NCT07511647

Brief Summary

It is a multicenter randomized, double-blinded, parallel, positive-controlled, Phase 3 comparative study to evaluate the efficacy and safety of QL2106 injection to Tremfya® in Patients with Moderate to Severe Plaque Psoriasis. A total of 318 subjects are planned to be included and randomized at a ratio of 1:1 to receive QL2106 injection orTremfya®

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P50-P75 for phase_3

Timeline
19mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Feb 2028

First Submitted

Initial submission to the registry

March 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

June 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

March 30, 2026

Last Update Submit

June 3, 2026

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients achieving PASI-75 at week 16.

    PASI-75

    week 16

Study Arms (2)

QL2106 injection

EXPERIMENTAL
Drug: QL2106 injection

Tremfya®

ACTIVE COMPARATOR
Drug: Tremfya®

Interventions

QL2106 injectionDRUG

Administer QL2106 injection by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.The recommended dose is 100 mg.

QL2106 injection
Tremfya®DRUG

Administer Tremfya® by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.The recommended dose is 100 mg.

Tremfya®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), prior to the first administration of study intervention
  • Total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline
  • Total psoriasis area and severity index (PASI) \>=12 at screening and baseline
  • Total investigator global assessment (IGA) \>=3 at screening and baseline
  • Candidate for phototherapy or systemic treatment for plaque psoriasis

You may not qualify if:

  • Nonplaque form of psoriasis (for example \[e.g.\], erythrodermic, guttate, or pustular)
  • Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jining No.1 People's Hospital

Jining, Shandong, China

RECRUITING

MeSH Terms

Interventions

guselkumab

Central Study Contacts

Yu ling Shi, Doctor

CONTACT

021-36803000shiyuling1973@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 6, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

February 28, 2028

Last Updated

June 5, 2026

Record last verified: 2026-03

Locations

CN(1)