Ongoing Clinical Trials for Alopecia Areata
Currently, there are 8 ongoing clinical trials investigating new treatments for alopecia areata. These studies are testing several medications including baricitinib, ritlecitinib, upadacitinib, etrasimod, and rezpegaldesleukin across multiple European countries. The trials focus on both adults and children, with many specifically designed for patients with severe forms of the condition.
Clinical trial locations
- Belgium
- Bulgaria
- Croatia
- Czechia
- Long-term safety and effectiveness study of ritlecitinib in children with severe alopecia areata who completed previous trials B7981027 or B7981031
- Long-Term Study of Ritlecitinib Tosilate for Adults and Adolescents with Alopecia Areata
- Study of ritlecitinib for treating severe alopecia areata in children aged 6 to under 12 years
- Study on the Effects of Ritlecitinib in Patients Aged 12 and Older with Alopecia Areata
- Espagne
- France
- Long-term safety and effectiveness study of ritlecitinib in children with severe alopecia areata who completed previous trials B7981027 or B7981031
- Study of ritlecitinib for treating severe alopecia areata in children aged 6 to under 12 years
- Study on Baricitinib for Treating Children Aged 6 to 17 with Alopecia Areata
- Study on the Safety and Effectiveness of Upadacitinib for Adults and Adolescents with Severe Alopecia Areata
- Germany
- Greece
- Hungary
- Italy
- Long-term safety and effectiveness study of ritlecitinib in children with severe alopecia areata who completed previous trials B7981027 or B7981031
- Study of ritlecitinib for treating severe alopecia areata in children aged 6 to under 12 years
- Study on the Safety and Effectiveness of Upadacitinib for Adults and Adolescents with Severe Alopecia Areata
- Poland
- Long-term safety and effectiveness study of ritlecitinib in children with severe alopecia areata who completed previous trials B7981027 or B7981031
- Long-Term Study of Ritlecitinib Tosilate for Adults and Adolescents with Alopecia Areata
- Study of ritlecitinib for treating severe alopecia areata in children aged 6 to under 12 years
- Study on Baricitinib for Treating Children Aged 6 to 17 with Alopecia Areata
- Study on Rezpegaldesleukin for Treating Severe Alopecia Areata in Adults
- Study on the Effects of Ritlecitinib in Patients Aged 12 and Older with Alopecia Areata
- Study on the Safety and Effectiveness of Upadacitinib for Adults and Adolescents with Severe Alopecia Areata
- Portugal
- Slovakia
- Spain
- Long-term safety and effectiveness study of ritlecitinib in children with severe alopecia areata who completed previous trials B7981027 or B7981031
- Study of ritlecitinib for treating severe alopecia areata in children aged 6 to under 12 years
- Study on Baricitinib for Treating Children Aged 6 to 17 with Alopecia Areata
- Study on the Effects of Ritlecitinib in Patients Aged 12 and Older with Alopecia Areata
- Study on the Safety and Effectiveness of Upadacitinib for Adults and Adolescents with Severe Alopecia Areata
- Sweden
Study on Baricitinib for Treating Children Aged 6 to 17 with Alopecia Areata
This trial is testing baricitinib, a medication taken as a tablet or oral suspension, in children aged 6 to under 18 years. The study aims to determine whether different doses of baricitinib are more effective than placebo in treating the condition.
Who can participate: Children must have had severe alopecia areata for at least one year, with the current episode lasting at least six months and covering 50% or more of the scalp. The current episode must have lasted less than eight years, though if it has been longer, there must have been periods of natural hair regrowth or regrowth with treatment in the past eight years. Both males and females can participate.
Who cannot participate: Children with other medical conditions that might interfere with the study, those taking medications that could affect results, those with recent infections or illnesses, those with allergic reactions to similar medications, pregnant or breastfeeding participants, those who participated in another clinical trial recently, those with a history of drug or alcohol abuse, and anyone with conditions that doctors believe would make participation unsafe.
What the study involves: Participants will be randomly assigned to receive either a high dose, low dose of baricitinib, or placebo. The medication is taken orally, and throughout the trial, participants will attend regular check-ups to monitor health and medication effects. These visits will include physical examinations and possibly laboratory tests. The main goal is to see if baricitinib can help reduce the severity of hair loss and track the percentage of participants who achieve significant improvement.
Investigational drug: Baricitinib works by blocking certain enzymes involved in the immune response, which may help reduce inflammation and prevent hair loss.
