A Phase 3 Clinical Study of QL2106 Injection | NCT07511647

Studies
A Phase 3 Clinical Study of QL2106 Injection

NCT07511647

Sponsor

Qilu Pharmaceutical Co., Ltd.

Status

Recruiting

Last Update Posted

Jun 5, 2026Actual

Enrollment

318Estimated

Phase

Phase 3

Conditions

Plaque Psoriasis

Interventions

QL2106 injection
Tremfya®

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2026Estimated

Primary Completion Date

Dec 30, 2027Estimated

Completion Date

Feb 28, 2028Estimated

First Submitted Date

Mar 30, 2026

First Submission Date that Met QC Criteria

Mar 30, 2026

First Posted Date

Apr 6, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2026

Last Update Posted Date

Jun 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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®

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

318Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QL2106 injection	Experimental		Drug: QL2106 injection
Tremfya®	Active Comparator		Drug: Tremfya®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QL2106 injection	Drug	Administer QL2106 injection by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.The recommended dose is 100 mg.	QL2106 injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients achieving PASI-75 at week 16.	PASI-75	week 16

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yu ling Shi, Doctor	Contact	021-36803000		shiyuling1973@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jining No.1 People's Hospital	Recruiting	Jining	Shandong		China

Intervention Browse Module

MeSH Terms

ID	Term
C000588857	guselkumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided