CLF065 for Chronic Pouchitis

Part of paid clinical trials in La Jolla, California.

Sponsor
Calibr, a division of Scripps Research
Study ID
NCT07226050
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Pouchitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • CLF065 — DRUG
    will receive investigational product every week for 13 weeks as a sub-cutaneous injection
  • Placebo — DRUG
    CLF065 matching placebo

Study Details

This clinical trial is to evaluate investigational compound CLF065 as a treatment for adult patients with chronic pouchitis. The goals are to establish the safety, feasibility and efficacy of weekly dosing of long acting CLF065 versus placebo.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: CLF065
    CLF065 subcutaneous weekly
  • Placebo Comparator: Placebo
    Matching placebo subcutaneous weekly

Primary Outcome Measure

Change from baseline in Pouchitis Disease Activity Index (PDAI) and Modified PDAI [ Time Frame: Baseline, Week 14, Week 24 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Scripps HealthLa JollaCalifornia92037
G Konijeti, M.D
[email protected]
Phillip Fleshner, M.D. IncLos AngelesCalifornia90048
Gayane Ovsepyan
[email protected]
310 289 9224
Lenox Hill HospitalNew YorkNew York10075
A Swaminath, M.D
[email protected]
(516) 881-7067

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Scripps Health· La Jolla, CAPhillip Fleshner, M.D. Inc· Los Angeles, CALenox Hill Hospital· New York, NY

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