A multicenter, randomized, double-blinded, placebo-controlled phase III trial to evaluate efficacy and safety of picankibart in moderate-to-severe plaque psoriasis - 24/04/26

Doi : 10.1016/j.jaad.2026.04.001

Yunlu Gao, MD ^a, Lanying Qin, MM ^b, Yumei Li, MD ^c, Yong Cui, MD ^d, Shifa Zhang, MD ^e, Lunfei Liu, MM ^f, Lihua Wang, MM ^g, Chao Ci, BM ^h, Jianyun Lu, MD, PhD ⁱ, Rixin Chen, MM ^j, Yanyan Feng, MD ^k, Shanshan Li, MD, PhD ^l, Chenghang Cai, MM ^m, Mingxia Chen, MS ^m, Han Han-Zhang, PhD ^m, Yue Li, PhD ^m, Lei Qian, MD, PhD ^m, Yuling Shi, MD, PhD ^a,^⁎
for the
CLEAR-1 Investigators ^{^∗}
A complete list of investigators in the CLEAR-1 trial is provided in Supplemental Material 1 (available via Mendeley at 1 ).

^a Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China

^b Department of Dermatology, Cangzhou People's Hospital, Cangzhou, China

^c Department of Dermatology, Affiliated Hospital of Jiangsu University, Zhenjiang, China

^d Department of Dermatology, China-Japan Friendship Hospital, Beijing, China

^e Center for Dermatological Diagnosis and Treatment, China First Mandarin Northeast International Hospital Co., Ltd., Shenyang, China

^f Department of Dermatology, The Fourth Affiliated Hospital, Zhejiang University School of Medicine, Yiwu, China

^g Department of Dermatology, Central Hospital Affiliated to Shandong First Medical University, Jinan, China

^h Department of Dermatology, Yijishan Hospital, The First Affiliated Hospital of Wannan Medical College, Wuhu, China

ⁱ Department of Dermatology and Venereology, The Third Xiangya Hospital of Central South University, Changsha, China

^j Department of Dermatology, Nanyang First People's Hospital, Nanyang, China

^k Department of Dermatology, Chengdu Second People's Hospital, Chengdu, China

^l Department of Dermatology and Venereology, The First Hospital of Jilin University, Changchun, China

^m Innovent Biologics, Inc., Suzhou, China

^∗ Correspondence to: Professor Yuling Shi, MD, PhD, Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, No. 1278, Baode St, Jingan District, Shanghai, China. Department of Dermatology Shanghai Skin Disease Hospital Tongji University School of Medicine No. 1278 Baode St Jingan District Shanghai China

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Abstract

Background

The development of interleukin-23 inhibitors that offer sustained complete skin clearance with reduced-frequency dosing addresses a significant unmet clinical need in managing moderate-to-severe plaque psoriasis.

Objective

To evaluate the efficacy and safety of picankibart, an interleukin-23p19 inhibitor, in Chinese patients.

Methods

CLEAR-1 enrolled participants aged 18-75 years to randomly receive picankibart subcutaneously 200 mg at weeks 0/4/8/20/32/44, picankibart 200 mg at weeks 0/4/8 then 100 mg at weeks 20/32/44; or placebo at weeks 0/4/8 then picankibart 200 mg at weeks 16/20/24/32/44. The co-primary endpoints were ≥90% improvement in psoriasis area and severity index and static physician's global assessment clear/almost clear status (0/1) at week 16.

Results

In picankibart 200 mg group, 80.3% achieved ≥90% improvement in psoriasis area and severity index and 93.5% achieved static physician's global assessment 0/1 at week 16 vs 2.0% and 13.1%, respectively with placebo. All key secondary endpoints were significantly improved (all two-sided P < .0001 vs placebo). Efficacy was maintained through week 52 for both 100 mg and 200 mg doses, with no new safety signal observed.

Limitations

Chinese only; no active comparator.

Conclusion

Picankibart provided effective skin clearance in Chinese participants by week 16. A dosing regimen of every 12 weeks with either 100 mg or 200 mg maintained these clinical improvements through week 52.

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Key words : dermatology life quality index, IL-23p19 inhibitor, phase 3 clinical trial, plaque psoriasis, psoriasis area and severity index, static physician's global assessment

Abbreviations used : AE, DLQI, IL, PASI, SD, sPGA, TEAE

Plan

Participant characteristics

	Dr Gao and Author Qin contributed equally to this work.
	Funding sources: Funding was provided by the Innovent Biologics Co Ltd , Suzhou, China.
	Patient consent: Written consent form was completed by all participants in this CLEAR-1 trial.
	IRB approval status: Reviewed and approved by ethics committee of Shanghai Skin Disease Hospital; approval number 2022-25 (Drug).
	Data and code availability: Individual participant data that underline the results reported here can be made available to other qualified medical investigators after deidentification, via a request to the corresponding author and the study sponsor. The requestors for access to the data will need to sign a data access agreement following consultations between the corresponding author and the study sponsor.