A Phase 3 Clinical Study of QL2106 Injection
Recruiting
Phase 3
Interventional Study
Plaque Psoriasis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 318 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
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About This Trial
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 Locations
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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 (P…
Contacts