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Monoclonal Antibodies

CUG252 for Lupus

Verified Trial
Phase 1
Recruiting
Research Sponsored by Cugene Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female participant, aged 18 to 65 years (inclusive), at time of consent
If a participant is taking azathioprine, antimalarial, mycophenolate mofetil, or methotrexate, the medication(s) must have been started a minimum of 12 weeks prior to Screening and at a stable dose for a minimum of 8 weeks prior to Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 pre dose through day 64
Awards & highlights

Study Summary

This trial tests a new drug for people with lupus to see if it's safe and effective.

Who is the study for?
This trial is for adults aged 18-65 with mild-to-moderate Systemic Lupus Erythematosus (SLE). Participants must have been diagnosed at least 6 months prior and have a stable medication regimen if they're taking prednisone or other specific SLE treatments. They should also meet certain body weight criteria.Check my eligibility
What is being tested?
The study tests the safety of multiple doses of a new drug, CUG252, compared to a placebo in people with SLE. The goal is to see how well participants tolerate this potential new treatment for lupus symptoms.See study design
What are the potential side effects?
While the side effects are being studied, common issues may include reactions at the injection site, flu-like symptoms, headaches, or gastrointestinal discomfort. Since it's an immune-related treatment, there might be risks of altering immune function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been on stable doses of specific medications for at least 8 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 pre dose through day 64
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 pre dose through day 64 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number and percentage of subjects with Treatment Emergent Adverse Events
Secondary outcome measures
Change in the number and percentages of immune cells
Immunogenicity of CUG252
Pharmacokinetics profile of CUG252 (AUC)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CUG252Experimental Treatment1 Intervention
CUG252 or placebo will be administered to participants in a 3:1 ratio.
Group II: PlaceboPlacebo Group1 Intervention
CUG252 or placebo will be administered to participants in a 3:1 ratio.

Find a Location

Who is running the clinical trial?

Cugene Inc.Lead Sponsor
1 Previous Clinical Trials
32 Total Patients Enrolled

Media Library

CUG252 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05866861 — Phase 1
Lupus Research Study Groups: CUG252, Placebo
Lupus Clinical Trial 2023: CUG252 Highlights & Side Effects. Trial Name: NCT05866861 — Phase 1
CUG252 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05866861 — Phase 1
Lupus Patient Testimony for trial: Trial Name: NCT05866861 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential adverse effects of utilizing CUG252?

"The safety of CUG252 was rated with a score of 1 based on the limited evidence available for its efficacy and safety since this is an early phase trial."

Answered by AI

Is it possible to join the current clinical trial?

"To take part in this medical trial, participants must be diagnosed with lupus and between 18-65 years old. Currently, the team is looking for 40 people to join them."

Answered by AI

Is the age requirement for enrollment in this trial restricted to adults?

"Based on the outlined criteria, only individuals between 18 and 65 years old will be qualified to participate in this medical trial. An additional 22 clinical trials are available for people younger than 18 and 125 studies are accessible by those above 65."

Answered by AI

Could you provide information on the current enrollment process of this clinical trial?

"The available information on clinicaltrials.gov suggests that the medical trial is still recruiting participants, having been first posted online in April of 2023 and last updated in May of the same year."

Answered by AI

To what extent is this trial being conducted across various sites?

"Patients are welcome to join this trial at Site 1011 in La Jolla, California; Site 1002 in Clearwater, Florida; and Site 1009 in Tampa, Georgia. Additionally, there are 11 other locations for potential enrolment."

Answered by AI

How many individuals have been enrolled in this investigation thus far?

"Affirmative. According to clinicaltrials.gov, the trial is still recruiting participants since it was first posted on April 24th 2023 and most recently upgraded on May 10th of this year. The study seeks 40 individuals that can be found at 11 various sites across America."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Site 1007
Site 1006
Site 1004
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Interested in all lupus and autoimmune clinical trials to help myself and others.
PatientReceived 1 prior treatment
I want to get those skin disorder under control without the heavy meds like mtx and prednisone.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus
2023. "A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05866861.
All > Systemic Lupus Erythematosus > Lupus
~6 spots leftby Jul 2024
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