Plaque PsoriasisPhase 3NCT07511647
A Phase 3 Clinical Study of QL2106 Injection
A Phase 3 study testing QL2106 injection and Tremfya® in people with Plaque Psoriasis, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- QL2106 injection and Tremfya®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2026to 28 Feb 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel, Active-Controlled Phase 3 Clinical Study to Compare the Efficacy and Safety of QL2106 Injection to Tremfya® in Patients With Moderate to Severe Plaque Psoriasis
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®
- Conditions
- Plaque Psoriasis
- Being tested
- QL2106 injection, Tremfya®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL2106 injectionDrug
Administer QL2106 injection by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.The recommended dose is 100 mg.
Tremfya®Drug
Administer Tremfya® by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.The recommended dose is 100 mg.
| Study group | Role | What they receive |
|---|---|---|
| QL2106 injection | Experimental | Not described Receives: Drug: QL2106 injection |
| Tremfya® | Active comparator | Not described Receives: Drug: Tremfya® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving PASI-75 at week 16.
PASI-75
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start27 May 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511647
- Sponsor's protocol ID
- QL2106-301
- Status last verified
- Oct 2026
- First submitted
- 30 Mar 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No