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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Oruka Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

8 May 2026 → ongoing

Decision date (initial)

2026-05-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Oruka Therapeutics, Inc.

External identifiers

EU CT number

2025-523797-17-00

ClinicalTrials.gov

NCT07290569

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety

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

Secondary objectives 4

1. To evaluate the efficacy of 2 dose regimens of ORKA-001 in the Maintenance Period in participants with moderate-to-severe plaque psoriasis who achieved PASI100 at Week 28
2. To evaluate the effect of each ORKA-001 induction dosing regimen on quality of life compared to placebo at Week 16 in participants with moderate-to-severe plaque psoriasis
3. To evaluate the safety and tolerability of 3 dose regimens of ORKA-001 in the Maintenance Period in participants with moderate-to-severe plaque psoriasis
4. To characterize the pharmacokinetics (PK) of 3 induction dose regimens and 2 maintenance dose regimens of ORKA-001 in participants with moderate-to-severe plaque psoriasis

Conditions and MedDRA coding

Moderate-to-Severe Plaque Psoriasis

Study design 4 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participants ≥ 18 years of age
2. Have a diagnosis of plaque psoriasis for > 6 months
3. 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
4. Candidate for systemic therapy or phototherapy
5. Women of childbearing potential must have a negative pregnancy test

Exclusion criteria 5

1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
2. 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
3. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
4. A known hypersensitivity to any components of the ORKA-001 drug product
5. Women who are breastfeeding or plan to breastfeed during the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16: The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease) (Time Frame: Week 16)

Secondary endpoints 9

1. Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16: The Investigator Global Assessment (IGA) documents the Investigator’s assessment of the participant’s psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant’s psoriasis is assessed as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). (Time Frame: Week 16)
2. Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16 (Time Frame: Week 16)
3. Proportion of Participants Who Achieve an IGA = 0 (Clear) or 1 (Almost Clear) at Week 16 (Time Frame: Week 16)
4. Proportion of Participants Maintaining 100% Reduction in PASI Score at Week 100 (Time Frame: Week 100)
5. Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 100 (Time Frame: Week 100)
6. Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 100 (Time Frame: Week 100)
7. Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 100 (Time Frame: Week 100)
8. Proportion of Participants Maintaining 75% Reduction in PASI Score at Week 100 (Time Frame: Week 100)
9. Incidence of Treatment-emergent Adverse Events (TEAEs) and TEAEs of Special Interest (TEAESIs): Incidence of treatment adverse events, treatment adverse events of special interest, and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms. (Time Frame: Day 1 through Week 100)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oruka Therapeutics Inc.

Sponsor organisation

Oruka Therapeutics Inc.

Address

855 Oak Grove Avenue Suite 100

City

Menlo Park

Postcode

94025-4429

Country

United States

Scientific contact point

Organisation

Oruka Therapeutics Inc.

Contact name

Research Medical Director

Public contact point

Organisation

Oruka Therapeutics Inc.

Contact name

Research Medical Director

Third parties 10

Locations

2 EU/EEA countries · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 24 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications