Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus study: Anifrolumab
Official title Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
ClinicalTrials.gov ID: NCT07691970
What this study is testing
What is Anifrolumab?
An investigational once‑weekly injectable medicine being studied for systemic lupus erythematosus and related conditions. is designed to block the type I interferon receptor, reducing inflammation.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study checks how safe it is to keep taking anifrolumab after finishing a previous trial and still feeling better.
- Who it's for
- People who finished a previous anifrolumab study, had at least one dose, and the doctor says they are still benefiting.
- What's involved
- You will keep getting the same anifrolumab treatment and have regular safety visits and tests to watch for side effects.
- Time commitment
- The study lasts until 12 weeks after your last dose, with visits scheduled during that time.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 80
You may be able to join if
- Participants are eligible to be included in the study only if all of the following criteria apply: 1 Participants must have completed the entirety of...
- In the opinion of the Investigator, the potential benefit to the participant of continuing anifrolumab at the end of the parent study outweighs the...
- Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in...
- Capable of giving signed informed consent described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF...
- Capable of adhering to the treatment plan related to this ROSY-S study.
You likely can't join if
- Participant develops hypersensitivity to any of the components of anifrolumab.
- Female participant who is breastfeeding, pregnant, or intends to become pregnant during participation in this study.
- Currently participating in any investigational study or participated in an investigational study within 30 days prior to enrolment or within 5...
- Ongoing, unresolved AE requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or...
- Currently receiving or have received prohibited medication(s) as specified in parent protocols prior to signing ICF.
- Participants who are planning to use live/live-attenuated vaccines.
See the full eligibility criteria
- Participants are eligible to be included in the study only if all of the following criteria apply: 1 Participants must have completed the entirety of the parent study and should have received at least one dose of...
- In the opinion of the Investigator, the potential benefit to the participant of continuing anifrolumab at the end of the parent study outweighs the risk.
- Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Capable of adhering to the treatment plan related to this ROSY-S study.
- Participant develops hypersensitivity to any of the components of anifrolumab.
- Female participant who is breastfeeding, pregnant, or intends to become pregnant during participation in this study.
- Currently participating in any investigational study or participated in an investigational study within 30 days prior to enrolment or within 5 half-lives of the investigational medicinal product (other than the parent...
- Ongoing, unresolved AE requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or closed) that in the Investigator's opinion would prevent restarting...
- Currently receiving or have received prohibited medication(s) as specified in parent protocols prior to signing ICF.
- Participants who are planning to use live/live-attenuated vaccines.
- Participants who are planning to use any other therapies, including B-cell therapies, that in the opinion of the Investigator could jeopardize or would compromise the participant's ability to participate in the program...
- Participants with any medical condition (such as cancer or viral infections [hepatitis]) or psychiatric condition that, in the opinion of the Investigator, could jeopardise or would compromise the participant's ability...
- Participants who discontinued the parent study prior to completion of all study visits.
- Local access to approved and commercially available (reimbursed) drug for the defined indication as permitted by local/country regulation.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Boca Raton, Florida, United States
- Fort Lauderdale, Florida, United States
- Charlotte, North Carolina, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Boca Raton, Florida, United States; Fort Lauderdale, Florida, United States; Charlotte, North Carolina, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.