A phase 2B, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of Rezpegaldesleukin in the treatment of severe to very severe alopecia areata in adult patients (Rezolve AA)
Alopecia areata is an autoimmune condition where the body's natural defences mistakenly attack healthy hair follicles, leading to significant hair loss on the scalp and body. This clinical trial is testing a new study medicine called rezpegaldesleukin (also known as NKTR-358) in adults who have severe or very severe hair loss. Researchers want to find out whether this drug can safely help hair grow back over 36 weeks of treatment. To ensure fair and reliable results, some participants will receive the active study medicine, while others will receive a placebo (an inactive dummy treatment). Neither the participants nor the study doctors will know who gets which treatment during the study. Regular hospital visits will allow doctors to check your scalp, measure any hair regrowth, run routine health checks, and monitor for any side effects.
At a glance
What is this study about?
Alopecia areata is an autoimmune condition that causes hair to fall out in patches, and in severe cases, it can lead to total hair loss on the scalp or body. It happens because the immune system—which normally protects us from bugs and infections—gets confused and attacks the body's own hair roots. For many people, living with severe hair loss can be upsetting and difficult, and current treatments do not always work well for everyone.
This study, called Rezolve AA, is testing an experimental medicine named rezpegaldesleukin (NKTR-358). Scientists designed this medicine to help rebalance the immune system so that it stops attacking hair follicles. The main goal is to find out whether this treatment can safely encourage significant hair regrowth in adults who have severe or very severe alopecia.
During the trial, doctors will track hair growth using a standard medical scale called the SALT score, which measures how much hair has returned to the scalp. By comparing the results of people taking rezpegaldesleukin with those receiving an inactive dummy treatment (placebo), the study team hopes to learn whether the new medicine is both effective and safe for long-term use.
Key takeaways
- Testing a new medicine called rezpegaldesleukin for severe alopecia areata.
- Open to adults aged 18 and older with substantial scalp hair loss.
- A placebo-controlled study lasting at least 36 weeks.
- Aims to rebalance the immune system and encourage hair regrowth.
- Participation is completely voluntary, and you can leave at any time.
Who may be eligible?
This study is open to men and women aged 18 and older who have been diagnosed with severe or very severe alopecia areata. This generally means you have lost a significant amount of hair on your scalp that has not improved on its own.
Because this is an early-to-mid-stage study, participants must be in generally stable overall health. The study doctors will review your medical history to ensure it is safe for you to take part.
You might not be able to join if you have certain other autoimmune diseases, active serious infections, or are taking medications that strongly affect your immune system. Women who are pregnant or planning to become pregnant may also be excluded to protect their safety.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with severe or very severe alopecia areata.
- I have noticeable, substantial patches of hair loss on my scalp.
- I am willing to attend regular hospital or clinic appointments for about 9 months.
- I am open to receiving either the study drug or a dummy treatment (placebo).
What does participation involve?
If you decide to take part, your involvement will last for at least 36 weeks (around 9 months). You will be randomly placed into a group by a computer, receiving either the study medicine (rezpegaldesleukin) or a placebo. You will have regular appointments at a hospital or specialist clinic—typically every few weeks, especially around weeks 12, 16, 20, 24, 28, 32, and 36. During these visits, doctors will closely examine your scalp, take photographs or measurements of your hair growth, take blood samples, and check your overall health and well-being.
Potential risks and benefits
Locations (1)
- —UnverifiedPoland
Common questions
What is a placebo?
A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It helps scientists see if any improvements are truly caused by the new drug.
Can I choose whether I receive the real medicine or the placebo?
No. A computer randomly decides which treatment you receive. Neither you nor your study doctor can choose, and neither of you will know which one you are getting until the study ends.
Does taking part cost anything?
No. The study medication, clinic visits, and all trial tests are provided free of charge. Many trials also help cover travel expenses to and from the clinic.
Can I keep using my current hair loss treatments?
Usually, you will need to stop other hair loss treatments before joining so researchers know that any changes are due to the study medicine. Always talk to the trial doctor before stopping any medication.
What happens if I change my mind during the trial?
You are completely free to leave the study at any time. Your decision will not change the standard of healthcare you receive from your regular doctors or the NHS.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.