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Dapirolizumab Pegol for Lupus (PHOENYCS GO Trial)

Phase 3
Waitlist Available
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
With serological evidence for SLE at Screening as demonstrated by at least 1 of the following: Evidence for anti-dsDNA, complement C3 < lower limit of normal (LLN) OR complement C4 <LLN OR elevated erythrocyte-bound complement C4d, Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies: Anti-Smith (anti-Sm) antibodies, Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies, Historic evidence for anti-dsDNA antibodies
Moderately to severely active defined as British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in ≥2 organ systems and/or a BILAG 2004 Grade A in ≥1 organ systems at Screening and Baseline Visit AND Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 at Screening Visit AND SLEDAI-2K without labs ≥4 at Baseline Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (day 1) until safety follow-up (up to week 54)
Awards & highlights

PHOENYCS GO Trial Summary

This trial will test whether the drug DZP can help improve the symptoms of people with moderate to severe disease activity, when used alongside SOC medication.

Who is the study for?
This trial is for people over 16 with moderate to severe active Systemic Lupus Erythematosus (SLE), diagnosed at least 24 weeks ago, showing specific antibodies or complement levels. They must be on stable standard treatments but still have active symptoms. Excluded are those with recent live vaccines, significant infections, advanced kidney failure, certain psychiatric conditions, a history of cancer (with exceptions), HIV, and other immune deficiencies.Check my eligibility
What is being tested?
The study tests Dapirolizumab Pegol (DZP) added to usual care medications in SLE patients. It aims to see if DZP can significantly improve long-term disease activity compared to a placebo group.See study design
What are the potential side effects?
While the side effects of Dapirolizumab Pegol aren't detailed here, similar drugs may cause injection site reactions, increased risk of infections due to immune system suppression, allergic reactions and possibly impact blood cell counts.

PHOENYCS GO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have lab results showing I might have lupus.
Select...
My lupus is active, affecting multiple organs.

PHOENYCS GO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day 1) until safety follow-up (up to week 54)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) until safety follow-up (up to week 54) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Achievement of BICLA response at Week 48
Secondary outcome measures
Achievement of BICLA response at Week 12
Achievement of BICLA response at Week 24
Achievement of BILAG improvement without worsening at Week 48
+12 more

PHOENYCS GO Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dapirolizumab pegolExperimental Treatment1 Intervention
Subjects will receive dapriolizumab pegol througout the Treatment Period.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will receive placebo througout the Treatment Period.

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
21,115 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273 (UCB)
205 Previous Clinical Trials
44,642 Total Patients Enrolled

Media Library

DZP Clinical Trial Eligibility Overview. Trial Name: NCT04294667 — Phase 3
Lupus Research Study Groups: Placebo, Dapirolizumab pegol
Lupus Clinical Trial 2023: DZP Highlights & Side Effects. Trial Name: NCT04294667 — Phase 3
DZP 2023 Treatment Timeline for Medical Study. Trial Name: NCT04294667 — Phase 3

Frequently Asked Questions

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

What other experiments have there been with DZP?

"At present, there are two clinical trials being conducted to study the efficacy of diazepam. Two of those trials are in Phase III. While many of the studies for diazepam are based in Kwei-san Hsiang, Kentucky, there are 345 locations across the globe running clinical trials for this treatment."

Answered by AI

Could you please elaborate on the safety concerns of DZP?

"DZP safety is estimated to be a 3."

Answered by AI

Are there different instances of this research project happening in different states?

"Right now, this research is enrolling patients at 81 different sites. A few examples of these locations are Trois-Rivières, New york and Syracuse. If you are considering participating in this study, it is best to choose a site that is close to you in order to limit travel."

Answered by AI

How many people are enrolled in this program?

"In order to properly test the efficacy of the proposed treatment, 450 individuals who match the pre-determined inclusion criteria must participate. These patients can be recruited from various locations, including Sl00043 50044 in Trois-Rivières, New york and Sl0043 50334 in New York, California."

Answered by AI

Has this type of treatment been done before?

"DZP has a long clinical history, with the first trial being sponsored by UCB Biopharma SRL in 2020. After the first Phase 3 trial, which had a sample size of 450 people, DZP was approved as a drug. As of now, there are 2 active global trials for DZP being conducted in 70 different cities and 27 countries."

Answered by AI

Are patients being actively recruited for this clinical trial at this time?

"That is accurate. The information available on clinicaltrials.gov affirms that this study, which was initially posted on 2020-08-12, is still recruiting patients. The goal is to enroll 450 individuals from 81 different hospitals or clinics."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Sl0043 50036
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
2020. "A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04294667.
All > Systemic Lupus Erythematosus > Lupus
~33 spots leftby Sep 2024
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