PF-06651600 for the Treatment of Alopecia Areata - Full Text View - ClinicalTrials.gov (2023)

  • Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4 [TimeFrame:Week 24]

    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported.


  • Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1 [TimeFrame:Week 24]

    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported.


  • Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24 [TimeFrame:Week 24]

    PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.


  • Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 20 at Week 24: Maximum Effect (Emax) Model [TimeFrame:Week 24]

    The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=20 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=20 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.


  • Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 10 at Week 24: Maximum Effect (Emax) Model [TimeFrame:Week 24]

    The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=10 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=10 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.


  • Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48 [TimeFrame:Week 4, 8, 12, 18, 28, 34, 40, and 48]

    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.


  • Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48 [TimeFrame:Week 4, 8, 12, 18, 28, 34, 40, and 48]

    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <=10 were reported.


  • Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 [TimeFrame:Week 4, 8, 12, 18, 24, 28, 34, 40, and 48]

    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. A SALT 75 response was a 75% or greater reduction from baseline in SALT score.


  • Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24 [TimeFrame:Baseline (Day 1), Week 4, 8, 12, 18, and 24]

    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.


  • Change From Baseline in SALT Score at Week 28, 34, 40, and 48 [TimeFrame:Baseline (Day 1), Week 28, 34, 40, and 48]

    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.


  • Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 [TimeFrame:Week 4, 8, 12, 18, 24, 28, 34, 40, and 48]

    EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow, where higher scores represent less hair loss of eyebrows.


  • Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 [TimeFrame:Week 4, 8, 12, 18, 24, 28, 34, 40, and 48]

    ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash, where higher scores represent less hair loss of eyelash.


  • Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 [TimeFrame:Week 4, 8, 12, 18, 24, 34, 40, and 48]

    PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.


  • Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations [TimeFrame:Baseline (Day 1), Week 4, 8, 12, 18, and 24]

    AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.


  • Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations [TimeFrame:Baseline (Day 1), Week 34, 40, and 48]

    AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.


  • Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 [TimeFrame:Week 4, 8, 12, 18, 24, 34, 40, and 48]

    AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over the past week. Items 1-4 were to assess the current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on a scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss', where higher scores indicated more hair loss.


  • FAQs

    What is the best treatment for alopecia areata? ›

    INTRALESIONAL CORTICOSTEROID INJECTIONS

    This method of treatment — the most common form of treatment for alopecia areata — uses corticosteroids that are injected into bare patches of skin with a tiny needle. These injections are repeated about every four to six weeks and are usually given by a dermatologist.

    What is the latest treatment for alopecia areata? ›

    In June 2022 , a medication called baricitinib (Olumiant) received approval from the Food and Drug Administration (FDA) to treat severe cases of alopecia areata. It's the first FDA-approved systemic treatment for alopecia. This type of systemic treatment helps treat hair loss all over the body.

    Did Pfizer just get a treatment approved for alopecia? ›

    Pfizer PFE announced that the FDA has accepted its new drug application (NDA), seeking approval of ritlecitinib, its investigational JAK3 inhibitor for severe alopecia areata (“AA”).

    When will JAK inhibitors be approved for alopecia? ›

    In a June 13 announcement, the U.S. Food and Drug Administration approved the use of the Janus kinase (JAK) inhibitor baricitinib as a treatment for severe alopecia areata, a disfiguring skin disease.

    What really works for alopecia? ›

    The most common options include: Minoxidil (Rogaine). Over-the-counter (nonprescription) minoxidil comes in liquid, foam and shampoo forms. To be most effective, apply the product to the scalp skin once daily for women and twice daily for men.

    What is the best natural treatment for alopecia areata? ›

    Rosemary oil has been found to stimulate new hair growth and can even be used to treat androgenetic alopecia. Mix a few drops of rosemary oil into a carrier oil, like argan oil or jojoba oil, and massage it into your hair and scalp before rinsing. You can do this a few times per week.

    What is the FDA approved drug for alopecia? ›

    Today, the U.S. Food and Drug Administration approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year.