Study on the Effects of Ritlecitinib in Patients Aged 12 and Older with Alopecia Areata
This study tests ritlecitinib tosilate in people aged 12 and older to see how effective two different doses (50 mg and 100 mg) are in helping hair regrow on the scalp. The trial will last 48 weeks, during which participants take the medication daily.
Who can participate: Participants must be 18 years or older at screening, though adolescents aged 12 to under 18 can participate if local regulations allow. They must have a clinical diagnosis with 50% or more hair loss on the scalp as measured by the SALT score, with no significant regrowth in the past six months. Photographs of the scalp must be submitted for verification, and the current episode must have started 10 years ago or less.
Who cannot participate: Those with other autoimmune diseases affecting hair loss, serious infections in the past six months, those taking immune-suppressing medications, those with a history of cancer in the past five years (except certain skin cancers), those who participated in another clinical trial in the past 30 days, pregnant or breastfeeding women, those with allergies to the study medication, and those with uncontrolled medical conditions.
What the study involves: Participants will be randomly assigned to receive either ritlecitinib 50 mg, 100 mg, or placebo once daily. Throughout the study, participants will be monitored for changes in their condition and side effects, with regular follow-up visits to assess hair regrowth and overall health. The primary goal is to evaluate scalp hair regrowth at Week 24 using the SALT score.
Investigational drug: Ritlecitinib is a Janus kinase (JAK) inhibitor that targets specific pathways in the immune system involved in hair loss, helping to restore normal hair growth.
Long-term safety and effectiveness study of ritlecitinib in children with severe alopecia areata who completed previous trials B7981027 or B7981031
This trial studies the long-term effects of ritlecitinib in people with severe forms of the disease who previously participated in related studies. The study uses ritlecitinib in hard capsules taken by mouth, continuing for up to 36 months.
Who can participate: Participants must have previously completed either study B7981027 or B7981031, been diagnosed with the condition (including complete loss of scalp or body hair), and if they participated in study B7981031, must have at least 50% scalp hair loss at both screening and baseline visits. Both males and females, children and adolescents can participate, provided they completed all required visits and procedures in their previous study.
Who cannot participate: Those with previous severe allergic reactions to similar medications, current participation in other trials or use of investigational drugs within 30 days, serious or uncontrolled medical conditions, current active infections requiring treatment, history of cancer within the past five years (except successfully treated non-melanoma skin cancer), pregnant or breastfeeding women or those planning pregnancy, significant liver problems or abnormal liver function tests, severe kidney disease requiring dialysis, untreated or poorly controlled high blood pressure, history of serious heart conditions, current or recent serious infections including tuberculosis or hepatitis, use of medications that could interact with the study drug, mental health conditions affecting ability to follow procedures, drug or alcohol abuse within the past six months, and blood disorders that could affect safety.
What the study involves: Participants will receive either ritlecitinib at doses of 30 mg or 50 mg daily, or placebo. Scalp hair loss will be measured regularly using the SALT score, eyebrows and eyelashes will be evaluated using special assessment tools, and participants will complete questionnaires about treatment effectiveness and emotional well-being. The study continues until May 2030 with regular check-ups monitoring side effects, quality of life assessments, and at Month 36, cognitive abilities will be evaluated.
Investigational drug: Ritlecitinib targets specific proteins in the immune system involved in the process that leads to hair loss.
Study of ritlecitinib for treating severe alopecia areata in children aged 6 to under 12 years
This trial focuses on children aged 6 to under 12 years with severe condition, evaluating how well ritlecitinib works compared to placebo. The treatment period lasts 24 weeks, approximately six months.
Who can participate: Children must be between 6 and 11 years old when starting the study, have been diagnosed with at least 50% scalp hair loss present for at least 12 months without natural regrowth, and have previously tried other treatments that did not work such as topical treatments, other medications, or hair pieces. Both boys and girls can participate. The scalp hair loss must be measured using a SALT score of 50 or higher at both initial screening and baseline visits.
Who cannot participate: Those with serious or active infections including tuberculosis or hepatitis B, compromised immune systems, those who received live vaccines within four weeks before starting, those with significant heart problems or uncontrolled high blood pressure, severe kidney or liver problems, those who have or had cancer in the past five years (except successfully treated skin cancer), pregnant or breastfeeding women, those taking certain interacting medications, those who participated in another clinical trial within the past 30 days, those with history of serious allergic reactions, those with untreated thyroid disease, those with history of blood disorders, those who abuse drugs or alcohol, and those who cannot follow the study protocol or attend regular visits.
