Clinical Research Directory

A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)

The purpose of this study is to evaluate how well LY4005130 works in participants with severe alopecia areata (hair loss) when compared with placebo, and how well it's tolerated and what side effects may occur. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study drug will be administered intravenously (IV) (into a vein in the arm). The study will last approximately 48 weeks, including screening.

A Study of LAD603 in Adults With Alopecia Areata

The main aim of the study is to evaluate the effect of LAD603 in adult participants with severe to very severe alopecia areata (AA). The study will also evaluate the safety, pharmacokinetics (PK), immunogenicity and pharmacodynamic (PD) biomarkers of LAD603.

Utilization and Effectiveness of Ritlecitinib in a Real-World Population With Severe AA in the US

Alopecia areata (AA) is a chronic, relapsing T-cell mediated autoimmune disease characterized by nonscarring, typically patchy hair loss that affects people of all ages, races, and genders. In the United States (US), AA has an estimated point prevalence of 1.14% (Beningo et al., 2020). The three most common subtypes of AA are defined by the affected area: * Patchy alopecia (PA), as seen in 90% of clinical diagnoses: hair loss occurring in one or more patches (ranging from coin-sized to large patches and even full scalp involvement) on the scalp or other parts of the body; * Alopecia totalis (AT): loss of all or nearly all scalp hair; * Alopecia universalis (AU): loss of all or nearly all scalp, face, and body hair Traditionally, a range of medications, including corticosteroids, immunotherapy, and minoxidil, are used to treat AA. However, few of these mainstay therapies are supported by robust clinical evidence, limiting the development of widely accepted clinical practice guidelines (Asfour et al., 2023). As a result of suboptimal effectiveness of traditional therapies, patients with AA, particularly those with extensive hair loss, have a persistent unmet medical need. Furthermore, the potential effects of AA on other subgroups, including patients with skin of color, remain undefined. As these subgroups have been historically underrepresented in clinical trials, an additional unmet medical need and evidence gap exists for these patients. Recent clinical studies have demonstrated efficacy of novel treatments for AA, including ritlecitinib, a JAK3/TEC family kinase inhibitor developed and marketed by Pfizer (King et al., 2023). Ritlecitinib was approved by the US Food and Drug Administration (FDA) in June 2023 for the treatment of severe AA in adults and adolescents aged 12 years or older. Extensive information from clinical trials exists on the safety and efficacy of ritlecitinib, which, along with JAK inhibitors such as baricitinib and deuruxolitinib that are FDA approved for severe alopecia areas in adults 18 and over, have presented needed new therapeutic options for these patients. However, little is known about the clinical effectiveness of ritlecitinib in real-world clinical practice. The objective of the current study is to evaluate patient characteristics, treatment patterns and related clinical outcomes of patients who initiated ritlecitinib to treat severe AA.

A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata

The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of alopecia areata. Alopecia areata is a disease that causes hair loss on the scalp, face, and areas of the body. Ritlecitinib is approved in many countries at a dose of 50 mg (milligram) taken by mouth once a day for the treatment of patients 12 years and older with severe alopecia areata. This study will look at both the 50 mg dose and a 100 mg dose. This study is seeking participants who: * Are 12 years of age or older * Have a diagnosis of alopecia areata * Have lost 50% or more of the hair on their scalp * Do not have any other conditions that causes hair loss * Are willing to stop all other treatments that they may be taking for alopecia areata About 550 participants will take part in in this study. Participants will be chosen by chance, like drawing names out of a hat, to receive 1 of 2 different amounts of ritlecitinib (50 mg and 100 mg) taken by mouth once daily. The 2 doses of ritlecitinib in this study will be compared to each other and also to data from previous studies. This will help to see if the 100 mg dose of ritlecitinib is safe and effective. People will be in this study for about 13 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as: * alopecia areata assessment, * physical examinations, * hearing tests, * blood tests, * x-ray, * ECG (electrocardiogram), * photographs of the scalp and eyes. Participants will also be asked to complete questionnaires about their alopecia areata.

