ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
Oruka Therapeutics, Inc.
Study ID
NCT07783542
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • ORKA-002 — DRUG
    ORKA-002 administered by subcutaneous (SC) injection
  • Placebo — OTHER
    Placebo administered by subcutaneous (SC) injection

Study Details

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

Key Dates

First listed
Aug 24, 2026
Start date
Aug 20, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Induction Period - Arm 1 (ORKA-002)
    Participants will receive ORKA-002 per protocol Induction regimen.
  • Experimental: Induction Period - Arm 2 (Placebo)
    Participants will receive Placebo per protocol Induction regimen.

Primary Outcome Measure

Proportion of participants achieving HiSCR75 at Week 16 [ Time Frame: Week 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oruka Therapeutics Investigative Site, Chapel Hill, NC 27516Chapel HillNorth Carolina27516
Oruka Investigative Site
[email protected]
781-560-0299

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By research site
Oruka Therapeutics Investigative Site, Chapel Hill, NC 27516· Chapel Hill, NC

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