A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosus.

Phase 3

• Conditions: M320 Drug-induced systemic lupus erythematosus; Drug-induced systemic lupus erythematosus; M320

• Registration Number: PER-022-22
• Lead Sponsor: CB Biopharma SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-14
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: In enrollment
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Type of participant and disease characteristics
1.The participant could, in the opinion of the Investigator, benefit from long-term DZP treatment.

2.The participant completed one of the following PBO-controlled parent studies (SL0043 and SL0044) (ie, were not prematurely withdrawn from the parent studies) within 4 weeks prior to entry to this study.

Weight
3.Participants with body weight >40kg at the Baseline for this study.

Sex
4.Male and/or female
A male participant must agree to use contraception, as detailed in Appendix 4 (Section 10.4) of this protocol, during the Treatment Period and for at least 17 weeks, after the last dose of DZP, and refrain from donating sperm during this period.
A female participant is eligible to participate if at least one of the following conditions applies:
Not a woman of childbearing potential (WOCBP)
OR
A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 (Section 10.4) during the Treatment Period and for at least 17 weeks after the last dose of DZP.
OR
WOCBP who is pregnant or breastfeeding and agrees to be regularly assessed during the study although she will not be dosed with DZP as long she is pregnant or breastfeeding (see Section 7.1.1)

Informed consent
5.Participant is capable of giving signed informed consent as described in Appendix 1 (Section 10.1), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria

Prior/Concomitant therapy
7. Study participant required the use of prohibited medications listed in Table 6 4, regardless of route (with the exception of eye drops), within the time frame (Wash-Out Period) listed in the table prior to Screening/Baseline (Visit 1 in SL0046).

1. Participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study. This includes study participants with a life-threatening condition (eg, CTCAE grade 4 conditions, CAPS, acute severe renal failure, acute severe central nervous system [CNS] manifestations) or ongoing malignancies at the start of the study.

2. Participant has presented in the parent study or after its completion with a medical condition or its worsening which, in the opinion of the Investigator, predisposes the participant to significant additional safety risk due to study drug treatment in this OLE study, or met the safety criteria for permanent study drug discontinuation in the parent study.

3. The participant permanently discontinued study drug during the parent study due to safety reasons.

Infection-related risks
4. Study participant has a known ongoing clinically significant active or latent infection (eg, human immunodeficiency virus, active or latent tuberculosis (TB), chronic viral hepatitis B or C, severe acute respiratory syndrome coronavirus 2 [SARS CoV 2] infection). Participants with a latent TB acquired during the parent studies can enter SL0046 if they received prophylactic tuberculostatic treatment for at least 4 weeks. Participants with a known SARS CoV 2 infection can enter the OLE study not earlier than 1 week after recovery of symptoms or 2 weeks after diagnosis of an asymptomatic SARS CoV 2 infection.

5. Study participant has received live vaccines within 6 weeks prior to the first DZP infusion (Visit 1) or who plan to receive live vaccines during the study or 12 weeks after the final dose of DZP. Use of nonlive vaccines may be allowed during the study but should be discussed with the Medical Monitor upfront, if possible.

6. Study participant has a history of chronic alcohol or drug abuse within the previous 24 weeks.

Diagnostic assessments
8. Study participant has history of a suicide attempt during the parent study, since the participant completed the parent study, or has had suicidal ideation in the past 6 months as indicated by a positive response (Yes”) to either Question 4 or Question 5 of the Screening/Baseline” version of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screen

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of TEAEs, serious TEAEs, TEAEs leading to permanent DZP discontinuation<br> NAME OF THE RESULT: To evaluate the long-term safety and tolerability of DZP treatment<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: The incidence of TEAEs, serious TEAEs, and TEAEs leading to permanent DZP discontinuation over 110 weeks will be used to demonstrate the safety of DZP long term.