studies," he told the audience.
Oturkibart, if cleared by regulators, would become the second IL-4Rα monoclonal antibody indicated for prurigo nodularis. Head-to-head data against dupilumab and the agent's regulatory timeline remain the next checkpoints.
Zhang reported financial relationships with AbbVie, Bristol-Myers Squibb, Cutia Genrix Bio, InventisBio, Jemincare, Jiangsu Hengrui Medicine, Highlight, Innovent Biologics, Longwood, Eli Lilly, LEO Pharma, Novartis, Pfizer, Sanofi, Shenzhen Kangzhe, Takeda, Theoderma, TopAlliance, Viatris, Xian Janssen, and Zelgen. Wolf reported no potential conflicts of interest.
Original: medscape.com
Daniel Okafor
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Staff writer covering people, launches and day-to-day practice in Clinical dermatology, inflammatory skin disease and biologics at Derm Field.