    What is the best FDA approved hair loss treatment? ›

    Finasteride (Propecia) and Minoxidil (both oral and topical - Rogaine) are the only drugs approved by the FDA to treat pattern baldness (hair loss resulting from hereditary causes). Oral minoxidil is more effective than topical minoxidil in prevnting hairloss and stimulating regrowth.

    Is there a permanent cure for alopecia? ›

    However, alopecia areata cannot be "cured." As noted above, most patients experience future episodes of hair loss. Corticosteroids — Corticosteroids, commonly called steroids, are anti-inflammatory medications that are used to treat alopecia areata.

    Is anyone working on a cure for alopecia? ›

    Many pharmaceutical companies are working on developing new treatments for alopecia. Many of the current go-to treatment options aren't effective or ideal options for people living with the condition. In June 2022, the FDA approved Olumiant (baricitinib) as a new treatment option for adults with severe alopecia.

    What is the name of the new pill for alopecia? ›

    The U.S. Food and Drug Administration (FDA) has approved the drug Olumiant (baricitinib) for adult patients with severe alopecia areata, an immune disorder that often results in hair loss. The medicine is the first FDA approval of a systemic or full-body drug for the condition, per a statement.

    What does Pfizer have to do with alopecia? ›

    Pfizer is currently researching a potential treatment on patients with AA. “It inhibits a particular JAK pathway that has been shown to be important in Alopecia,” says Yamaguchi. An FDA approved medicine would make a real difference for people like Gregory, who now leads a support group for other AA patients.

    How effective is tofacitinib for alopecia? ›

    Janus kinase inhibitors have been shown to attenuate the inflammatory cascade associated with AA. Our results indicate that tofacitinib is efficacious in the treatment of AA. Although small, our cohort achieved greater median improvement in SALT scores than reported in previously published studies (50.5% vs 21%).

    Which JAK inhibitor is best for alopecia? ›

    Olumiant is a prescription medication that is a Janus kinase (JAK) inhibitor, and is used to treat adults with severe alopecia areata.

    Is tofacitinib approved for alopecia areata? ›

    Tofacitinib citrate is a Janus kinase 1/3 inhibitor approved for the treatment of rheumatoid arthritis, but it has recently been used to treat alopecia areata (AA).

    What shampoo is good for alopecia? ›

    Ketoconazole shampoos help treat Alopecia by cleaning the skin area around your hair follicle of sebum, or the skins natural oils that are produced. Getting rid of these oils can allow your hair follicles to receive more nutrition and release for your hair to regrow.

    What triggers alopecia areata? ›

    Causes of Alopecia Areata

    In alopecia areata, the immune system mistakenly attacks hair follicles, causing inflammation. Researchers do not fully understand what causes the immune attack on hair follicles, but they believe that both genetic and environmental (non-genetic) factors play a role.

    What can make alopecia worse? ›

    When stress levels are high, it's more likely that you'll lose hair. While alopecia isn't specifically linked to stress, it's more likely to flare up during times when you're experiencing high levels of stress.

    What herb cures alopecia? ›

    Giant dodder (Cuscuta reflexa Roxb): According to a 2008 study , giant dodder — a sprawling, Ayurvedic plant — helps treat alopecia caused by steroid hormones by inhibiting the 5a reductase enzyme.

    What foods help get rid of alopecia? ›

    Eat plenty of protein and healthy fats.

    A diet rich in omega oils and antioxidants to reduce oxidative stress placed on the hair by the environment, as well as some seafood rich in minerals and vitamins, can help with hair growth,” St. Surin-Lord says.

    What is the only FDA approved ingredient that can help regrow hair? ›

    In the United States, topical minoxidil is an oft-recommended chemical hair growth ingredient, and it's one of the only approved by the FDA for hair regrowth.

    How much is the new alopecia drug? ›

    On June 13, 2022, the FDA approved the first systemic treatment for severe alopecia areata: the oral tablet baricitinib (Olumiant). Without insurance coverage, baricitinib costs around $2,500 and $5,000 per month for 2-mg or 4-mg tablets, respectively.