What the study involves: Participants will be randomly assigned to receive either ritlecitinib capsules or placebo capsules to be taken by mouth daily for 24 weeks. Neither participants nor doctors will know which treatment is received. Regular check-ups will monitor progress, scalp hair growth will be measured using the SALT score, blood samples will be collected at week 4 or 8 to measure medication levels, and doctors will assess changes in eyebrows and eyelashes if applicable. Participants and guardians will complete questionnaires about feelings and how hair loss affects daily life. The main goal is to achieve a SALT score of 10 or less by week 24, indicating significant hair regrowth.
Investigational drug: Ritlecitinib works by targeting specific enzymes in the body involved in the immune response, which may help reduce inflammation and promote hair regrowth.
Long-Term Study of Ritlecitinib Tosilate for Adults and Adolescents with Alopecia Areata
This trial studies the long-term safety and effectiveness of ritlecitinib tosilate for treating the condition in adults and adolescents. The medication is taken orally as capsules or tablets.
Who can participate: Participants must have a clinical diagnosis with no other reasons for hair loss. New participants aged 12 to under 18 must have at least 50% hair loss on the scalp, while those 18 and older must have at least 25% scalp hair loss. Participants should not have any hair regrowth in affected areas within six months before starting, and the current episode should not be longer than 10 years. Participants from previous related studies must meet specific conditions. All participants must be at least 12 years old (in some regions, only those 18 or older can join). Both males and females can participate, though female participants must not be pregnant or breastfeeding and should use effective birth control if able to have children. Participants must be able to give informed consent, willing to attend scheduled visits, follow treatment plans, and undergo tests. If taking other medications, participants should be on stable doses, and must agree to avoid prolonged sun exposure and not use tanning booths during the study.
Who cannot participate: Those with other medical conditions that might interfere, those currently taking medications that could affect results, those who had recent surgery or are planning surgery during the study, pregnant or breastfeeding individuals, those with history of severe allergic reactions, those who participated in another clinical trial recently, those with history of drug or alcohol abuse, and those with any condition doctors believe would make participation unsafe.
What the study involves: Participants will receive ritlecitinib tosilate orally, with dosage and frequency determined by study protocol and adjusted based on individual response and tolerability. Regular follow-up visits will monitor response to medication and side effects, including physical examinations, laboratory tests, and assessments of hair regrowth. Throughout the study, participants will be monitored for adverse events or side effects. The study is expected to continue until 2026, with participants completing a final follow-up visit or 28 days after the last dose. The primary focus is on the incidence of treatment-related adverse events and overall medication safety.
Investigational drug: Ritlecitinib tosilate is a Janus kinase (JAK) inhibitor that works by inhibiting certain enzymes involved in the immune response, which may help reduce inflammation and prevent hair loss.
Study on Etrasimod Arginine for Patients with Ulcerative Colitis, Alopecia Areata, Atopic Dermatitis, and Eosinophilic Esophagitis
This trial studies etrasimod arginine in the form of mini tablets that can be mixed with different foods or water. The purpose is to learn how the body absorbs the medication when mixed with different foods like applesauce, chocolate pudding, yogurt, or water, and to evaluate how the mini tablets taste.
Who can participate: Participants must be 18 years or older and in good health based on medical check-ups including medical history review, physical exam, blood pressure, heart rate, lab tests, body temperature, and ECG. They should have a Body Mass Index between 16 and 32 kg/m² and weigh more than 50 kg. Participants must be willing to attend all scheduled visits, follow treatment plans, undergo lab tests, and adhere to lifestyle guidelines. They must be able to provide signed informed consent.
Who cannot participate: Those with immune-mediated inflammatory disorders such as ulcerative colitis, alopecia areata, atopic dermatitis, and eosinophilic esophagitis, those not within the specified age range, and those who are part of vulnerable populations.
What the study involves: Participants will take a single dose of etrasimod arginine as a 2 mg mini tablet orally, which may be mixed with water, applesauce, chocolate pudding, or yogurt. Participants will be monitored for plasma levels of etrasimod to assess absorption and maximum concentration in the blood. Additional assessments include monitoring heart rate, adverse effects, clinical laboratory abnormalities, vital signs, physical examinations, and 12-lead ECGs. Participants will complete a questionnaire evaluating the palatability of the mini tablet, focusing on mouth feel, bitterness, burning sensations, and overall liking.
