Trial Registered

Hengrui advances third SHR-1139 psoriasis trial as PASI 100 bar

The Phase 2 study sets a full-clearance PASI 100 threshold at week 12, a higher bar than the PASI 75/90 endpoints common in the crowded psoriasis field.

Guangdong Hengrui Pharmaceutical registered a Phase 2 trial of SHR-1139 in moderate-to-severe plaque psoriasis, its third clinical study of the asset.

By AppliedXLJuly 22, 2026Trial NCT07719530

Executive Summary

Guangdong Hengrui Pharmaceutical registered a Phase 2 trial testing SHR-1139 against placebo in moderate-to-severe plaque psoriasis, with a primary endpoint that requires complete skin clearance rather than the partial-response thresholds common in the field.
This is the sponsor's third clinical study of SHR-1139 in psoriasis, coming after a completed Phase 1 study and while a separate Phase 2 placebo-controlled trial of the same drug remains active, showing a sponsor advancing the asset on parallel tracks rather than starting from a single dataset.
The psoriasis field is mature and mechanism-diverse, with IL-17, IL-23, TNF and TYK2 inhibitors already approved and in late-stage development, so a new entrant is measured against an established efficacy bar rather than an open unmet need.
The molecular target behind SHR-1139 is not established in the trial record, which limits how precisely its competitive position within any single mechanism class can be judged.

The new trial

The study, listed under NCT07719530, will enroll an anticipated 60 patients with moderate-to-severe plaque psoriasis in China, randomized across two arms under quadruple masking, meaning patients, investigators, outcome assessors and data analysts are all blinded to treatment assignment. It has not yet started recruiting, with a planned start date of August 1, 2026, and a primary completion date of December 31, 2026. The primary endpoint is the proportion of patients achieving PASI 100, a 100% improvement in the Psoriasis Area and Severity Index score from baseline, at week 12. Secondary endpoints include the more commonly used PASI 75 and PASI 90 thresholds and static Physician's Global Assessment scores of 0 or 0/1, also measured at week 12. NCT07719530

A drug already in testing

SHR-1139 is not a first attempt for Hengrui in this disease. A completed Phase 1 trial tested single subcutaneous or intravenous doses in healthy Chinese subjects and multiple subcutaneous doses in patients with moderate-to-severe plaque psoriasis, enrolling 64 participants. A second, still-active Phase 2 trial is comparing SHR-1139 against placebo in the same population, with 145 patients enrolled and a primary completion date of November 1, 2025. The new trial runs alongside that program rather than replacing it, giving Hengrui two concurrent placebo-controlled readouts on the same molecule in the same indication.

The endpoint bar

Setting PASI 100, not PASI 75 or PASI 90, as the primary measure raises the bar relative to how most approved psoriasis therapies define success in their own labels. Registered analogs in the same indication family show what that competitive backdrop looks like: AbbVie's risankizumab and Bausch Health's brodalumab both remain in active testing at Phase 3 and Phase 4 respectively, alongside earlier-generation options such as adalimumab in a Chinese Phase 4 trial from Chia Tai Tianqing Pharmaceutical Group. None of these share SHR-1139's mechanism on the record, since the trial does not disclose the drug's molecular target, but they define the efficacy standard a new entrant in plaque psoriasis has to clear.

Sponsor track record

Hengrui has completed 20 of 21 prior trials tracked across its portfolio, with one termination, and the psoriasis program specifically has a 100% completion rate across its two prior trials. Across its full pipeline the company runs 54 trials spanning completed, recruiting, active and not-yet-recruiting stages. The registry-churn signal on this specific trial is flat, with no protocol amendments logged since registration. NCT07719530

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.