    Which steroid is best for alopecia areata? ›

    Intralesional corticosteroids: Intralesional corticosteroids are widely used in the treatment of alopecia areata. In fact, they are the first-line treatment in localized conditions involving <50% of the scalp22. Hydrocortisone acetate (25mg/ml) and Triamcinolone acetonide (5-10mg/ml) are commonly used.

    What lack of vitamin causes hair loss? ›

    Only riboflavin, biotin, folate, and vitamin B12 deficiencies have been associated with hair loss.

    What is the best hair loss treatment in the world? ›

    Minoxidil (Rogaine) is regarded as one of the most effective hair loss treatments. Topical minoxidil can be an effective treatment for androgenic hair loss,. Some studies demonstrate improvement in up to 70 percent of users. Every hair loss treatment will affect people differently, though.

    What vitamin should I take for hair loss? ›

    1. Biotin. Biotin (vitamin B7) is important for cells inside your body. Low levels of it can cause hair loss, skin rashes, and brittle nails.

    Can anything reverse alopecia? ›

    Can Alopecia Be Reversed? Whether your hair loss is caused by hormones or an autoimmune disorder, regrowing your hair by using new medications and modifying your diet can be possible as long as you start treatment early.

    What type of alopecia is reversible? ›

    Telogen effluvium, which is diffuse hair shedding due to a stressor, usually recovers spontaneously over 6-12 months even without treatment.

    How do I stop autoimmune hair loss? ›

    Treatment options for alopecia areata include: Corticosteroids: anti-inflammatory drugs that are prescribed for autoimmune diseases. Corticosteroids can be given as an injection into the scalp or other areas, orally (as a pill), or applied topically (rubbed into the skin) as an ointment, cream, or foam.

    Is alopecia related to gut health? ›

    The alopecia was thought to be a consequence of faulty digestion, rather than the primary condition. It appears that many sufferers of alopecia do have some form of digestive condition, or have been through a prolonged period of stress or anxiety which hinders digestion and alters gut flora.

    What is the fastest way to recover from alopecia? ›

    If you are older than 10 years of age and have a few patches of alopecia areata, your dermatologist may recommend one or more of the following treatments: Injections of corticosteroids: To help your hair regrow, your dermatologist will inject this medication into the bald areas.

    What are the 4 types of alopecia? ›

    The autoimmune disease known as alopecia areata is also an umbrella term that encompasses the other forms like alopecia totalis, alopecia universalis, diffuse and ophiasis alopecia areata.

    What are the 3 types of alopecia? ›

    Most people know alopecia to be a form of hair loss. However, what they don't always know is that there are three main types of the condition – alopecia areata, alopecia totalis and alopecia universalis.

    How does alopecia affect the brain? ›

    Though the symptoms of alopecia areata typically do not cause physical pain, many people with the condition say that it causes emotional, or psychological, pain. This type of pain is as serious (and can feel the same) as physical pain and can lead to feelings of sadness, depression and anxiety.

    How long can you take tofacitinib for? ›

    For ulcerative colitis: For oral dosage form (extended-release tablets): Adults—22 milligrams (mg) once a day for at least 8 weeks, then 11 mg once a day. Your doctor may adjust your dose as needed.

    Are JAK inhibitors safer than biologics? ›

    Because both suppress the immune system, they increase your risk of serious infections and certain cancers. JAK inhibitors may be safer because they aren't linked to any allergies. Biologic drugs may cause an allergic reaction in a small amount of people.

    How fast does tofacitinib work? ›

    Most patients notice an improvement in symptoms by one month of starting treatment. Your rheumatologist may want to make sure you have had any needed vaccines before starting this medication. Live vaccines, such as the shingles vaccine, should not be given while on Tofacitinib.

    Do JAK inhibitors work for alopecia? ›

    Treatment with three JAK inhibitors, ruxolitinib, baricitinib and tofacitinib, led to hair regrowth in alopecia areata patients, and similar effects have also been demonstrated in animal models for alopecia areata.

