soficitinib (ICP-332) / InnoCare - LARVOL DELTA

InnoCare Announces Phase III Study Results of TYK2 Inhibitor Soficitinib Meet Primary Endpoint in Patients with Atopic Dermatitis (GlobeNewswire) - "The study demonstrated that soficitinib achieved the primary endpoint with statistical significance and clinically meaningful improvement. In addition, multiple secondary endpoints were successfully met, demonstrating a consistent treatment effect across efficacy measures. Soficitinib also showed a good safety profile, which was consistent with previous clinical studies, and no new safety signals were identified. Detailed efficacy and safety data from the study will be presented at upcoming international scientific congresses and/or academic journal."

P3 data • Atopic Dermatitis

ICP-CL-00609: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ICP-332 in Participants with Prurigo Nodularis (clinicaltrialsregister.eu) - P1/2 | N=6 | Not yet recruiting | Sponsor: Innocare Pharma Inc.

New P1/2 trial • Immunology • Prurigo Nodularis

Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2/3 | N=344 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Phase I Study of ICP-332 in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: InnoCare Pharma Inc. | Recruiting ➔ Completed

Trial completion

Soficitinib (ICP-332) is being evaluated across five autoimmune indications with multiple data readouts expected: (InnoCare Pharma Press Release) - "Chronic Spontaneous Urticaria (“CSU”): The Phase II/III clinical study of soficitinib (ICP-332) in patients with moderate to severe CSU is ongoing. The Phase II portion is currently enrolling patients, with data readout expected upon completion of enrollment, and the Phase III planned to start thereafter. Psoriasis: The Phase II clinical study of soficitinib (ICP-332) in patients with moderate to severe plaque psoriasis is ongoing, with patient enrollment in progress and data readout expected upon completion of enrollment and follow-up."

P2 data • Trial status • Chronic Spontaneous Urticaria • Psoriasis

TYK2 Franchise: Broad T-Cell-Driven Autoimmune Coverage - Soficitinib (ICP-332) (InnoCare Pharma Press Release) - "Soficitinib (ICP-332) is being evaluated across five autoimmune indications with multiple data readouts expected: Atopic Dermatitis: The Phase III clinical study of soficitinib (ICP-332) in patients with moderate to severe atopic dermatitis completed patient enrollment in late 2025, primary efficacy analysis expected in mid-2026. Vitiligo: The Phase II/III clinical study of soficitinib (ICP-332) in patients with non-segmental vitiligo is ongoing. The Phase II portion has completed patient enrollment, with data readout expected in the third quarter of 2026, and the Phase III stage is planned to start subsequently."

P2 data • P3 data • Trial status • Atopic Dermatitis • Vitiligo

InnoCare Pharma…announced today that the first patient has been dosed in the Phase II/III clinical trial of novel TYK2 inhibitor soficitinib (ICP-332) for the treatment of chronic spontaneous urticaria (CSU) (GlobeNewswire)

Trial status • Chronic Spontaneous Urticaria

Study Results of Novel TYK2 Inhibitor Soficitinib in Patients with AD Published by JAMA Dermatology (GlobeNewswire) - "Soficitinib achieved multiple efficacy endpoints in the study. Percentage improvement from baseline in EASI at week 4 were 78.2% in the 80-mg soficitinib group, 72.5% in the 120-mg soficitinib group, and 16.7% for those receiving placebo. There was a statistically significant higher EASI-75 response rate with both soficitinib doses (64.0% for each; difference vs placebo, 56.0%) than with placebo and a greater percentage of Validated Investigator Global Assessment for Atopic Dermatitis score of 0 or 1 and improvement of 2 or more points at week 4 in the 80-mg soficitinib group vs placebo (36.0%; difference vs placebo, 32.0%, P=0.005)."

