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Iptacopan + standard of care (part 2) for Lupus Nephritis

Novartis Investigative Site, Carnaxide - Linda-A-Velha, Portugal
Lupus NephritisIptacopan (part 1) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it is effective, safe, and well tolerated when used in addition to standard care for treating patients.

Eligible Conditions
  • Lupus Nephritis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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1
Anifrolumab
1
zetomipzomib + standard-of care (glucocorticoids) open-label extension period
1
Daxdilimab Arm 1

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Weeks 24 and 52

Baseline and week 24
Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares
Baseline week 24
Log-transformed ratio to baseline of 24h UPCR at week 24
Week 52
Proportion of patients achieving ≥25% UPCR reduction in the absence of renal flares compared to baseline at week 24
Week 52
Parts 1 and 2: Proportion of patients achieving CRR or PRR in the absence of renal flares
Week 52
Time-to-Complete Renal Response (CRR) based on first morning void(FMV) urine samples
Weeks 24 and 52
Change from baseline FACIT-Fatigue Score
Change from baseline in BILAG-2004 score at weeks 24 and 52
Change from baseline in SLEDAI-2K score at weeks 24 and 52

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Anifrolumab
2
zetomipzomib + standard-of care (glucocorticoids) open-label extension period
2
Daxdilimab Arm 1

Trial Design

5 Treatment Groups

Iptacopan + standard of care (part 2)
1 of 5
Iptacopan + placebo (part 2)
1 of 5
Iptacopan + standard of care (part 1)
1 of 5
Placebo matching iptacopan + standard of care (part 2)
1 of 5
Placebo matching iptacopan + standard of care (part 1)
1 of 5

Active Control

Non-Treatment Group

240 Total Participants · 5 Treatment Groups

Primary Treatment: Iptacopan + standard of care (part 2) · Has Placebo Group · Phase 2

Iptacopan + standard of care (part 2)
Drug
ActiveComparator Group · 1 Intervention: Iptacopan (part 2) · Intervention Types: Drug
Iptacopan + placebo (part 2)
Drug
ActiveComparator Group · 1 Intervention: Iptacopan + placebo · Intervention Types: Drug
Placebo matching iptacopan + standard of care (part 1)
Drug
PlaceboComparator Group · 1 Intervention: Placebo + standard of care · Intervention Types: Drug
Iptacopan + standard of care (part 1)
Drug
ActiveComparator Group · 1 Intervention: Iptacopan (part 1) · Intervention Types: Drug
Placebo matching iptacopan + standard of care (part 2)
Drug
ActiveComparator Group · 1 Intervention: Placebo + standard of care · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 24 and 52

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,771 Previous Clinical Trials
3,829,994 Total Patients Enrolled
7 Trials studying Lupus Nephritis
1,334 Patients Enrolled for Lupus Nephritis

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received vaccinations for meningitis and pneumonia.
You have received a vaccine for Haemophilus influenzae.
References

Frequently Asked Questions

To what degree can combining Iptacopan and the established treatment protocol be detrimental to a patient's health?

"Our assessment of Iptacopan + standard of care (part 2) yielded a score of 2; this is because there are no known efficacy data, but safety has been partially verified." - Anonymous Online Contributor

Unverified Answer

Is there currently an enrollment period for this investigation?

"Confirmed. Medical data available on clinicaltrials.gov states that this trial is still open for participants and was first posted to the site on August 10th 2022, with its latest edit occuring on November 18th 2022." - Anonymous Online Contributor

Unverified Answer

What is the aggregate number of individuals participating in this scientific investigation?

"Affirmative. Data from clinicaltrials.gov confirms that this trial, whose first posting was on August 10th 2022 is actively recruiting for participants. A total of 240 patients need to be enrolled at 2 distinct medical centres." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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