An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
ConditionPlaque Psoriasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOruka Therapeutics, Inc.
About this trial
An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent by participants from previous trial choosing to transition into the OLE.
Participants who have successfully completed the preceding trial.
For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.
For women of childbearing potential and fertile male participants with a partner of childbearing potential must be willing to continue to use highly effective contraception
Disqualifiers
Participants who experienced any adverse events with ORKA-001 in the preceding trial that led to permanent investigational medicinal product discontinuation or, in the opinion of the Investigator, would preclude continued treatment with ORKA-001
Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.
Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding during the medical examination that, in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.
Any clinically significant laboratory abnormality based on the last available lab results received during the preceding trial, that, according to the Investigator's medical assessment, precludes them from continued treatment with ORKA-001.
Trial design
Design model
Parallel
Treatments tested in this trial
ORKA-001
DrugORKA-001 administered by subcutaneous (SC) injection
Treatment groups
240 Participants
are divided into 4 treatment groupsGroup A: ORKA-001 Once Yearly (High Dose)Experimental treatment 1 intervention
Group B: ORKA-001 Once Yearly (Low Dose)Experimental treatment 1 intervention
Group C: ORKA-001 Twice YearlyExperimental treatment 1 intervention
Group D: No DrugNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs)
Incidence of treatment adverse events, treatment-emergent serious adverse events, treatment adverse events of special interest, and potential clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms.
Time frame
Day 1 through Week 144Secondary outcomes
1
Proportion of Participants Maintaining PASI100 in the Subset of Participants Meeting the Criterion at Baseline of OLE
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
Day 1 through Week 962
Proportion of Participants Maintaining PASI90 in the Subset of Participants Meeting the Criterion at Baseline of OLE
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
Day 1 through Week 963
Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0 in the Subset of Participants Meeting the Criterion at Baseline of OLE
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
Day 1 through Week 964
Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0/1 in the Subset of Participants Meeting the Criterion at Baseline of OLE
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
Time Frame: Day 1 through Week 96Sponsors and contacts
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Source ClinicalTrials.gov