P2 data • Atopic Dermatitis

Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2/3 | N=344 | Not yet recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

New P2/3 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Safety and Efficacy of ICP-332 for Moderate to Severe Atopic Dermatitis: A Phase 2 Randomized Clinical Trial. (PubMed, JAMA Dermatol) - P2 | "In this phase 2 randomized clinical trial, ICP-332 demonstrated a favorable safety profile and encouraging efficacy, supporting further development for AD. ClinicalTrials.gov Identifier: NCT05702268."

Clinical • Journal • P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • TYK2

Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis (clinicaltrials.gov) - P2 | N=135 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Prurigo Nodularis

Efficacy and Safety of ICP-332 Versus Placebo in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=172 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

InnoCare Pharma…announced today the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct a Phase II/III clinical trial of novel TYK2 inhibitor soficitinib (ICP-332) for the treatment of chronic spontaneous urticaria (CSU) (GlobeNewswire)

New P2/3 trial • Chronic Spontaneous Urticaria

InnoCare Pharma…announced today that the first patient has been dosed in the global Phase II clinical trial of its novel TYK2 inhibitor, Soficitinib (ICP-332), for the treatment of patients with prurigo nodularis in China (GlobeNewswire)

Trial status • Prurigo Nodularis

Efficacy and Safety of ICP-332 Versus Placebo in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=172 | Not yet recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

New P2 trial • Dermatology • Immunology • Psoriasis

Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis (clinicaltrials.gov) - P2 | N=135 | Not yet recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

New P2 trial • Immunology • Prurigo Nodularis

ICP-332 in Subjects With Non-segmental Vitiligo (clinicaltrials.gov) - P2/3 | N=603 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

New P2/3 trial • Dermatology • Immunology • Vitiligo

InnoCare Announces First Patient Dosed in the Phase II/IIII Clinical Trial of TYK2 Inhibitor Soficitinib for Treatment of Vitiligo in China (Businesswire) - "InnoCare Pharma...announced today that the first patient has been dosed in the Phase II/III clinical trial of its novel TYK2 inhibitor, Soficitinib (ICP-332), for the treatment of patients with non-segmental vitiligo in China."

Trial status • Dermatology • Immunology

ICP-332 in Subjects with Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=552 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

InnoCare Announces First Subject Dosed in the Phase III Registrational Trial of TYK2 Inhibitor ICP-332 for the Treatment of Atopic Dermatitis in China (Businesswire) - "ICP-332 is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders...with broad market prospects."

Trial status • Atopic Dermatitis

Recent progress in tyrosine kinase 2 inhibitors for atopic dermatitis. (PubMed, Expert Opin Investig Drugs) - "We also provide a detailed assessment of ICP-332 efficacy, safety, and potential adverse effects in moderate-to-severe AD. Janus kinase inhibitors that have been recently approved have shown promise for the treatment of AD, especially for patients with severe phenotypes. Preliminary findings from randomized controlled trials suggest that TYK2 inhibitors exhibit rapid efficacy and acceptable safety in the management of AD; however, additional investigations, including long-term trials, are warranted to fully understand their efficacy and safety profile."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • TYK2

Phase I Study of ICP-332 in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: InnoCare Pharma Inc.

New P1 trial

InnoCare Announces First Subject Dosed in Clinical Trial of TYK2 Inhibitor ICP-332 in the U.S. (Businesswire) - "InnoCare Pharma...announced that the first subject has been dosed in clinical trial of the Company's novel TYK2 (Tyrosine Kinase 2) inhibitor ICP-332 in the United States."

Trial status • Atopic Dermatitis

InnoCare Announces Clearance of Clinical Trial of TYK2 Inhibitor ICP-332 by U.S. FDA (Businesswire) - "InnoCare Pharma...announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Company's novel TYK2 (Tyrosine Kinase 2) inhibitor, ICP-332."

IND • Atopic Dermatitis • Immunology

Efficacy and Safety of a Highly Selective Oral TYK2/JAK1 Inhibitor, ICP-332, in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase II, Randomized, Placebo-Controlled Trial (AAD 2024) - No abstract available

Clinical • Late-breaking abstract • P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • TYK2