ICP-488 / InnoCare - LARVOL DELTA

Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

InnoCare Announces First Patient Dosed in the Phase III Registrational Trial of ICP-488 for the Treatment of Psoriasis in China (Businesswire) - "InnoCare Pharma...announced today that the first patient has been dosed in the Phase III registrational trial of the Company’s novel TYK2 (Tyrosine Kinase 2) inhibitor, ICP-488, for the treatment of moderate-to-severe plaque psoriasis in China."

Trial status • Psoriasis

Data of InnoCare's ICP-488 for the Treatment of Psoriasis Presented at Late Breaking Oral Presentation of 2025 AAD (Businesswire) - P2 | N=129 | NCT06109818 | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | "The primary endpoint was the percentage of subjects who achieved at least a 75% improvement from baseline in the Psoriasis Area and Severity Index score (PASI 75) at week 12. At week 12, the percentage of patients achieving PASI 75 was significantly superior in the ICP-488 6 mg QD group (77.3%) and the 9 mg QD group (78.6%) than that of the placebo group (11.6%) (P<0.0001); the percentages of subjects achieving PASI 90 and sPGA of 0 (clear) or 1 (almost clear) were also significantly higher in the ICP-488 6 mg QD group (36.4%, 70.5%) and 9 mg QD group (50.0%, 71.4%) compared to the placebo group (0%, 9.3%)(P<0.0001). All treatment emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) and were mild or moderate."

Late-breaking abstract • P2 data • Psoriasis

Efficacy and Safety of a Highly Selective Oral TYK2 Inhibitor, ICP-488, in Patients with Moderate-to-Severe Plaque Psoriasis: A Phase II, Randomized, Double-blinded, Placebo-Controlled Trial (AAD 2025) - No abstract available

Clinical • Late-breaking abstract • P2 data • Dermatology • Immunology • Psoriasis • TYK2

InnoCare: Phase III clinical trial of novel TYK2 allosteric inhibitor ICP-488 for the treatment of psoriasis initiated [Google translation] (Sina Corp) - "...InnoCare Pharma...announced on February 25 that the company's independently developed new TYK2 allosteric inhibitor ICP-488 for the treatment of moderate to severe plaque psoriasis Phase III clinical trial (CTR20250582) has been registered on the China Drug Clinical Trial Registration and Information Disclosure Platform, which means that the first Phase III clinical trial of ICP-488 in China has been initiated....It is understood that this is a multicenter, randomized, double-blind, placebo-controlled Phase III study aimed at evaluating the efficacy, safety and PK characteristics of ICP-488 in the treatment of patients with moderate to severe plaque psoriasis."

Trial status • Psoriasis

Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=129 | Completed | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | Recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

New P3 trial • Dermatology • Immunology • Psoriasis

InnoCare Announces Phase II Study Results of TYK2 Inhibitor ICP-488 Meet Primary Endpoint in Psoriasis Patients (Businesswire) - P2 | N=129 | NCT06109818 | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | "InnoCare Pharma...announced today that phase II clinical study results of novel TYK2 (Tyrosine Kinase 2) inhibitor ICP-488 met the primary endpoint in adult patients with moderate-to-severe plaque psoriasis....Following the 12-week treatment with 6mg or 9mg once-daily dosing of ICP-488, PASI 75 reached 77.3% and 78.6% respectively, compared to 11.6% for patients receiving placebo (p<0.0001); PASI 90 reached 36.4% and 50.0% respectively, compared to 0% for patients receiving placebo (p<0.0001); PASI 100 reached 11.4% and 11.9% respectively, compared to 0% for patients receiving placebo (p<0.05); sPGA 0/1 reached 70.5% and 71.4% respectively, compared to 9.3% for patients receiving placebo (p<0.0001)."

P2 data • Psoriasis

Safety and Pharmacokinetics of a Highly Selective Oral TYK2 Inhibitor (ICP-488): A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study (EADV 2024) - "ICP-488 was safe and well tolerated with favorable PK profiles. ICP-488 showed preliminary efficacy in psoriasis patients within 4 weeks of treatment.. Further clinical development in psoriasis is warranted."

Clinical • PK/PD data • Dermatology • Immunology • Psoriasis • TYK2

InnoCare Announces the Completion of Patient Enrollment in the Phase II Clinical Trial of ICP-488 for the Treatment of Psoriasis (Businesswire) - "InnoCare Pharma...announced the completion of patient enrollment for the phase II clinical trial of ICP-488, a TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor, for the treatment of psoriasis. This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study aimed at evaluating the efficacy, safety, PK and PD characteristics of ICP-488 in Chinese adult patients with moderate to severe plaque psoriasis. A total of 129 patients were enrolled in this study."