A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo

This is a multi-center, parallel-group, open-label, randomized, Phase 1b study to explore the safety, clinical activity, pharmacokinetics and pharmacodynamics of DR-01 in adults with Alopecia Areata or Vitiligo.

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA. Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 and Study 4 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 and Study 4 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1, Study 2 or Study 4, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 280 sites worldwide. Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)

Part A is a randomized, double-blind, placebo-controlled, multi-center Proof-of-Concept (POC) Trial in subjects with severe Alopecia Areata. All participants in Part A have completed participation. Part B is a multicenter, open-label study to assess the efficacy, safety, and tolerability of bempikibart (ADX-914) in participants with severe Alopecia Areata.

Improving Disease Severity

Phototherapy, including ultraviolet B (UVB) and ultraviolet A (UVA) light, has been used to treat a number of dermatologic conditions. Psoriasis is one of the most common conditions treated with phototherapy, in which phototherapy is often indicated for extensive disease with contraindications for other systemic treatments. The mechanism of action of phototherapy for the treatment of psoriasis is not completely understood; however, it is known that UVB light induces apoptosis of pathogenic T cells and keratinocytes, which may reduce the overactive immune response and epidermal hyperproliferation. Phototherapy has shown some efficacy for other diseases, such as alopecia areata (AA) and polymorphous light eruption (PMLE). However, phototherapy is not always an accessible treatment option for patients due to cost or lack of time.

Safety and Efficacy of Oral NXC-736 in Adult Participants With Moderate and Severe Alopecia Areata

The purpose of this study is to evaluate the safety and efficacy of NXC-736 monotherapy in participants with severe alopecia areata (AA).

A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)

This is an interventional, randomized, double blind, parallel group, placebo-controlled, Phase 2b, 3-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with severe to very severe alopecia areata. The estimated duration includes a screening period of up to 35 days, a 36-week treatment period, an optional 16-week treatment extension period, and a 24-week follow-up period. The maximum study duration is approximately 81 weeks for all participants.

Association of Serum VEGF-A and VCAM-1 Levels With Nailfold Capilleroscopic Alterations in Alopecia Areata

The goal of this observational study is to learn about microvascular changes and hair follicle activity in patients with alopecia areata. The main questions it aims to answer are: Do blood levels of markers related to blood vessel formation (VEGF-A) and inflammation (VCAM-1) differ between patients with alopecia areata and healthy individuals? Is there a link between these blood markers and structural changes in the nailfold capillaries? How do these markers relate to specific trichoscopic signs of disease activity (such as black dots or exclamation mark hairs) and the overall severity of hair loss (SALT score)? Researchers will compare patients with alopecia areata (grouped by disease duration: acute \<6 months vs. chronic \>6 months) to healthy volunteers to see if there is a significant difference in systemic and local vascular indicators. Participants will: Undergo a trichoscopic scalp examination to identify markers of disease activity (black dots, yellow dots, exclamation mark hairs) and calculate the SALT score. Have their nailfolds examined with a digital capillaroscope (50x) to detect microvascular alterations. Provide a blood sample to measure the levels of VEGF-A and VCAM-1.

A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC

TARGET-DERM is a longitudinal, observational study of adult and pediatric patients being managed for Atopic Dermatitis and other Immune-Mediated Inflammatory Skin Conditions (IMISC) in usual clinical practice. TARGET-DERM will create a research registry of patients with IMISC within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

