Papillion

Researchers are studying the long-term safety and effects of ritlecitinib, an oral medicine, for children with severe alopecia areata, a condition that causes significant hair loss. This Phase 3 trial focuses on participants who completed previous Pfizer studies and have notable scalp hair loss or specific vaccination history. The study aims to understand how well ritlecitinib is tolerated and its impact on hair regrowth and quality of life over time. Participants will take ritlecitinib capsules once daily at home for up to three years. Those who previously received different doses of ritlecitinib will continue the same dose, while others will be randomly assigned to either a higher or lower dose. Dose adjustments and treatment continuation will be evaluated at specific months, with some participants switched to placebo if they do not meet efficacy criteria, though they remain in the study. During the trial, participants will attend 17 clinic visits and receive monthly phone calls. Researchers will monitor safety by tracking adverse events and assess effectiveness using tools like the Severity of Alopecia Tool (SALT), eyebrow and eyelash assessments, and patient-reported outcomes on anxiety, depression, behavior, and quality of life. The study includes ongoing safety checks and measures cognitive function at select points, ensuring thorough evaluation throughout the three-year participation period.

Migraine is a condition that often causes moderate to severe headaches on one side of the head, sometimes accompanied by symptoms like throbbing, nausea, vomiting, and sensitivity to light and sound. This research aims to evaluate the safety and effectiveness of atogepant compared to a placebo in preventing chronic migraine in participants aged 12 to 17 years. Atogepant is already approved for adults and is now being studied for younger patients to understand its impact on this age group. Participants will be randomly assigned to receive either atogepant or a placebo, both given as oral tablets once daily for 12 weeks. The study is designed to be double-blind, so neither the participants nor the doctors will know who receives the active medicine or the placebo. After the 12-week treatment period, participants will be followed for an additional 4 weeks for further observation. During the study, participants will attend regular visits at a hospital or clinic where they will complete daily diaries, undergo medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure the number of participants experiencing adverse events and changes in monthly migraine days, among other outcomes. The total participation time, including treatment and follow-up, will be approximately 16 weeks.

Researchers are evaluating atogepant, a medicine approved for adults, to study its safety and how well it works in children and teens aged 6 to 17 with episodic migraine. Episodic migraine involves moderate to severe headaches on one side of the head, often with symptoms like throbbing, nausea, vomiting, and sensitivity to light and sound. This Phase 3, randomized, double-blind study aims to fill the gap in approved treatments for pediatric migraine sufferers. Participants aged 6 to 17 will be divided into groups receiving either a placebo, low-dose atogepant, or high-dose atogepant tablets once daily for 12 weeks. Children aged 6 to 11 will first be part of a pharmacokinetic substudy to determine the appropriate doses. After the 12-week treatment, participants will either have a follow-up visit 4 weeks later or join an extension study to continue atogepant treatment for an additional 52 weeks. During the study, participants will attend regular visits at hospitals or clinics, where medical assessments, blood tests, side effect checks, and questionnaires will be completed. Researchers will measure changes in the number of migraine and headache days, adverse events, medication use, and quality of life scores. Safety and effectiveness will be monitored throughout the study, which is expected to continue until May 2028.

This research aims to evaluate the safety and effectiveness of IPN10200, a medication designed to prevent episodic and chronic migraine by stopping the release of chemical messengers that cause migraine pain. Adults aged 18 to 80 with a history of migraine for at least one year will participate to help determine the best dose and overall safety profile of IPN10200. The study is a Phase II, randomized, double-blind, placebo-controlled trial sponsored by Ipsen. The study includes three main periods: an initial screening to determine eligibility, followed by Step 1 which tests two doses of IPN10200 in separate cohorts to assess safety over 36 weeks, and Step 2 where new participants are grouped by migraine type and randomly assigned to receive either Dose A, Dose B, or placebo. Treatments are given as injections into muscles of the head, face, and neck in a single treatment cycle for each dose or placebo group. Participants will be asked to complete a daily electronic migraine diary and questionnaires throughout the study lasting up to 44 weeks. Researchers will monitor safety through adverse event reporting, laboratory tests, vital signs, facial examinations, ECG readings, and antibody levels. Efficacy will be assessed by changes in the number of monthly migraine and headache days. Safety and effectiveness data will be collected regularly until the final Week 36 visit.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). This Phase 3 study includes participants who have had at least two moderate or one severe COPD exacerbations in the past year despite inhaled maintenance therapy. The goal is to better understand if tezepelumab can reduce the rate of COPD exacerbations and improve lung function and quality of life. Participants will receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo for a treatment period lasting between 52 and 76 weeks. After the treatment phase, there is a 12-week off-treatment safety follow-up. The study is randomized, double-blind, and placebo-controlled, ensuring that neither participants nor researchers know who receives the active medication or placebo. During the study, participants will have regular assessments including lung function tests, questionnaires about respiratory health and symptoms, and blood samples to measure drug levels and immune response. Researchers will track COPD exacerbation frequency, lung function changes, and symptom improvements. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods, with total participation lasting up to approximately 88 weeks.

