200 Participants NeededMy employer runs this trial

ORKA-002 for Hidradenitis Suppurativa

Recruiting at 2 trial locations
OC
Overseen ByOruka Clinical Trials Information
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Oruka Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a multicenter, randomized, double-blinded, placebo-controlled clinical study of ORKA-002 in adult participants with moderate-to-severe HS.

Are You a Good Fit for This Trial?

This trial is for adults with moderate-to-severe hidradenitis suppurativa (HS) who have had symptoms for at least 6 months, HS in two or more body areas (with one being advanced), and haven't improved with antibiotics or can't take them. People with other active skin diseases or autoimmune conditions can't join.

Inclusion Criteria

I have had symptoms of HS for at least 6 months.
I have HS lesions in at least two body areas, with one area at Hurley Stage II or III.
I have HS and antibiotics have not worked, caused problems, or I cannot take them.

Exclusion Criteria

I do not have any other active skin diseases that could affect my HS assessment.
I have been diagnosed with an autoimmune or inflammatory disease other than HS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Period

Participants receive ORKA-002 or placebo every 4 weeks for 12 weeks during a double-blind induction period

12 weeks
3 visits (in-person)

Maintenance Period

Participants receive ORKA-002 every 12 weeks during an open-label maintenance period

76 weeks
6 visits (in-person)

Post-Treatment Follow-Up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ORKA-002

Trial Overview

The study compares a new drug called ORKA-002 to a placebo (inactive treatment) in people with moderate-to-severe HS. Participants are randomly assigned to receive either the real drug or placebo without knowing which they get.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Induction Period - Arm 2 (Placebo)Experimental Treatment1 Intervention
Group II: Induction Period - Arm 1 (ORKA-002)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oruka Therapeutics, Inc.

Lead Sponsor

Trials
1
Recruited
20+