    Is there a natural JAK inhibitor? ›

    Several fruits were potent inhibitors of JAK2: blackberry, boysenberry, feijoa, pomegranate, rosehip and strawberry, which all contain ellagitannins, known inhibitors of kinases. These fruits are in the Rosales and Myrtales plant orders. No other foods gave >1% of the maximal JAK2 inhibitory activities of these fruits.

    Are JAK inhibitors better than methotrexate? ›

    A selective Janus kinase (JAK1) inhibitor, upadacitinib, is superior to methotrexate in improving clinical outcomes in patients with early rheumatoid arthritis (RA), a study in Arthritis and Rheumatology has suggested.

    Is Pfizer making a new drug for alopecia? ›

    (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata. The FDA is expected to make a decision in the second-quarter 2023.

    Does Pfizer have a new drug for alopecia? ›

    Pfizer PFE announced that the FDA has accepted its new drug application (NDA), seeking approval of ritlecitinib, its investigational JAK3 inhibitor for severe alopecia areata (“AA”). The FDA granted a standard review to the NDA with a decision expected in the second quarter of 2023.

    How can I permanently get rid of alopecia? ›

    Is there a permanent cure for alopecia? Not currently. However, there are several treatment options that might slow down hair loss or even help your hair grow back faster.

    What should be avoided in alopecia areata? ›

    On the AIP elimination diet, you will avoid grains, legumes, nightshades (such as potatoes and peppers), dairy, eggs, coffee, alcohol, sugar, oil and food additives. After a few months, you can work the excluded foods back in one at a time to figure out which foods trigger an inflammatory reaction.

    Does Vitamin D Help alopecia areata? ›

    Calcipotriol, a vitamin D analog, has been reported to be topically used in treating alopecia areata with promising results. Combination therapy of vitamin D analogs with corticosteroids might also be used in treating alopecia areata.

    How do you prevent alopecia areata from getting worse? ›

    Ways to Stop Alopecia Areata from Spreading or Worsening

    Avoiding unnecessary hair or scalp trauma, reducing stress and analyzing your diet are all worthwhile endeavors when attempting to prevent alopecia areata from spreading.

    Has anyone recovered from alopecia areata? ›

    In most people, new hair eventually grows back in the affected areas, although this process can take months. Approximately 50 percent of people with mild alopecia areata recover within a year; however, most people will experience more than one episode during their lifetime.

    Does garlic help alopecia areata? ›

    According to one clinical review , topical garlic was considered one alternative form of medicine that could possibly help treat alopecia areata. However, researchers also note that there's inconsistent evidence supporting such uses. Overall, early research on garlic and hair loss shows promise.

    Can lack of vitamin D cause alopecia areata? ›

    A deficiency in vitamin D can be linked to many different types of autoimmune disease—including alopecia areata. This study found that vitamin D deficiency was a risk factor for developing alopecia areata and that a significant number of patients with this condition had low levels of vitamin D.

    How often should I wash my hair if I have alopecia areata? ›

    Unlike other medications or treatments, alopecia shampoo can be used during your daily routine. As instructed by Mayo Clinic, men will need to apply the shampoo twice a day during morning and evening showers. 2. Some alopecia shampoos may irritate your skin.

    Top Articles
    Latest Posts
    Article information

    Author: Eusebia Nader

    Last Updated: 01/17/2023

    Views: 5636

    Rating: 5 / 5 (60 voted)

    Reviews: 83% of readers found this page helpful

    Author information

    Name: Eusebia Nader

    Birthday: 1994-11-11

    Address: Apt. 721 977 Ebert Meadows, Jereville, GA 73618-6603

    Phone: +2316203969400

    Job: International Farming Consultant

    Hobby: Reading, Photography, Shooting, Singing, Magic, Kayaking, Mushroom hunting

    Introduction: My name is Eusebia Nader, I am a encouraging, brainy, lively, nice, famous, healthy, clever person who loves writing and wants to share my knowledge and understanding with you.