Researchers are evaluating the safety and effectiveness of ibuzatrelvir, an oral medication, in adults and adolescents aged 12 and older who have COVID-19 but do not require hospitalization. The study focuses on participants who are at high risk of their illness becoming severe. This phase 3, double-blind trial randomly assigns eligible participants to receive either ibuzatrelvir or a placebo to compare outcomes while allowing standard care treatments. Participants will take ibuzatrelvir or a matching placebo orally every 12 hours for a total of 5 days. The study includes two groups: one receiving the active drug and the other receiving placebo tablets following the same schedule. The total participation period lasts about 6 months, during which researchers monitor health outcomes and adverse events. During the study, participants attend visits where their symptoms, viral loads from nasal or nasopharyngeal swabs, and medical events such as hospitalizations or emergency visits are assessed from the start through 24 weeks. The main outcome measured is the proportion of participants experiencing emergency department visits, hospitalizations, or death related to COVID-19 through 28 days. Safety is monitored continuously and symptom resolution and viral rebound are also tracked.

Researchers are evaluating the safety and effects of ritlecitinib, a medicine being studied for treating severe alopecia areata in children aged 6 to less than 12 years. Alopecia areata is a condition that causes significant hair loss on the scalp. This Phase 3 study aims to compare ritlecitinib to a placebo in pediatric participants with at least 50% scalp hair loss and prior varicella vaccination or infection, including some with a history of treatment failure in the EU/UK. Participants will be randomly assigned to one of three groups: a higher dose of ritlecitinib plus placebo, a lower dose of ritlecitinib plus placebo, or placebo only. All treatments are taken as oral capsules once daily at home for 24 weeks. This study will assess how ritlecitinib affects hair regrowth compared to placebo and will monitor safety, tolerability, and patient-centered outcomes. During the 6-month study, participants will have eight clinic visits and about eight phone calls to assess their progress. Evaluations will include scalp hair loss scores, eyebrow and eyelash assessments, patient-reported outcomes, and laboratory tests to measure drug levels and monitor safety. Those completing treatment may enter a long-term extension study or have a 4-week follow-up if they do not qualify for the extension.

This research aims to understand the safety and effects of a study medicine called PF-08653944 in adults who are overweight or obese and have type 2 diabetes. Type 2 diabetes is a condition where there is too much sugar in the blood, and being overweight means carrying excess body weight. The study is a phase 3, randomized, placebo-controlled trial sponsored by Pfizer to evaluate this medicine's impact on weight loss and diabetes management. Participants will receive the study medicine or a placebo via a shot under the skin in the belly area once every week. About 660 out of 1000 participants will get the study medicine while about 330 out of 1000 will receive a placebo, which looks like the medicine but contains no active drug. The study will last about 21 months and involve approximately 14 in-person visits and 5 phone visits. During the study, participants will be trained to self-inject the medicine at home. Researchers will monitor changes in body weight, blood sugar control (HbA1c), waist size, blood pressure, cholesterol levels, and quality of life through various tests and questionnaires at baseline and weeks 64 and 84. Safety will be tracked by recording any side effects or lab abnormalities. The main outcome is the percentage change in body weight from the start of the study to week 64.

Researchers are evaluating the effectiveness and safety of rimegepant for intermittent prevention of menstrual migraine in women who experience migraine attacks related to their menstrual cycles. This Phase 3, double-blind, randomized study focuses on women aged 18 to 45 years with a history of menstrual migraine. The study is sponsored by Pfizer and aims to compare rimegepant with placebo in reducing migraine days during the perimenstrual period. Participants will be assigned to receive either rimegepant 75 mg orally disintegrating tablets (ODT) for 7 consecutive days during the perimenstrual period or a matching placebo for the same duration. Additionally, rimegepant may be used for acute migraine treatment as needed, alongside a standard of care option for acute treatment. The study includes a 5-month double-blind treatment phase covering five menstrual cycles. During the study, participants will be monitored for changes in the number of migraine days and headache days during the 5-day perimenstrual period, as well as changes in the use of acute migraine medications. Assessments will also include migraine severity and functional disability, cognitive effects, and monthly migraine and headache days normalized to 28-day cycles. Safety and efficacy will be tracked throughout the study, which is expected to last through March 2027.

Researchers are evaluating how well active surveillance helps doctors monitor patients with low-risk germ cell tumors after surgical removal. The study also compares chemotherapy treatments using carboplatin versus cisplatin in pediatric, adolescent, and young adult patients with metastatic standard risk germ cell tumors. It aims to determine overall survival, event-free survival, and side effects such as hearing loss among these patients. The study includes patients with low-risk stage I ovarian immature teratoma or stage I non-seminoma or seminoma germ cell tumors who undergo observation. Patients with standard risk tumors are randomly assigned to receive one of four chemotherapy regimens combining bleomycin, etoposide, carboplatin, or cisplatin, given intravenously on specific days over cycles repeating every 21 days. Treatments continue for up to 3 or 4 cycles if no disease progression or unacceptable side effects occur. Throughout treatment and observation, patients undergo imaging scans, blood sample collection, tumor biopsies if needed, and pulmonary function tests. Participants will be followed with regular imaging and blood tests to monitor tumor response and recurrence, including CT, MRI, and chest x-rays. Follow-up visits occur every 2 months for the first year, then every 3 to 6 months through year 2, every 6 months for years 3 to 5, and annually up to 10 years. The study also assesses hearing outcomes, body composition, tumor marker decline, neuropathy, and serum microRNA over time to better understand treatment effects and patient quality of life.