Pecondle (picankibart injection) / Innovent Biologics - LARVOL DELTA

Innovent Announces PECONDLE (Picankibart Injection) Phase 3 Study (CLEAR-2) Meets Endpoints, Delivering Superior Long-Term Management Solution for Moderate-to-Severe Psoriasis (PRNewswire) - "A total of 566 participants were enrolled and all received picankibart treatment through Week 32....At Week 56, the proportions of participants maintaining PASI 90 response were 89.3% in the 100 mg group and 90.1% in the 200 mg group for picankibart maintenance treatment, both significantly higher than the corresponding withdrawal groups (37.7% and 51.7%, respectively; P < 0.0001 for both)....All secondary efficacy endpoints were successfully met, with significantly higher proportions of participants in the 100 mg and 200 mg picankibart maintenance groups versus the corresponding withdrawal groups achieving PASI 75, PASI 100 (complete skin clearance), sPGA score of 0 or 1, sPGA score of 0 (clear skin), and DLQI score 0/1 (dermatology life quality index) at Week 56 (P < 0.0001 for all comparisons)."

P3 data • Psoriasis

A Study to Evaluate Efficacy and Safety of IBI112 in Adolescent Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=104 | Not yet recruiting | Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

New P3 trial • Dermatology • Immunology • Psoriasis

China’s First Domestic IL-23p19 Monoclonal Antibody: Innovent’s PECONDLE (Picankibart Injection) Received NMPA Approval (PRNewswire) - "This approval was based on a pivotal registrational Phase 3 clinical trial, CLEAR-1 (NCT05645627), which evaluated the efficacy and safety of picankibart in Chinese participants with moderate-to-severe plaque psoriasis."

China approval • Psoriasis

A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=150 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed

Trial completion • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy of Picankibart in Moderate-to-Severe Plaque Psoriasis Between Biologic-Experienced and Biologic-Naive Patients: A 52-Week results from the Phase 3 CLEAR-1 Study (EADV 2025) - P3 | "Picankibart has demonstrated high efficacy in patients with moderate-to-severe plaque psoriasis regardless of prior use of biologic therapy. Both 100mg picankibart and 200mg picankibart maintained stable efficacy over the 52-week period for above patients."

Clinical • P3 data • Dermatology • Immunology • Psoriasis • IL23A

Efficacy of picankibart in genital psoriasis: results from the phase 3 randomized, double-blind CLEAR-1 study (EADV 2025) - P3 | "Picankibart showed notable efficacy signal on sPGA-G improvement in moderate-to-severe plaque psoriasis patients with perineum involvement. A quick response was observed at week 4 with 50% improvement from baseline. Majority of the patients had nearly clean lesions and more than half of patients achieved skin clear at genital area at week 16, followed by a continued response sustained to week 52."

Clinical • P3 data • Dermatology • Immunology • Ophthalmology • Pruritus • Psoriasis

Efficacy and safety of picankibart in patients with psoriasis who had been treated with biologics: a multicenter, open-label phase 2 trial (EADV 2025) - "In patients with psoriasis, direct switching to picankibart demonstrated meaningful clinical improvements in both skin lesions and quality of life among non-responders to TNF-α or IL-17 inhibitors; responders can directly switch to picankibart without requiring a loading dose regimen, and still maintain clinical benefits under long-interval maintenance therapy. The safety profiles were favorable. These findings support further evaluation in phase 3 trials to further evaluate the efficacy and safety of picankibart in psoriasis patients with prior exposure other biologics."

Clinical • P2 data • Dermatology • Immunology • Infectious Disease • Psoriasis • Respiratory Diseases • IL17A • TNFA

Efficacy of picankibart in moderate-to-severe plaque psoriasis patients with scalp psoriasis: a post-hoc analysis of a phase 3, randomized, double-blind trial (EADV 2025) - P3 | "The results of the post-hoc analysis has demonstrated that for moderate-to-severe plaque psoriasis patients with scalp involvement, picankibart has substantial efficacy with preferable safety. Improvement were observed as early as Week 4 and sustained through Week 52, which suggested a rapid and persistent efficacy profile."

Clinical • P3 data • Retrospective data • CNS Disorders • Dermatology • Immunology • Psoriasis

Efficacy of a new IL-23p19 inhibitor picankibart in the treatment of nail psoriasis: a post-hoc analysis of phase 3 CLEAR-1 study (EADV 2025) - P3 | "The analysis revealed that picankibart can bring notable and sustainable improvement in moderate-to-severe plaque psoriasis patients with nail involvement regardless of the dose regimen defined in CLEAR-1."

Clinical • P3 data • Retrospective data • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Innovent to Present Multiple R&D Results of General Biomedicine Pipeline at the 34th EADV Congress 2025 (PRNewswire) - "Specifically, post hoc analysis of Phase 2 and Phase 3 clinical studies of IBI112 (IL-23p19 monoclonal antibody, picankibart), as well as preclinical study results of IBI3013 (IL-15 monoclonal antibody) and IAR129 (IL-4R/OX40L bispecific antibody) will be showcased via ePoster."

Clinical data • Preclinical • Atopic Dermatitis • Psoriasis

A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy (clinicaltrials.gov) - P3 | N=310 | Recruiting | Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

Innovent Announces a Phase 3 Study of Picankibart (Anti-IL-23p19 Antibody) Completes First Participant Dosing, Exploring Biologics Switching Treatment for Psoriasis Patients with Prior Inadequate Response to Anti-IL-17 Antibodies (PRNewswire) - "Innovent Biologics...announces that the first participant has been successfully dosed in a Phase 3 clinical study of picankibart (recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, R&D code: IB112). This study is the first randomized, double-blind, controlled Phase 3 clinical study evaluating biologics switching in psoriasis patients with prior inadequate response to anti-IL-17 antibody....This study (NCT06945107) is a multi-center, randomized, double-blind, active-controlled Phase 3 clinical study to evaluate the efficacy and safety of switching to picankibart in plaque psoriasis patients with inadequate response to prior anti-IL-17 monoclonal antibody treatment (sPGA score of ≥ 2 and body surface area [BSA] of ≥3%). This study plans to enroll approximately 310 participants..."

