Effects of TNF Blockade on Human BPH/LUTS

Part of paid clinical trials in Glenview, Illinois.

Sponsor
Endeavor Health
Study ID
NCT06062875
Phase
PHASE2
Status
Recruiting
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Conditions

  • Benign Prostatic Hyperplasia (BPH)

Eligibility Criteria

Sex
MALE
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Adalimumab will be delivered subcutaneously (under the skin) at a dose of 40mg every 2 weeks for a total of 6 doses.

Study Details

Specific Aim 1. To evaluate the efficacy of TNF antagonist action in BPH/LUTS Specific Aim 2. Define the consequences of TNF antagonist therapy on prostate tissue Specific Aim 3. Identify genetic predictors to stratify patients with differential response to TNF-antagonist therapy.

Key Dates

Start date
Jan 24, 2024
Status verified
Nov 2024
Primary completion
Apr 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: adalimumab
    adalimumab 40 mg every 2 weeks
  • No Intervention: Placebo
    placebo injection (saline) every 2 weeks.

Primary Outcome Measure

International Prostate Symptom Score [ Time Frame: The past 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NorthShore University HealthSystemGlenviewIllinois60026
Pooja Talaty, MS MHA CCRP
[email protected]
847-503-4280
Simon W Hayward, Ph.D
Alexander P Glaser, M.D.

Find similar trials in Glenview, IL

By research site
NorthShore University HealthSystem· Glenview, IL

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