[Translation] A randomized, double-blind, multicenter phase II clinical trial evaluating the pharmacokinetics, efficacy, safety, and pharmacodynamics of oral ICP-332 in adolescents with moderate to severe atopic dermatitis.

主要目的 - 评估ICP-332在青少年中度至重度AD受试者中的药代动力学（PK）特征。次要目的 - 评估ICP-332治疗青少年中度至重度AD受试者的疗效，安全性和耐受性。探索性目的 - 探索ICP-332在青少年中度至重度AD受试者中的药效动力学（PD）特征。

[Translation]

Primary objective - To evaluate the pharmacokinetic (PK) characteristics of ICP-332 in adolescent subjects with moderate to severe Alzheimer's disease (AD). Secondary objective - To evaluate the efficacy, safety, and tolerability of ICP-332 in adolescent subjects with moderate to severe AD. Exploratory objective - To explore the pharmacodynamic (PD) characteristics of ICP-332 in adolescent subjects with moderate to severe AD.

Start Date14 May 2026

Sponsor / Collaborator

Guangzhou InnoCare Pharma Tech Co., Ltd.

NCT07378527

/ RecruitingPhase 2/3

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of ICP-332 in Moderate to Severe Chronic Spontaneous Urticaria Subjects Inadequately Controlled by Second Generation H1-antihistamines

The purpose of this study is to compare the efficacy and safety of ICP-332 in moderate to severe chronic spontaneous urticaria subjects inadequately controlled by second generation H1-antihistamines

Start Date13 Feb 2026

Sponsor / Collaborator

Beijing InnoCare Pharma Tech Co., Ltd.

NCT07251998

/ RecruitingPhase 2

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ICP-332 in Patients With Moderate to Severe Plaque Psoriasis

The purpose of this study is to compare the efficacy and safety of ICP-332 to placebo in participants with moderate-to-severe plaque psoriasis.

Start Date22 Dec 2025

Sponsor / Collaborator

Beijing InnoCare Pharma Tech Co., Ltd.

100 Clinical Results associated with Soficitinib

100 Translational Medicine associated with Soficitinib

100 Patents (Medical) associated with Soficitinib

Literatures (Medical) associated with Soficitinib

01 Mar 2026·JAMA Dermatology

Safety and Efficacy of ICP-332 for Moderate to Severe Atopic Dermatitis

Article

Author: Zhang, Chunlei ; Yin, Wenhao ; Du, Yue ; Zhou, Wei ; Xu, Ai’e ; Liang, Yunsheng ; Duan, Xinsuo ; Zheng, Jie ; Zhang, Litao ; Yang, Wenlin ; Li, Zhiming ; Zhang, Ruzhi ; Fang, Hong ; Xu, Jinhua ; Lei, Tiechi ; Fan, Danbing ; Tao, Xiaohua ; Zhang, Guoqiang ; Ding, Yangfeng ; Chen, Rixin ; Li, Linfeng ; Ji, Chao

Importance:

ICP-332 is a tyrosine kinase 2 inhibitor currently under investigation for the treatment of atopic dermatitis (AD).

Objective:

To evaluate the safety and efficacy of ICP-332 for moderate to severe AD.

Design, Setting, and Participants:

This double-blind, placebo-controlled, phase 2 randomized clinical trial was conducted between February 6 and November 7, 2023, across 19 centers in China. Individuals aged 18 to 75 years who had diagnosis of AD for 1 year or longer and a history of contraindication or inadequate response to topical therapies were included.

Intervention:

Participants were randomized 1:1:1 to receive ICP-332 at 80 mg or 120 mg, or placebo orally once daily for 4 weeks. Study participants and personnel were blinded to group assignment.

Main Outcomes and Measures:

The primary outcome was safety. The key efficacy outcome was the percentage change from baseline in Eczema Area and Severity Index (EASI) at week 4. Other outcomes included percentages of patients achieving EASI-75 (a ≥75% improvement in EASI) and Validated Investigator Global Assessment for Atopic Dermatitis score of clear (0) or almost clear (1) with 2 or more points improvement.

