Picankibart Sets New Bar For Psoriasis Treatment: CLEAR-2 Trial Confirms Sustained Skin Clearance And Quality-Of-Life Gains

Innovent Biologics unveiled compelling Phase 3 evidence supporting PECONDLE (picankibart injection) as a game-changer in moderate-to-severe plaque psoriasis management. The CLEAR-2 randomized withdrawal study, involving 566 Chinese patients, demonstrated that quarterly maintenance therapy dramatically outperforms treatment cessation—a critical finding for chronic disease management where relapse prevention matters most.

The Core Finding: Maintenance Therapy Sustains Superior Skin Clearance

When patients receiving picankibart achieved 90% improvement in Psoriasis Area Severity Index (PASI 90) scores, researchers randomly assigned them to either continued quarterly injections (100 mg or 200 mg) or placebo withdrawal. By Week 56, the maintenance-treated cohorts maintained PASI 90 response at remarkably high rates: 89.3% in the 100 mg group and 90.1% in the 200 mg group. This stood in stark contrast to the withdrawal groups, where only 37.7% and 51.7% sustained this level of clearance, respectively (P<0.0001).

The magnitude of difference underscores a fundamental principle in biologic therapy: consistent dosing prevents the relapse cycle that characterizes many skin diseases.

Beyond Skin Clearance: Comprehensive Clinical Wins

Secondary efficacy endpoints painted an even broader picture of therapeutic benefit. Patients on maintenance regimens achieved higher rates across every measured parameter:

• PASI 75 (75% improvement) and PASI 100 (complete skin clearance) were significantly more common in maintenance groups
• Physician’s Global Assessment (sPGA) scores of 0/1 (clear or almost clear skin) improved dramatically
• Dermatology Life Quality Index (DLQI) scores of 0/1—indicating minimal to no impact on daily functioning—were substantially elevated in treatment-continued groups

All comparisons against withdrawal groups reached statistical significance (P<0.0001), suggesting that picankibart’s benefits extend beyond dermatological markers to tangible improvements in patients’ everyday quality of life.

Disease Modification And Durability: The Depth Of Effect

Perhaps most intriguingly, patients who stopped therapy showed noteworthy durability of effect. Median time to relapse in withdrawal groups stretched to 20.4 weeks and 24.6 weeks across dosing arms—suggesting that picankibart may induce clinically meaningful disease modification. Nearly half of patients maintained PASI 90 response even six months after discontinuation, a finding that hints at deeper immunological changes beyond simple symptom suppression.

Safety Profile Remains Consistent

Throughout the trial, picankibart maintained the tolerability profile established in earlier-phase studies, with no novel safety concerns identified. This consistency—particularly important for quarterly dosing regimens—supports long-term compliance and patient confidence.

Market Context And Clinical Significance

PECONDLE became the first China-developed IL-23p19 monoclonal antibody to secure National Medical Products Administration (NMPA) approval in November 2025, filling a therapeutic niche in a psoriasis market increasingly populated by biologic alternatives. The CLEAR-2 data validate quarterly dosing as an effective maintenance strategy for achieving and sustaining deep remission in a substantial majority of treatment-responsive patients, positioning this agent as a meaningful option for systemic therapy candidates with moderate-to-severe disease.