Recruiting PHASE2, PHASE3 Psoriatic Arthritis

New treatment option for Psoriatic Arthritis

Official title A Study of Picankibart in Patients With Active Psoriatic Arthritis

ClinicalTrials.gov ID: NCT07295509

What this study is testing

What is Picankibart?

Picankibart is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for psoriatic arthritis.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial evaluating the efficacy and safety of picankibart (IBI112) in patients with active psoriatic arthritis (PsA). The study consists of two stages: Phase II dose-finding (n=90) and Phase III confirmatory (n=132).
  • Phase 3: a large, late-stage study
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75

You may be able to join if

  • Age 18-75 years
  • Diagnosed with PsA for ≥3 months, and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) at screening
  • Having active PsA: ≥3 tender joints and ≥3 swollen joints at screening and baseline
  • Having active plaque psoriasis (≥1 lesion ≥2cm) or nail psoriasis, or a documented history of plaque psoriasis
  • Inadequate response or intolerance to prior NSAIDs or non-biologic DMARDs

You likely can't join if

  • Other inflammatory conditions that may affect the evaluation of the study drug
  • Prior treatment with \>2 biologic agents
  • Recent use of prohibited medications (specific washout periods apply)
  • Non-plaque psoriasis forms or drug-induced psoriasis
  • Severe, progressive, or uncontrolled renal, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, rheumatic...
  • Significant laboratory abnormalities
See the full eligibility criteria
Who can join
  • Age 18-75 years
  • Diagnosed with PsA for ≥3 months, and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) at screening
  • Having active PsA: ≥3 tender joints and ≥3 swollen joints at screening and baseline
  • Having active plaque psoriasis (≥1 lesion ≥2cm) or nail psoriasis, or a documented history of plaque psoriasis
  • Inadequate response or intolerance to prior NSAIDs or non-biologic DMARDs
  • Stable doses of protocol permitted background therapy (if any)
What rules you out
  • Other inflammatory conditions that may affect the evaluation of the study drug
  • Prior treatment with \>2 biologic agents
  • Recent use of prohibited medications (specific washout periods apply)
  • Non-plaque psoriasis forms or drug-induced psoriasis
  • Severe, progressive, or uncontrolled renal, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, rheumatic (excluding PsA), psychiatric, or genitourinary conditions
  • Significant laboratory abnormalities
  • Pregnancy or breastfeeding

The study team makes the final eligibility decision.

Where it's taking place

  • Hangzhou, Zhejiang, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.