Results:

This study included 75 patients (mean [SD] age, 37.3 [18.0] years in the ICP-332 groups and 44.5 [17.4] years in the placebo group; 21 women [28%] and 54 men [72%]). Among the 74 patients included in the safety set, 17 of 25 (68%) in the placebo group, 19 of 25 (76%) in the 80-mg ICP-332 group, and 18 of 24 (75%) in the 120-mg ICP-332 group experienced treatment-emergent adverse events, with all events being mild or moderate. The most common adverse event was decreased blood fibrinogen (1 of 25 [4%] in the placebo group, 6 of 25 [44%] in the 80-mg ICP-332 group, and 5 of 24 [21%] in the 120-mg ICP-332 group). Percentage reductions in EASI at week 4 were −78.2% (95% CI, −89.8% to −66.6%) in the 80-mg ICP-332 group, −72.5% (95% CI, −84.3% to −60.7%) in the 120-mg ICP-332 group, and −16.7% (95% CI, −28.7% to −4.6%) for those receiving placebo. Mean differences vs placebo for percentage reductions from baseline at week 4 in EASI were −61.6% (95% CI, −78.4% to −44.7%; P &lt; .001) and −55.8% (95% CI, −72.8% to −38.9%; P &lt; .001) for 80-mg ICP-332 and 120-mg ICP-332, respectively. There was a statistically significant higher EASI-75 response rate with both ICP-332 doses (64.0% for each; difference vs placebo, 56.0%; 95% CI, 34.4%-77.6%; P &lt; .001) 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 ICP-332 group vs placebo (36.0%; difference vs placebo, 32.0%; 95% CI, 11.7%-52.3%; P = .005).

Conclusions and Relevance:

In this phase 2 randomized clinical trial, ICP-332 demonstrated a favorable safety profile and encouraging efficacy, supporting further development for AD.

Trial Registration:

ClinicalTrials.gov Identifier: NCT05702268

02 Oct 2024·EXPERT OPINION ON INVESTIGATIONAL DRUGS

Recent progress in tyrosine kinase 2 inhibitors for atopic dermatitis

Review

Author: Yumei Li ; Yuan Zhou ; Lin Liu ; Yuan Xia ; Qi Liu

INTRODUCTION:

Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by persistent itching. Conventional treatments for AD include topical corticosteroids and calcineurin inhibitors, but there are emerging therapies targeting the JAK-TYK2 pathway that are promising for the treatment of AD.

AREAS COVERED:

This review comprehensively explores the pathogenesis, triggers, clinical manifestations, and conventional treatment options for AD. In addition, we discuss novel therapeutic agents targeting alternative signaling pathways, with a focus on clinical trials evaluating tyrosine kinase 2 (TYK2) inhibitors, including systemic and topical agents. We also provide a detailed assessment of ICP-332 efficacy, safety, and potential adverse effects in moderate-to-severe AD.

EXPERT OPINION:

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.

News (Medical) associated with Soficitinib

17 Jul 2026

·www.biopharmadive.com

Arbutus, Sanofi escalate mRNA patent fights; InnoCare’s TYK2 contender advances

Today, a brief rundown of news involving Arbutus BioPharma and Sanofi, as well as updates from Insmed, InnoCare Pharma and Chai Discovery that you may have missed.Arbutus BioPharma filed three new lawsuits against Pfizer and BioNTech, ratcheting up longstanding legal efforts that aim to prove the companies COVID vaccine infringed on Arbutus patents. In an ongoing suit in the U.S., Arbutus has argued that Pfizer and BioNTech violated patents in using a kind of lipid nanoparticle technology to help deliver their vaccines into cells. The new legal actions broaden that fight into an array of European countries as well as Canada. Arbutus made similar claims against Moderna, leading to a multibillion-dollar settlement earlier this year. It recently received a $178 million payment from Moderna as part of that deal. Ben FidlerSanofi separately initiated two other lawsuits against Pfizer and Moderna in New Jersey. Like Arbutus, Sanofi alleged in court filings that Pfizers COVID shots, and multiple mRNA vaccines developed by Moderna, ran afoul of patents covering lipid nanoparticles. Sanofi inherited some of those patents when it acquired mRNA vaccine developer Translate Bio in 2021. Sanofi is seeking a trial, damages and other financial relief. Ben FidlerInnoCare Pharma revealed this week that its experimental autoimmune drug soficitinib succeeded in two separate clinical trials. On Wednesday, the company said the therapy one of many next-generation TYK2 inhibitors met the main goal of a late-stage study in moderate-to-severe atopic dermatitis. A day later, InnoCare disclosed that soficitinib succeeded in a Phase 2 trial in people with the skin condition vitiligo. Drugs like soficitinib have garnered significant attention from drugmakers in recent years, as they could become oral alternatives to widely used injectables for many autoimmune conditions. Delilah AlvaradoInsmed said Thursday its experimental treatment for pulmonary arterial hypertension continued to help Phase 2 trial enrollees in an open-label extension of a study that read out more than a year ago. Enrollees whod received treprostinil palmitil inhalation powder, or TPIP in the 16-week, placebo-controlled phase of the trial were able to walk 56 meters further on a six-minute test after a year of treatment than they were at the studys start. Those who received the placebo during that initial period and then TPIP afterwards improved by 54 meters. In a note to clients, Leerink Research analyst Joseph Schwartz wrote that the totality of the data continues to suggest the drug is a potentially differentiated treatment for PAH. Insmed has begun a Phase 3 trial that will evaluate TPIPs benefits over 24 weeks. Jonathan GardnerArgenx has partnered with Chai Discovery in a bid to find new antibody drugs. The two companies didnt reveal the specific financial terms underlying the agreement, but through it, Argenx will gain access to Chais AI technology to discover antibodies across therapeutic targets, Chai said Wednesday. The partnership adds to an upswing in AI investments among biopharmaceutical companies, as well as a streak of recent announcements for Chai. Earlier this week, Chai unveiled a collaboration with Novartis and announced the closing of a $400 million Series C round. Delilah Alvarado '