Topical Methotrexate vs Minoxidil for Localized Alopecia Areata

Alopecia areata is an autoimmune disorder characterized by well-defined, non-scarring patches of hair loss on the scalp and other hair-bearing areas. Although several treatment options are available, there is no universally accepted standard therapy, and treatment responses vary widely among patients. Minoxidil is commonly used for hair regrowth due to its ability to stimulate hair follicles and prolong the anagen phase of the hair cycle. Methotrexate, an immunosuppressive agent traditionally used in inflammatory and autoimmune diseases, has also been explored as a potential treatment for alopecia areata because of its ability to suppress immune-mediated follicular damage. This randomized controlled trial aims to compare the efficacy and safety of topical methotrexate 1% gel versus minoxidil 5% spray in patients with localized alopecia areata. Eligible participants will be randomly assigned to receive either topical methotrexate gel or minoxidil spray and will be followed for 24 weeks. Treatment response will be assessed using the Severity of Alopecia Tool (SALT) score. The findings of this study may help identify an effective therapeutic option for patients with localized alopecia areata and contribute to improving clinical management strategies for this condition.

Comparison of Topical Calcipotriol and Intralesional Steroids in Alopecia Areata

This randomized controlled trial compares the effectiveness of topical calcipotriol and intralesional corticosteroids in the treatment of alopecia areata. Alopecia areata is an autoimmune condition that causes non-scarring hair loss and can significantly affect quality of life. Intralesional corticosteroids are commonly used as first-line therapy; however, response rates vary and treatment may be associated with discomfort and local adverse effects. Sixty adult patients with patchy alopecia areata involving less than 50% of the scalp were randomly assigned to receive either topical calcipotriol or intralesional corticosteroid injections for 12 weeks. Participants were evaluated at four-week intervals. Treatment response was assessed using the Severity of Alopecia Tool (SALT) score and percentage improvement from baseline. The primary objective is to compare reduction in SALT score between the two treatment groups. Secondary outcomes include overall treatment efficacy and safety. The findings aim to determine whether topical calcipotriol provides superior or comparable clinical benefit to intralesional corticosteroids in patients with alopecia areata.

Litfulo Capsules Special Investigation

The objective of this Study is to confirm the safety during the long-term use of this drug and the effectiveness during the use of this drug under the actual use in the patients treated with this drug.

Dupilumab in the Treatment of Pediatric Alopecia Areata

This is a prospective, randomized, double-blind, placebo-controlled clinical trial. The study will take place at four sites. This trial will enroll a total of 76 children and adolescents with moderate to severe AA (affecting at least 30% of the scalp) at the time of screening with a targeted 61 participants completing through Week 48. All subjects must have evidence of hair regrowth within the last 7 years of their last episode of hair loss; and have screening IgE ≥200 and/or have personal and/or familial history of atopy. Study participation will be up to 124 weeks, consisting of: a screening period of up to 4 weeks; a 48-week placebo-controlled period; a 48-week open-label extension period; followed by a 24-week follow-up period.

Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib

Alopecia areata (AA) is a chronic relapsing autoimmune disease characterized by nonscarring hair loss affecting children, adolescents, and adults across all ages, races, and genders. AA primarily affects the scalp; however, it also can affect nails, eyelashes, eyebrows, and other hair follicles on the patient's body. The 3 main types of AA are: * Patchy alopecia (PA), as seen in 90% of clinical diagnoses * Alopecia totalis (AT), that affects all scalp hair * Alopecia universalis (AU), involving all scalp, face, and body hair Dermatologist preferences for utility and order of skin-directed therapies to treat AA vary widely, with treatment choices based on various factors such as patients' age, disease duration and severity (Meah et al., 2020). Ritlecitinib is a bioavailable small molecule that irreversibly binds to Janus kinase-3 (JAK3) and Tyrosine kinase Expressed in the hepatocellular Carcinoma kinase family (TEC). Ritlecitinib 50 mg once daily was approved by the FDA 23 June 2023 and EMA 20 July 2023 for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older. In Japan, ritlecitinib was approved on 26 June 2023 for the treatment of alopecia areata (limited to intractable cases involving widespread hair loss). Additional countries have since approved ritlecitinib. Those approvals are based on the results of the ritlecitinib pivotal phase 2b/3 study (ALLEGRO 2b/3) which examined efficacy and safety of ritlecitinib in AA patients globally. Despite positive results from the ALLEGRO program, there is still lack of evidence on ritlecitinib patients' characteristics and clinical outcomes in routine clinical practice. The investigators will evaluate patient and disease characteristics, treatment patterns, and clinical and patient-reported outcomes among patients with AA who are receiving ritlecitinib. The aim of this study is to measure effectiveness of ritlecitinib in a real-world setting. Ritlecitinib will be prescribed to patients according to the approved product label. Treatment will be guided by clinical judgement of the treating physician ie, study investigators, according to standard of care, independently of this study.

