Brief Summary

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

160

participants targeted

Target at P75+ for phase_2

Timeline

31mo left

Started Dec 2025

Typical duration for phase_2

Geographic Reach

2 countries

26 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

Study Progress14%

Dec 2025Dec 2028

Study Start

First participant enrolled

December 3, 2025

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2025

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

December 16, 2025

Last Update Submit

March 26, 2026

Conditions

Plaque Psoriasis

Keywords

Phase 2ORKA-001Plaque psoriasis

Outcome Measures

Primary Outcomes (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).
Week 16

Secondary Outcomes (9)

Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16
Week 16
Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16
Week 16
Proportion of Participants Who Achieve an IGA = 0 (Clear) or 1 (Almost Clear) at Week 16
Week 16
Proportion of Participants Maintaining 100% Reduction in PASI Score at Week 100
Week 100
Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 100
Week 100
+4 more secondary outcomes

Study Arms (7)

(Induction Period - Arm 1) ORKA-001

EXPERIMENTAL

Participants will receive 37.5 mg ORKA-001 per protocol Induction regimen.

Drug: ORKA-001

(Induction Period - Arm 2) ORKA-001

EXPERIMENTAL

Participants will receive 300 mg ORKA-001 per protocol Induction regimen.

Drug: ORKA-001

(Induction Period - Arm 3) ORKA-001

EXPERIMENTAL

Participants will receive 600 mg ORKA-001 per protocol Induction regimen.

Drug: ORKA-001

(Induction Period - Arm 4) Placebo

PLACEBO COMPARATOR

Participants will receive Placebo per protocol Induction regimen.

Other: Placebo

(Maintenance Period - Arm 1) ORKA-001

EXPERIMENTAL

Participants will receive 300 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.

Drug: ORKA-001

(Maintenance Period - Arm 2) ORKA-001

EXPERIMENTAL

Participants will receive 600 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.

Drug: ORKA-001

(Maintenance Period - Arm 3) Placebo

PLACEBO COMPARATOR

Participants will receive Placebo per protocol Maintenance regimen, based on protocol defined response.

Other: Placebo

Interventions

ORKA-001DRUG

ORKA-001 administered by subcutaneous (SC) injection

(Induction Period - Arm 1) ORKA-001(Induction Period - Arm 2) ORKA-001(Induction Period - Arm 3) ORKA-001(Maintenance Period - Arm 1) ORKA-001(Maintenance Period - Arm 2) ORKA-001

PlaceboOTHER

Placebo administered by subcutaneous (SC) injection

(Induction Period - Arm 4) Placebo(Maintenance Period - Arm 3) Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants ≥ 18 years of age
Have a diagnosis of plaque psoriasis for \> 6 months
Have moderate-to-severe chronic plaque psoriasis defined as:
BSA ≥ 10%, and
PASI ≥ 12, and
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 may not qualify 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

Contact the study team to confirm eligibility.