VaccinePhase 2Phase 3mRNAClinical Result

17 Jul 2026

·allsci.com

InnoCare advances soficitinib toward China filing after positive Phase III in atopic dermatitis

InnoCare Pharma Limited (HKEX: 09969) announced that its oral TYK2 inhibitor soficitinib (ICP-332) met the primary endpoint in a Phase III registrational trial in adults with moderate-to-severe atopic dermatitis (AD), clearing the way for a regulatory submission in China. The study also met multiple secondary endpoints, while the safety profile was consistent with previous studies and revealed no new safety signals. Detailed efficacy data will be presented at future medical meetings. The result completes the core evidence package needed for a filing in one of dermatology’s largest markets, where oral treatment options remain limited. The placebo-controlled study enrolled 579 patients, making it one of the largest Phase III trials conducted with a TYK2-selective inhibitor in AD. Soficitinib selectively inhibits TYK2, a member of the JAK kinase family involved in IL-12, IL-23 and type I interferon signaling. Unlike JAK1 inhibitors such as AbbVie’s Rinvoq (upadacitinib) and Pfizer’s Cibinqo (abrocitinib), which carry FDA boxed warnings for serious infections, malignancy, major adverse cardiovascular events and thrombosis, TYK2-selective inhibitors are designed to avoid many of the off-target effects associated with broader JAK inhibition. Whether regulators ultimately view that selectivity as sufficient to differentiate safety labeling remains uncertain. The Phase III success builds on encouraging Phase II results published in JAMA Dermatology earlier this year. In the 75-patient study, once-daily soficitinib achieved statistically significant improvements in EASI scores, EASI-75 responses and itch reduction versus placebo, with adverse events that were generally mild and comparable to placebo. Those data established proof of concept, while the registrational study now provides the evidence required to support regulatory approval. The commercial opportunity remains substantial. Biologic therapies, led by Sanofi and Regeneron’s Dupixent (dupilumab), dominate the moderate-to-severe AD market, while oral therapy is largely limited to JAK1 inhibitors whose boxed warnings have constrained broader use. Bristol Myers Squibb’s Sotyktu (deucravacitinib) validated TYK2 inhibition in plaque psoriasis but has not been approved for AD, leaving the indication without an approved TYK2-targeted therapy. If long-term studies confirm a differentiated safety profile alongside competitive efficacy, soficitinib could emerge as a compelling oral alternative for patients who are unwilling or unable to use biologics. The readout also strengthens InnoCare’s broader autoimmune strategy. Soficitinib is being evaluated in vitiligo, prurigo nodularis, chronic spontaneous urticaria and psoriasis, while the company is separately advancing the allosteric TYK2 inhibitor ICP-488 in Phase III psoriasis studies. A successful approval in AD would provide InnoCare with its first commercial autoimmune product and establish clinical validation for its expanding TYK2 franchise. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Phase 3Clinical ResultPhase 2