A Real World Study to Globally Assess Disease Burden in Adolescent and Adult Participants With Alopecia Areata, Vitiligo, or Hidradenitis Suppurativa

This study is to assess the burden of disease in adolescent and adult participants with moderate or severe alopecia areata (AA), non-segmental vitiligo (NSV), or moderate to severe hidradenitis suppurativa (HS) in a large global real-world participant population.

Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA)

This study will compare two oral medicines-tofacitinib and methotrexate-for treating severe alopecia areata, including alopecia totalis (loss of all scalp hair) and alopecia universalis (loss of scalp and body hair). Alopecia areata is an autoimmune condition that can cause significant hair loss and emotional distress. Adults aged 18 to 60 years with severe disease will be enrolled at the Department of Dermatology, MTI-Hayatabad Medical Complex, Peshawar, after ethical approval and written informed consent. Participants will be randomly assigned to receive either tofacitinib 10 mg twice daily or methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks. The main outcome will be improvement in hair loss measured by the Severity of Alopecia Tool (SALT) score. Treatment will be considered effective if there is more than 50% improvement in SALT score from baseline at the end of 12 weeks. Safety will be monitored during follow-up visits. The findings may help guide treatment decisions for severe alopecia areata in our local population.

CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry

Prospective observational registry focusing on an adolescent cohort diagnosed with severe alopecia areata,receiving routine care from dermatology providers. Visit schedules for patients will be determined by the provider in accordance with routine clinical care, and any prescriptions provided to patients will adhere to product availability and local prescribing guidelines/regulations in the country where the participating registry site is located.

CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry

Prospective, observational cohort study for subjects with AA under the care of a dermatology provider. Approximately 5,000 subjects and 100 clinical sites in North America will be recruited to participate with no defined upper limit for either target.

PALLAS Laser for Skin Diseases

The primary objective of this study is to get clinical experiences with the PALLAS laser in the treatment of skin conditions that respond well to UV light (vitiligo, psoriasis, alopecia areata, atopic dermatitis). The secondary objective is to assess how user-friendly is the Pallas laser in the treatment of skin diseases. The patient in the trial will receive UVB laser treatment (2 treatments per week for up to 3 months). The treatments will be carried out by the doctors participating in the trial. The treatment takes approximately 10 minutes per session, and can last up to 3 months per patient. Photographic documentation of the lesions to be treated and the lesions treated is taken at the start of the examination and then once a month. At the end of the study, the patient rates the treatment and improvement on a Patient Satisfaction Scale.

Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome

This is a single-center, open-label, basket phase 2b trial that will enroll Down Syndrome (DS) participants with at least one inflammatory skin condition (Atopic Dermatitis (AD) and/or Alopecia Areata (AA)). Patients will receive Abrocitinib 100 mg daily for 12 weeks. Responders (defined as achieving Eczema Area and Severity Index (EASI) 75 response for AD, or SALT \<= 20 for AA) will be kept on this dose, and non-responders based on these definitions, will initiate 200 mg daily for another 12 weeks. All AD and AA patients will be maintained on the respective dose of Abrocitinib from Week 24 through week 60.

Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata

This study evaluates the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have 50% or greater scalp hair loss.