Authorised Therapeutic exploratory (Phase II) Moderate-to-Severe Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients with Moderate-to-Severe Plaque Psoriasis (EVERLAST-B)

EU CTIS ID: 2025-523797-17-00

What this study is testing

To evaluate the efficacy of ORKA-001 compared to placebo and select the induction dose regimen of ORKA-001 with the optimal benefit-risk profile in participants with moderate-to-severe plaque psoriasis

  • Therapeutic exploratory (Phase II)

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

Who can take part

You may be able to join if

  • Participants ≥ 18 years of age
  • Have a diagnosis of plaque psoriasis for > 6 months
  • Have moderate-to-severe chronic plaque psoriasis defined as: a. BSA ≥ 10%, and b. PASI ≥ 12, and c. IGA score of ≥ 3 on a 5-point scale
  • Candidate for systemic therapy or phototherapy
  • Women of childbearing potential must have a negative pregnancy test

You likely can't join if

  • Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
  • Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, or any infectious disease
  • History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
  • A known hypersensitivity to any components of the ORKA-001 drug product
  • Women who are breastfeeding or plan to breastfeed during the study

The study team makes the final eligibility decision.

Where it's taking place

  • United States
  • Canada

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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; Canada. 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 EU CTIS; the study team decides eligibility.