16 Jul 2026

·www.fiercebiotech.com

Racing Takeda, InnoCare reports TYK2 inhibitor win in phase 2 vitiligo trial

A phase 2 trial of InnoCare Pharma’s TYK2 inhibitor soficitinib in nonsegmental vitiligo has hit its primary endpoint, clearing the Chinese biotech to advance into the phase 3 part of the study. Incyte has FDA approval for Opzelura, which inhibits all JAKs and TYK2, in the autoimmune skin disorder vitiligo. Developers of TYK2 inhibitors have recognized the opportunity, with Takeda running a phase 2 trial of zasocitinib in the indication and InnoCare assessing soficitinib in a phase 2/3 study. Researchers are testing Bristol Myers Squibb’s Sotyktu in the indication in a midphase investigator-initiated study. Thursday, InnoCare furthered its pursuit of the market by publishing topline data from the phase 2 part of its trial. Run from sites in China, the study evaluated the effect of 24 weeks of daily oral dosing on the Facial Vitiligo Area Scoring Index (F-VASI), a measure of disease severity. At Week 24, F-VASI changed by 41.2% on the high dose of soficitinib, compared to 38.8% on the low dose and 2.2% on placebo. Both soficitinib doses performed significantly better than placebo, achieving the trial’s primary endpoint. InnoCare has yet to share further efficacy data, and only provided a high-level overview of its safety and tolerability results. The safety profile was favorable and consistent with previous studies, the company said. Soficitinib was reportedly well tolerated and no new safety signals were uncovered. InnoCare plans to share detailed safety and efficacy results at a scientific congress or in an academic journal. The phase 2/3 vitiligo study is part of a multi-front push to explore the potential of soficitinib, also called ICP-332. InnoCare is running mid- to late-phase trials in atopic dermatitis, chronic spontaneous urticaria, plaque psoriasis and prurigo nodularis. In parallel, the biotech is testing another TYK2 drug candidate, ICP-488, in a phase 2 cutaneous lupus erythematosus trial and a phase 3 plaque psoriasis study. Soficitinib is a TYK2 JH1 inhibitor, while ICP-488 binds the JH2 domain. Meanwhile, BMS’ Sotyktu and Takeda’s zasocitinib bind JH2.

100 Deals associated with Soficitinib

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Urticaria	Phase 3	China	Beijing InnoCare Pharma Tech Co., Ltd.	13 Feb 2026
Nonsegmental vitiligo	Phase 3	China	Beijing InnoCare Pharma Tech Co., Ltd.	09 May 2025
Dermatitis, Atopic	Phase 3	China	Beijing InnoCare Pharma Tech Co., Ltd.	14 Nov 2024
Moderate Atopic Dermatitis	Phase 3	China	Guangzhou InnoCare Pharma Tech Co., Ltd.	29 Sep 2024
Severe Atopic Dermatitis	Phase 3	China	Guangzhou InnoCare Pharma Tech Co., Ltd.	29 Sep 2024
Plaque psoriasis	Phase 2	China	Beijing InnoCare Pharma Tech Co., Ltd.	22 Dec 2025
prurigo nodularis	Phase 2	United States	Beijing InnoCare Pharma Tech Co., Ltd.	27 Nov 2025
prurigo nodularis	Phase 2	China	Beijing InnoCare Pharma Tech Co., Ltd.	27 Nov 2025
prurigo nodularis	Phase 2	Germany	Beijing InnoCare Pharma Tech Co., Ltd.	27 Nov 2025
prurigo nodularis	Phase 2	Poland	Beijing InnoCare Pharma Tech Co., Ltd.	27 Nov 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05702268 (Pubmed \| JAMA Dermatol) Manual	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	74	ICP-332 80 mg	thfycnoqne(aczaerpfry) = fbwjaqxssg ockrevwyky (hdgmiivnnl ) View more	Positive	14 Jan 2026
				ICP-332 120 mg	thfycnoqne(aczaerpfry) = bogumvnwtw ockrevwyky (hdgmiivnnl ) View more
NCT05702268 (Corporate Publications) Manual	Phase 2	Severe Atopic Dermatitis	75	ICP-332 80毫克组	jfkgiufeku(eyzcqkrdsc) = hfqnwasjfy xopkxfclpd (pkybxlhjrt ) Met View more	Positive	11 Mar 2024
				ICP-332 120毫克组	jfkgiufeku(eyzcqkrdsc) = ilypkfvtuj xopkxfclpd (pkybxlhjrt ) Met View more
Corporate Publications Manual	Phase 2	Dermatitis, Atopic	-	ICP-332 80mg	bchmwhptcn(rqgwxxrasx) = dbvcdujsqo diirxudvef (mcgozwihim ) Met View more	Positive	17 Dec 2023
				ICP-332 120mg	bchmwhptcn(rqgwxxrasx) = hirqhjjnzy diirxudvef (mcgozwihim ) Met View more
NCT05399030 (NEWS) Manual	Phase 1	-	8	ICP-332	cyxpgjynvg(tijgyccfdt) = 安全且具有良好耐受性 nxtlbdfywp (wmscyjgqnk )	Positive	21 Aug 2022
				Placebo

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