picankibart (IBI-112) / Innovent Biologics - LARVOL DELTA

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

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

Enrollment open • Dermatology • Immunology • Psoriasis

IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment (clinicaltrials.gov) - P3 | N=550 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) 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=160 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

A Study of IBI112 in Chinese Patients With Psoriasis Who Were Previously Treated With Biogolics (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P2 trial • Dermatology • Immunology • Psoriasis

Safety and pharmacokinetics of IBI112, an IL-23 monoclonal antibody, in Chinese healthy volunteers: A first-in-human phase 1 study. (PubMed, Expert Opin Investig Drugs) - P1 | "IBI112 was well tolerated and safe at SC or IV dose up to 600 mg, and showed a linear PK characteristics at SC dose from 5 to 300 mg. ClinicalTrial.gov NCT04511624."

Clinical • Journal • P1 data • PK/PD data • Dermatology • Immunology • Psoriasis • IL23A

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

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

A Study to Evaluate IBI112 in the Treatment of Psoriasis With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis • Psoriatic Arthritis

Innovent Announces First Patient Dosed in a Phase 3 Clinical Trial (CLEAR) of Picankibart (Anti-IL23p19 Monoclonal Antibody) in Patients with Moderate-to-Severe Plaque Psoriasis (PRNewswire) - "Innovent Biologics...announced that the first patient with moderate-to-severe plaque psoriasis has been successfully dosed in a Phase 3 clinical trial (CLEAR) of picankibart (R&D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL23p19) antibody injection."

Trial status • Immunology • Psoriasis

A Study to Evaluate IBI112 in the Treatment of Psoriasis With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P3 trial • 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. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Dec 2023 ➔ Dec 2024

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

Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects (clinicaltrials.gov) - P1 | N=46 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2021 ➔ Jul 2022 | Trial primary completion date: Sep 2021 ➔ Jul 2022

Trial completion • Trial completion date • Trial primary completion date

A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=250 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Trial completion date: Jan 2023 ➔ Sep 2023

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