Investigational drug: Etrasimod is a sphingosine-1-phosphate (S1P) receptor modulator that works by modulating the immune system to reduce inflammation and helps control the movement of immune cells in the body.
Study on Rezpegaldesleukin for Treating Severe Alopecia Areata in Adults
This trial tests rezpegaldesleukin, a special form of protein injected under the skin, comparing its effects with placebo to see how well it works in reducing hair loss in adults with severe to very severe condition.
Who can participate: Adults aged 18 to 60 years for males and up to 70 years for females, with a diagnosis of severe to very severe condition and history of the condition for over six months without natural improvement before starting. The current episode must have lasted less than eight years. Women who can have children must have negative pregnancy tests before and at the beginning of the study, and both women and men with partners who can have children must use approved and highly effective birth control methods during treatment and for at least 30 days after the last dose. Participants must be able to complete questionnaires, attend study visits, follow procedures, provide written consent, and communicate, read, and understand the local language.
Who cannot participate: Information about specific exclusion criteria was not provided in the source data.
What the study involves: Participants will receive either rezpegaldesleukin or placebo via subcutaneous injection. Follow-up assessments will occur at Weeks 12, 16, 20, 24, 28, 32, and 36 to monitor changes in the SALT score. The primary goal is to evaluate the percent change in SALT score from baseline at Week 36. The study is estimated to conclude by August 24, 2026.
Investigational drug: Rezpegaldesleukin is an immunomodulatory agent administered via injection that works by modulating the immune system to potentially reduce inflammation and promote hair regrowth.
Study on the Safety and Effectiveness of Upadacitinib for Adults and Adolescents with Severe Alopecia Areata
This trial evaluates the safety and effectiveness of upadacitinib, taken as a modified-release tablet designed to release medication slowly over time. The study compares different doses to placebo in both adults and adolescents.
Who can participate: Adults under 64 years old can participate, and in some places outside the US and EU, adolescents at least 12 years old can also participate. Participants must have a diagnosis of severe condition with a SALT score of 50 or more indicating significant scalp hair loss at both the start and during initial screening. They should not have experienced spontaneous scalp hair regrowth in the past six months or significant scalp hair loss in the past three months. The current episode must have lasted less than eight years.
Who cannot participate: Those with other medical conditions that might interfere, those currently participating in another clinical trial, those with history of allergic reactions to study medication, pregnant or breastfeeding individuals, those with history of drug or alcohol abuse, those with serious infection or illness, those with history of cancer, those with weakened immune systems, those taking medications that might interfere, those who had recent surgery or are planning surgery during the study.
What the study involves: The study is conducted in several phases. Initially, participants take medication or placebo for 24 weeks. Some may continue in an extended phase for up to 160 weeks for long-term evaluation. Participants will be randomly assigned to receive either upadacitinib (15 mg or 30 mg) or placebo taken orally once daily. The primary goal is to achieve a SALT score of 20 or less at Week 24, indicating 20% or less scalp hair loss. Secondary goals include improvements in eyebrow and eyelash hair loss and overall scalp hair assessment. The study includes a blinded extension phase from Week 24 to 52, and a long-term treatment phase from Week 52 to 160 assessing long-term safety and effectiveness.
Investigational drug: Upadacitinib is a JAK inhibitor administered orally in tablet form, typically taken once daily. It works by inhibiting Janus kinase enzymes that play a role in the inflammatory process contributing to hair loss.
Summary
The eight ongoing clinical trials for alopecia areata demonstrate significant research activity across Europe, with Poland emerging as the most active location, hosting seven of the eight trials. Other countries with substantial trial activity include Spain, France, Czechia, and Italy. The geographic distribution shows strong Central and Western European participation, with limited representation from Southern and Eastern Europe.
The trials focus primarily on JAK inhibitors, with ritlecitinib being studied in four separate trials targeting different age groups and treatment phases, and upadacitinib being evaluated in one large multi-country study. Baricitinib is being tested specifically in children, while rezpegaldesleukin and etrasimod represent alternative therapeutic approaches. Most studies require participants to have severe condition with at least 50% scalp hair loss, emphasizing the focus on more advanced cases.
A notable feature is the attention given to pediatric populations, with several trials specifically designed for children aged 6 to 17 years. Long-term safety and effectiveness studies extending up to 160 weeks demonstrate commitment to understanding sustained treatment outcomes. The trials employ standardized measurement tools such as the SALT score to ensure consistent evaluation of treatment effectiveness across different studies.
