What is the LOTUS Study?
The LOTUS Study will assess whether an investigational drug is safe and works in people with systemic lupus erythematosus (SLE). ‘Investigational’ means that the safety and effectiveness of the drug has not been approved by a regulatory authority for a specific clinical use, and the drug is still being studied in studies such as this one. The investigational drug will be compared with a placebo. A placebo looks exactly like the investigational drug and is given the same way but contains no active drug. Throughout this website, the term ‘study drug’ is used for both the investigational drug and placebo.
Who can take part?
About 500 participants across North & South America, Europe, Asia and South Africa are expected to take part in this study. Not everyone can join the study as several criteria must be met to participate. Your decision to leave will not affect any future medical care that you receive.
How long will the study last?
If you complete all 3 parts of the study, participation could last up to 3.5 years:
- Part 1: Screening – 6 weeks before the double-blind treatment period, you will undergo medical tests to determine whether you can take part. ‘Double-blind’ means that neither you nor the study staff knows which study drug you are taking.
- Part 2: Double-blind treatment period – if you qualify, you will visit the study clinic every 4 weeks for 52 weeks (14 visits in total), during which you will undergo further tests and receive the study drug.
- Part 3: Extension period – you may be able to join the extension period, during which you will receive the investigational drug and visit the study clinic over 104 weeks (6 visits in total).
If you remain on the study drug and complete the double-blind treatment period, but do not enter the extension period, you will be asked to return for a follow-up visit 16 weeks after the last dose of study drug to undergo study evaluations. If you complete the extension period, you will return to the study clinic for a follow-up visit 16 weeks after the last dose of the investigational drug to undergo end-of-study evaluations.
Which study drug will I receive?
Once enrolled, a computer will assign you to one of two study treatment groups:
- Study treatment group 1 will receive the investigational drug
- Study treatment group 2 will receive placebo
You will have a 3 in 5 chance of receiving the investigational drug. Neither you nor the study staff will know to which study treatment group you have been assigned. This ensures that the results from the tests and assessments are handled in the same way. Throughout the study, you will continue to take your current medication, as prescribed by your regular doctor. However, there are some medications that are prohibited to take while on the study. Your doctor may wish to contact the study staff (with your permission) to request additional information.
How will I take the study drug?
At Week 0 of the double-blind treatment period, a qualified member of the study staff will give your first dose of the study drug via intravenous (IV) infusion. A small tube attached to a needle will be put into a vein in your arm.
At Week 8 and every 8 weeks until Week 48, a qualified member of the study staff will inject the study drug under the skin using a syringe filled with the study drug (6 injections in total).
If you take part in the extension period, you will be encouraged to inject the investigational drug (no placebo) yourself using a syringe filled with the investigational drug.
If you are unable to, or unwilling to inject yourself at home, you will be asked to return to the study clinic so that a qualified member of the study staff can inject the investigational drug.
How often will I take the study drug?
After you have been assigned to your study treatment group, a qualified member of the study staff will give you one IV infusion of the study drug. For the remainder of the double-blind treatment period, a qualified member of the study staff will give you SC injections of the study drug every 8 weeks until Week 48 (6 injections in total). During the extension period, you will receive an SC injection of the investigational drug only (no placebo) every 8 weeks for 104 weeks (14 injections in total).
Can I take the study drug at home?
During the double-blind treatment period, you will take the study drugs at the study clinic. If you take part in the extension period, you will be encouraged to inject the investigational drug yourself using a syringe filled with the investigational drug. If you are unable to, or unwilling to inject yourself at home, you will be asked to return to the study clinic so that a qualified member of the study staff can inject the investigational drug. Transportation assistance to and from the study clinic is available. Check with the study team for further information.
What happens during visits to the study clinic?
During visits to the study clinic, you will undergo a number of tests to monitor your health and determine how your body is responding to the study drug. Additional visits to the study clinic may be required. This will be decided by the study doctor. The following assessments will occur at some point during the study:
- Questions about you, your health, medical history, current and previous medications you have been or are taking
- Questions about any side effects you may experience
- Responses and/or reactions to infusion/injection of study drug
- Completion and review of diary cards – you will be asked to record other medications taken between visits to the study clinic
- Completion and review of medication diary (for participants in the extension period only) – you will be asked to record the time, dose and location of each injection
- Physical examination, including measurements of height and weight
- ECG (electrocardiogram) – a machine will measure the electrical activity of your heart
- Chest X-ray – a procedure that takes pictures of the inside of your body
- Test for other diseases, such as HIV, hepatitis B/C and tuberculosis
- Blood and urine samples taken
- Measurements of your blood pressure, heart and breathing rate, and temperature
- Pregnancy test, if appropriate
- Assessment of any changes in your health, visits to the hospital and disease progression
- Complete questionnaires about how you are feeling, pain and fatigue levels, and how SLE is affecting your life
- Assessment of your condition and symptoms associated with SLE
- Photographs of your skin lesions may be required (with your consent)
How do I take part?
If you are interested in taking part in the LOTUS Study, just follow these three steps:
- Check the criteria. You should:
- Be 16–75 years of age
- Have had SLE for at least 3 months
- Not be responding to your current treatment for SLE
There are additional criteria that must be met to qualify as a participant.
- Take the pre-qualification screener. If you pre-qualify for the LOTUS Study, you will be referred to your nearest study clinic.
- Visit the study clinic, where the study staff will:
- Discuss the study in more detail and explain what participation would mean for you.
- Talk through the potential benefits and risks of being involved in the study.
- Ask questions and carry out medical tests to determine whether you are right for the study and the study is right for you.
Prior to any procedures taking place, you must agree to and sign an Informed Consent Form. This document explains the study in detail, including potential risks and benefits, as well as your rights and responsibilities.
If you are eligible to participate, all study-related care will be provided without charge. If you do decide to participate, you may withdraw from the study at any time for any reason.