gumokimab (AK111) / Akesobio - LARVOL DELTA

A Clinical Study of AK139 in Healthy Subjects (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Akeso

New P1 trial

Next-Generation Anti-IL-17 Agents for Psoriatic Disease: A Pipeline Review. (PubMed, Am J Clin Dermatol) - "Key agents under investigation include netakimab, vunakizumab, xeligekimab, gumokimab, HB0017, CJM 112, JS005, 608, LZM012, ZL-1102, izokibep, sonelokimab, DC-806, DC-853, and LEO 153339. Both preclinical and clinical trial data for each agent are summarized, with an emphasis on their efficacy, adverse effects, immunogenicity, and future outlooks."

Journal • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=351 | Completed | Sponsor: Akeso | Active, not recruiting ➔ Completed | Trial primary completion date: Dec 2023 ➔ Aug 2024

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

To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=454 | Completed | Sponsor: Akeso | Recruiting ➔ Completed | N=150 ➔ 454 | Trial primary completion date: Aug 2024 ➔ Dec 2024

Enrollment change • Trial completion • Trial primary completion date • Dermatology • Immunology • Psoriasis • Psoriatic Arthritis

Akeso's Gumokimab Monoclonal Antibody (IL-17) New Drug Application for the Treatment of Moderate to Severe Psoriasis Accepted by NMPA (PRNewswire) - "Akeso...is pleased to announce that the New Drug Application (NDA) of its internally-developed IL-17-targeting monoclonal antibody gumokimab (AK111) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of moderate to severe plaque psoriasis....Gumokimab has been evaluated in four clinical studies involving patients with moderate to severe plaque psoriasis, including one pivotal Phase III clinical trial (AK111-301) and three supportive studies. Efficacy data show that gumokimab acts quickly, with significant therapeutic improvement observed after just 2 weeks of treatment."

China filing • Psoriasis

Efficacy and Safety of AK111 in Patients with Moderate to Severe Plaque Psoriasis: Results from a Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Clinical Study (EADV 2024) - "AK111 was generally safe and well tolerated, also able to improve PASI90, PASI 75 and sPGA0/1 response rate in patients with moderate to severe plaque psoriasis."

Clinical • P2 data • Dermatology • Immunology • Infectious Disease • Inflammation • Psoriasis • IL17A

A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis (clinicaltrials.gov) - P3 | N=510 | Recruiting | Sponsor: Akeso

New P3 trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis (clinicaltrials.gov) - P2 | N=125 | Completed | Sponsor: Akeso | Active, not recruiting ➔ Completed

Trial completion • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis • Psoriatic Arthritis

A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=350 | Active, not recruiting | Sponsor: Akeso

New P3 trial • Dermatology • Immunology • Psoriasis • Psoriatic Arthritis

A Phase II Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Akeso

New P2 trial • Dermatology • Immunology • Psoriasis • Psoriatic Arthritis

Efficacy and safety of AK111, in patients with active ankylosing spondylitis: results from a randomized, double-blind, placebo-controlled, phase II clinical study (P803) (IMMUNOLOGY 2023) - "No death was reported. ConclusionAK111 was generally safe and well tolerated, also able to improve ASAS20/ASAS40 response in Chinese subjects with active ankylosing spondylitis."

Clinical • P2 data • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis (clinicaltrials.gov) - P2 | N=251 | Completed | Sponsor: Akeso | Active, not recruiting ➔ Completed | Trial primary completion date: Dec 2021 ➔ Feb 2023

Trial completion • Trial primary completion date • Dermatology • Immunology • Psoriasis • IL17A

Efficacy, Safety and Pharmacokinetics of IL-17 Monoclonal Antibody Injection (AK111) in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blinded, Placebo-Controlled Phase Ib Multidose Escalation Clinical Study. (PubMed, Dermatol Ther (Heidelb)) - P1 | "After moderate-to-severe plaque psoriasis subjects received multiple subcutaneous AK111 injections of 150-450 mg, AK111 exposure increased in a roughly dose-proportional relationship. AK111 was safe and tolerable. In subjects with moderate-to-severe plaque psoriasis, AK111 demonstrated encouraging preliminary efficacy, which was sustained for a relatively long time after the last dose administration."

Clinical • Journal • P1 data • PK/PD data • Dermatology • Diabetes • Immunology • Psoriasis • IL17A

Population pharmacokinetic/pharmacodynamic analysis of AK111, an IL-17A monoclonal antibody, in subjects with moderate-to-severe plaque psoriasis. (PubMed, Front Pharmacol) - "The simulation results confirmed that all of the predicted PASI90 response rates at week 12 were higher than 60% at 150 and 300 mg dose levels with different regimens and could reach higher than 80% at week 24. We hope this first PK/PD study of AK111 in Chinese moderate-to-severe plaque psoriasis patients will be of help in the further clinical development of AK111 and provide a reference to the dosage optimization for similar antibodies with a long half-life."

Journal • PK/PD data • Dermatology • Immunology • Psoriasis • IL17A

A Study of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Akeso

New P1 trial • Dermatology • Immunology • Psoriasis

A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis (clinicaltrials.gov) - P2 | N=125 | Active, not recruiting | Sponsor: Akeso

New P2 trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Akeso’s IL-17A MONOCLONAL ANTIBODY (GUMOKIMAB) COMPLETION OF PATIENT ENROLLMENT IN PHASE II CLINICAL TRIAL FOR THE TREATMENT OF ANKYLOSING SPONDYLITIS (PRNewswire) - "Akeso...announces that Gumokimab (IL-17A monoclonal antibody, AK111), an innovative drug independently developed by the Company for the treatment of active ankylosing spondylitis has been completed. Such clinical trial aims to evaluate the efficacy and safety of Gumokimab for the treatment of patients with active ankylosing spondylitis....The assessment of primary endpoints of Gumokimab for treatment of all subjects with moderate-to-severe plaque psoriasis has been completed, and it is expected to advance to phase III clinical trial in early 2022."

Enrollment closed • New P3 trial • Ankylosing Spondylitis • Immunology • Psoriasis

A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis (clinicaltrials.gov) - P2; N=250; Active, not recruiting; Sponsor: Akeso

Clinical • New P2 trial • Dermatology • Immunology • Psoriasis • IL17A

A Study of AK111 in Healthy Subjects (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Akesobio Australia Pty Ltd

Clinical • New P1 trial • Dermatology • Immunology • Psoriasis • IL17A

A Study of AK111 in Healthy Subjects (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Akesobio Australia Pty Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Dermatology • Immunology • Psoriasis • IL17A

A Study of AK111 in Healthy Subjects (clinicaltrials.gov) - P1; N=68; Completed; Sponsor: Akesobio Australia Pty Ltd; Recruiting ➔ Completed; N=36 ➔ 68; Trial completion date: May 2019 ➔ Feb 2020; Trial primary completion date: May 2019 ➔ Jan 2020

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis • IL17A

The first patient of Kangfang Biological (09926-HK) new drug AK111 was successfully enrolled [Google translation] (Finet Group) - "Kangfang Bio-B (09926-HK) announced that...drug AK111...in the first phase 1b clinical trial in China, the first case of moderate to severe plaque psoriasis...patient has successfully completed enrollment and administration....AK111 has previously received IND approval for psoriasis in China...completed a phase I study on healthy subjects...safe and well tolerated at a single dose...currently conducting clinical studies of multiple dosing in patients with moderate to severe psoriasis in China."

IND • Trial completion • Trial status • Immunology • Psoriasis