Enrollment closed • Psoriasis

Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=129 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=129 | Not yet recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

New P2 trial • Dermatology • Immunology • Psoriasis

InnoCare Releases 2023 Interim Results and Business Highlights (Businesswire) - P1 | N=154 | NCT05451199 | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | "InnoCare is accelerating the ongoing Phase I study of ICP-488 with psoriasis patients, and preliminary PoC is expected by the last quarter of 2023. The Phase II study for psoriasis is in preparation. In Phase I clinical trial with healthy subjects, the single ascending doses (SAD) and multiple ascending doses (MAD) have been completed with ICP-488, demonstrating a well-tolerated safety profile."

P1 data

InnoCare Announces First Psoriasis Patient Dosed in Clinical Trial of TYK2 Allosteric Inhibitor ICP-488 in China (Businesswire) - "InnoCare Pharma...announced today the first psoriasis patient has been dosed in clinical trial of the Company’s TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor ICP-488 in China. In phase I clinical trial, the single ascending doses (SAD) and multiple ascending doses (MAD) have been completed with ICP-488, demonstrating well-tolerated safety profile. The ongoing study with psoriasis patients aims to evaluate the safety and efficacy of ICP-488 in patients with moderate-to-severe psoriasis."

Trial status • Immunology • Psoriasis

A Clinical Study of ICP-488 in Healthy Subjects and Patients With Psoriasis (clinicaltrials.gov) - P1 | N=154 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | N=112 ➔ 154 | Trial completion date: Aug 2023 ➔ Dec 2023 | Trial primary completion date: Jan 2023 ➔ Oct 2023

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

InnoCare Releases 2022 Mid-Year Results and Business Highlights (Businesswire) - "ICP-488: First cohort of phase I trial was completed. ICP-488 is a potent and selective TYK2 allosteric inhibitor, binding to the TYK2 JH2 domain, developed for the treatment of inflammatory diseases such as psoriasis, SLE and inflammatory bowel disease (IBD)."

Trial status • Immunology • Inflammatory Bowel Disease • Psoriasis

A Clinical Study of ICP-488 in Healthy Subjects and Patients With Psoriasis (clinicaltrials.gov) - P1 | N=112 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

InnoCare Announces First Subject Dosed in Clinical Trial of TYK2 JH2 Allosteric Inhibitor ICP-488 in China (Businesswire) - "InnoCare Pharma...announced today that the first subject has been dosed in clinical trial of the Company’s TYK2 JH2 allosteric inhibitor ICP-488 in China. ICP-488 is a potent and selective TYK2 (tyrosine kinase 2) allosteric inhibitor being developed for the treatment of autoimmune diseases such as psoriasis and inflammatory bowel disease (IBD)."

Trial status • Immunology • Inflammatory Bowel Disease

A Clinical Study of ICP-488 in Healthy Subjects and Patients With Psoriasis (clinicaltrials.gov) - P1 | N=112 | Not yet recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

New P1 trial • Dermatology • Immunology • Psoriasis

InnoCare Announces Approval of Clinical Trial of TYK2 JH2 Allosteric Inhibitor ICP-488 in China (PRNewswire) - "InnoCare Pharma...announced today that the company has received Investigational New Drug (IND) approval of clinical trial from the NMPA (National Medical Products Administration) for its TYK2 JH2 allosteric inhibitor ICP-488, which is the Company's third innovative drug for the treatment of autoimmune diseases to enter the clinical stage....As a novel oral TYK2 allosteric inhibitor, ICP-488 will be developed for the treatment of autoimmune diseases such as psoriasis and inflammatory bowel disease (IBD)."

New trial • Immunology • Inflammatory Bowel Disease • Psoriasis

InnoCare Releases 2021 Annual Results and Business Highlights (PRNewswire) - "InnoCare Pharma...announced 2021 annual results as of 31 December 2021....Autoimmune Diseases: ICP-488: A potent and selective TYK2 allosteric inhibitor, binding to the TYK2 JH2 domain, developed for the treatment of inflammatory diseases such as psoriasis and inflammatory bowel disease (IBD). The CDE has approved the clinical trial of ICP-488 in March 2022."

New trial • Inflammatory Bowel Disease • Psoriasis