Evaluate the Safety and Efficacy of Subcutaneous Siplizumab in the Treatment of Hidradenitis Suppurativa.

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06326476
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Siplizumab — DRUG
    40 mg doses

Study Details

This study is to investigate the efficacy of siplizumab in the treatment of Hidradenitis Suppurativa.

Key Dates

Start date
May 9, 2025
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: siplizumab 10mg
    Up to 6 participants may receive a 10 mg subcutaneous dose of siplizumab from week 0 to week 4 then at weeks 6 and 8.
  • Experimental: siplizumab 20mg
    Up to 6 participants may receive a 20 mg subcutaneous dose of siplizumab from week 0 to week 4 then at weeks 6 and 8.
  • Experimental: siplizumab 40mg
    Up to 6 participants may receive a 40 mg subcutaneous dose of siplizumab from week 0 to week 4 then at weeks 6 and 8.

Primary Outcome Measure

Change in inflammatory lesion counts [ Time Frame: Weeks 4, 8 and 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Ralee' B Bunt, MSPH
[email protected]
205-975-1034
Tiffany Mayo, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
University of Alabama at Birmingham· Birmingham, AL

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