Trial status • Psoriasis

A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy (clinicaltrials.gov) - P3 | N=310 | Not yet recruiting | Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

New P3 trial • Dermatology • Immunology • Psoriasis

A Study of IBI112 in Chinese Patients With Psoriasis Who Were Previously Treated With Biologics (clinicaltrials.gov) - P2 | N=152 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Efficacy and safety of picankibart in moderate-to-severe plaque psoriasis: a randomized, double-blind, Phase 3 CLEAR-1 trial (PsoriasisG2C 2024) - "47 Picankibart showed superior efficacy to placebo in the treatment of moderate-to-severe plaque psoriasis. The safety profile of picankibart was favourable with no unexpected safety findings."

Clinical • P3 data • Dermatology • Immunology • Psoriasis

A Study to Evaluate IBI112 in the Treatment of Psoriasis With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=500 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Aug 2024

Trial completion • Trial completion date • Dermatology • Immunology • Psoriasis • Psoriatic Arthritis

Innovent Announces Results of a Phase 2 Study of Picankibart (Anti-IL-23p19 Antibody) in Plaque Psoriasis, Showing Efficacy in Patients with Prior Inadequate Response to IL-17 Biologics (PRNewswire) - P2 | N=152 | NCT05970978 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "Of the 152 enrolled patients in the study, 83 (54.6%) were classified as inadequate responders, with a median disease course of 12 years. Among them, 80 (96.4%) had been treated with IL-17 inhibitors, 90.4% had a baseline sPGA ≥2 , and 86.7% had a baseline BSA ≥3%. The primary endpoint was met with rapid onset of efficacy. The efficacy in clearing lesions for patients with inadequate response suggests best-in-class performance. Nearly half (48.2%, 40/83) of patients with prior inadequate response at baseline met the primary endpoint, achieving an sPGA of 0 or 1 and BSA of <3%; For secondary endpoints, of the 65 patients with baseline sPGA of ≥2 and BSA of ≥3%, the majority (64.6%,42/65) achieved sPGA of 0 or 1, and 15 patients (18.1%) reached sPGA of 0..."

P2 data • Psoriasis

Innovent Announces Phase 2 Clinical Study of Picankibart (IBI112) in Chinese Patients with Ulcerative Colitis Met Primary Endpoint (PRNewswire) - P2 | N=150 | NCT05377580 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "Innovent Biologics...announces that primary endpoint of 12-week induction period was met in a multicenter, randomized, double-blind, placebo-controlled phase 2 clinical study....A total of 150 subjects were enrolled and randomized in a 1: 1: 1 ratio....The proportion of subjects who achieved clinical remission was significantly higher in the picankibart 200 mg group (20.0%) and 600 mg group (14.0%) than in the placebo group (2.0%; p < 0.05). Clinical response was achieved in 54.0% and 68.0% of subjects in the picankibart 200 mg and 600 mg groups, respectively, which was significantly higher than in the placebo group (22.0%; p < 0.001)....Detailed data will be further analyzed and published at future academic congresses or in clinical journals."

P2 data • Ulcerative Colitis

Innovent Announces NMPA Acceptance of NDA for Picankibart (Anti-IL-23p19 Antibody) for Treating Moderate to Severe Plaque Psoriasis (PRNewswire) - "Innovent Biologics...announces that the New Drug Application (NDA) for picankibart injection, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of moderate to severe plaque psoriasis....This NDA acceptance is based on positive results from the Phase 3 registrational clinical study CLEAR-1 (NCT05645627) in Chinese patients with moderate to severe plaque psoriasis."

China filing • Psoriasis

IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment (clinicaltrials.gov) - P3 | N=550 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study of IBI112 in Chinese Patients With Psoriasis Who Were Previously Treated With Biologics (clinicaltrials.gov) - P2 | N=152 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

Innovent Announces Picankibart (IBI112) Achieved Primary Endpoints in a Phase 3 Clinical Trial in Treating Moderate to Severe Plaque Psoriasis, and Plans to Submit NDA to the NMPA (PRNewswire) - P3 | N=500 | CLEAR-1 (NCT05645627) | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "Innovent Biologics...announced that picankibart...has met all the primary endpoints and key secondary endpoints in the Phase 3 registrational study (CLEAR-1) in Chinese subjects with moderate to severe plaque psoriasis. CLEAR-1 is global the first Phase 3 registration study in IL-23p19 class that reported over 80% of subjects achieved PASI 90 after 16 weeks of treatment in psoriasis patients. Innovent plans to submit a new drug application (NDA) for picankibart in the treatment of psoriasis to the Center for Drug Evaluation (CDE) of National Medical Product Administration (NMPA)....The study results showed that co-primary endpoints of CLEAR-1 were successfully met: at week 16, significantly higher proportion of subjects receiving picankibart achieved PASI 90 and sPGA 0 or 1 compared with placebo (80.3% vs. 2.0% for PASI 90 and 93.5% vs. 13.1% for sPGA 0/1, both p<0.0001)."

China filing • P3 data • Psoriasis

A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=250 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis • Psoriatic Arthritis

A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Trial completion date: Jun 2025 ➔ Sep 2025

Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis