Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Atopic Dermatitis
NCT ID: NCT03245385
Last Updated: 2019-09-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
TERMINATED
Clinical Phase
PHASE2
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-07-24
Study Completion Date
2018-02-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and potential for adrenal suppression following topical treatment with halobetasol propionate 0.05% spray applied twice-daily in adult patients with moderate to severe atopic dermatitis. At least 40 eligible patients with atopic dermatitis that satisfy all eligibility criteria will be enrolled into the study
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
NCT03847389
Atopic Dermatitis
TERMINATED
PHASE1/PHASE2
A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis
NCT03431610
Atopic Dermatitis
COMPLETED
PHASE1
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
NCT01756898
Atopic Dermatitis
COMPLETED
PHASE2
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Atopic Dermatitis
NCT02595008
Dermatitis, Atopic
COMPLETED
PHASE2
Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
NCT04875169
Atopic Dermatitis
COMPLETED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and potential for adrenal suppression following topical treatment with halobetasol propionate 0.05% spray applied twice-daily in adult patients with moderate to severe atopic dermatitis. At least 40 eligible patients with atopic dermatitis that satisfy all eligibility criteria will be enrolled into the study. Patients must be overall in good health and should have a current diagnosis of moderate to severe atopic dermatitis with Investigator Global Assessment (IGA) score of at least 3 or 4. Patients will be stratified by age with:
Cohort 1: At least 20 patients 18 years of age and older with ≥ 25% BSA affected.
Cohort 2: At least 20 patients 12-16 years and 11 months of age with ≥ 25% BSA affected.
Cohort 2 will initiate enrollment once all enrolled patients in Cohort 1 have completed the study and a safety analysis has been reviewed by the Medical Monitor and approved by the Novum Independent Institutional Review Board (NIIRB). Sites will not begin enrollment of patients in Cohort 2 until the site is notified by email that the safety analysis for Cohort 1 has been reviewed and approved. Each cohort will be enrolled based on the availability of patients. Each cohort will be reviewed for the potential of HPA axis suppression. The Medical Monitor or NIIRB may discontinue the study at any time if safety concerns are found. If 6 or more patients in Cohort 1 experience HPA axis suppression, then enrollment for Cohort 1 will be stopped. Cohort 2 will not be initiated if 6 or more patients enrolled in Cohort 1 experience HPA axis suppression or 30% or more of the final enrolled number of patients in Cohort 1 experience HPA axis suppression. If 6 or more patients in Cohort 2 experience HPA axis suppression, then enrollment for Cohort 2 will be stopped. If the study is stopped at any time, patients currently enrolled will be contacted via phone and instructed to discontinue study product immediately. Patients will be instructed to return for their next scheduled visit for cortisol response testing. Sites will follow up with patients and monitor for HPA axis suppression. All patients will be followed until cortisol levels are normal, as defined in study protocol. Patients enrolled in the study will apply the study product twice daily onto the affected skin areas for 14 days (Days 1-14), according to provided instructions. .Patients will be instructed not to rub over the affected area after application of spray. Each patient is expected to receive 28 doses of study product. All patients will attend the clinic for the following 8 scheduled visits. Patients will apply the morning dose of the study product in the clinic at each clinic visit (and evening dose on Day 4) and at home during non-clinic visits. A phone call will be made approximately 14 days after the patient has completed dosing to follow-up on any new adverse events that may have occurred. All patients will have a cortisol response test performed at screening and on Day 17 (at least 48 hours after last dose of study product).
The safety profile of the test product will be evaluated by analysis of reported adverse events.
Cohort 1: At least 20 patients 18 years of age and older with ≥ 25% BSA affected.
Cohort 2: At least 20 patients 12-16 years and 11 months of age with ≥ 25% BSA affected.
Cohort 2 will initiate enrollment once all enrolled patients in Cohort 1 have completed the study and a safety analysis has been reviewed by the Medical Monitor and approved by the Novum Independent Institutional Review Board (NIIRB). Sites will not begin enrollment of patients in Cohort 2 until the site is notified by email that the safety analysis for Cohort 1 has been reviewed and approved. Each cohort will be enrolled based on the availability of patients. Each cohort will be reviewed for the potential of HPA axis suppression. The Medical Monitor or NIIRB may discontinue the study at any time if safety concerns are found. If 6 or more patients in Cohort 1 experience HPA axis suppression, then enrollment for Cohort 1 will be stopped. Cohort 2 will not be initiated if 6 or more patients enrolled in Cohort 1 experience HPA axis suppression or 30% or more of the final enrolled number of patients in Cohort 1 experience HPA axis suppression. If 6 or more patients in Cohort 2 experience HPA axis suppression, then enrollment for Cohort 2 will be stopped. If the study is stopped at any time, patients currently enrolled will be contacted via phone and instructed to discontinue study product immediately. Patients will be instructed to return for their next scheduled visit for cortisol response testing. Sites will follow up with patients and monitor for HPA axis suppression. All patients will be followed until cortisol levels are normal, as defined in study protocol. Patients enrolled in the study will apply the study product twice daily onto the affected skin areas for 14 days (Days 1-14), according to provided instructions. .Patients will be instructed not to rub over the affected area after application of spray. Each patient is expected to receive 28 doses of study product. All patients will attend the clinic for the following 8 scheduled visits. Patients will apply the morning dose of the study product in the clinic at each clinic visit (and evening dose on Day 4) and at home during non-clinic visits. A phone call will be made approximately 14 days after the patient has completed dosing to follow-up on any new adverse events that may have occurred. All patients will have a cortisol response test performed at screening and on Day 17 (at least 48 hours after last dose of study product).
The safety profile of the test product will be evaluated by analysis of reported adverse events.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Atopic Dermatitis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Open label, single treatment arm study
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment with topical halobetasol spray 0.05%
Patients will instructed o apply halobetasol spray twice daily for 14 days and not to rub over the affected area after application of spray.
Group Type
EXPERIMENTAL
Treatment with Halobetasol propionate 0.05% topical spray
Intervention Type
DRUG
Patients will be treated with topical halobetasol 0.05% spray applied twice daily for 14 days. Patients will be instructed not to rub over the affected area after application of spray. Each patient is expected to receive 28 doses. The maximum amount of test product applied per week will not exceed 50 g
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Treatment with Halobetasol propionate 0.05% topical spray
Patients will be treated with topical halobetasol 0.05% spray applied twice daily for 14 days. Patients will be instructed not to rub over the affected area after application of spray. Each patient is expected to receive 28 doses. The maximum amount of test product applied per week will not exceed 50 g
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Males or non-pregnant, non-lactating females:
* Cohort 1: 18 years of age and older
* Cohort 2: 12-16 years and 11 months of age (Cohort 2 will not begin enrollment until review and approval of safety information from Cohort 1.)
2. If female and of childbearing potential, prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, transdermal or injected hormonal contraceptives). Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before baseline and should not change this regimen during the study.
3. Signed informed consent form that meets all criteria of current FDA regulations. For a patient considered to be a minor in the state he/she lives and is enrolled, the parent or legal guardian will be required to sign the consent form and the patient will sign an IRB approved "assent to participate" form. Approved informed consent and assent forms specific to each cohort will be required.
4. Patients with a definite clinical diagnosis of moderate to severe atopic dermatitis with ≥ 25% BSA affected (excluding face, scalp, groin, axillae and other intertriginous areas)
5. Investigator Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe).
6. Patients in Cohort 2 must weigh a minimum of 26 kg.
7. Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response. Patients must fulfill all of the following stipulations:
1. Basal (pre Cortrosyn™ injection) cortisol concentration ≥ 5 mcg/100 mL.
2. 30-minute post-injection cortisol level is at least 7 mcg/100 mL greater than the basal level (≥ basal value + 7).
3. Post-stimulation level \> 18 mcg/100 mL.
* Cohort 1: 18 years of age and older
* Cohort 2: 12-16 years and 11 months of age (Cohort 2 will not begin enrollment until review and approval of safety information from Cohort 1.)
2. If female and of childbearing potential, prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, transdermal or injected hormonal contraceptives). Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before baseline and should not change this regimen during the study.
3. Signed informed consent form that meets all criteria of current FDA regulations. For a patient considered to be a minor in the state he/she lives and is enrolled, the parent or legal guardian will be required to sign the consent form and the patient will sign an IRB approved "assent to participate" form. Approved informed consent and assent forms specific to each cohort will be required.
4. Patients with a definite clinical diagnosis of moderate to severe atopic dermatitis with ≥ 25% BSA affected (excluding face, scalp, groin, axillae and other intertriginous areas)
5. Investigator Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe).
6. Patients in Cohort 2 must weigh a minimum of 26 kg.
7. Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response. Patients must fulfill all of the following stipulations:
1. Basal (pre Cortrosyn™ injection) cortisol concentration ≥ 5 mcg/100 mL.
2. 30-minute post-injection cortisol level is at least 7 mcg/100 mL greater than the basal level (≥ basal value + 7).
3. Post-stimulation level \> 18 mcg/100 mL.
Exclusion Criteria
1. Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of childbearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.
2. Mild atopic dermatitis.
3. IGA score \< 3.
4. Atopic dermatitis with a BSA involvement \< 25%.
5. Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response:
1. Basal (pre CortrosynTM injection) cortisol concentration \< 5 mcg/100 mL.
2. 30 minute post-injection cortisol level is less than 7 mcg/100 mL greater than the basal level (\< basal value + 7).
3. Post-stimulation level ≤ 18 mcg/100 mL.
6. Recurrent or active cutaneous bacterial or viral infection in any treatment area at baseline (i.e., clinically infected atopic dermatitis).
7. Patient has a history of atopic dermatitis that has been unresponsive to topical corticosteroid therapy.
8. Any condition (i.e., sunburn, psoriasis etc.) that, in the Investigator's opinion, may interfere with the clinical assessments of the signs and symptoms of atopic dermatitis.
9. History of prolonged bleeding or a past diagnosis of bleeding disorders and/or history of blood loss exceeding 450 mL (including blood donations) within 1 month before the study.
10. Patient with poor peripheral venous access.
11. History of mastectomy or lymphatic insufficiency of the upper limb (patient is eligible if blood can be taken from the arm opposite the site of surgery or condition).
12. History of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.
13. Patient has a significant history or current evidence of chronic infectious disease, system disorder, Netherton's Syndrome, uncontrolled diabetes, organ disorder or insufficiency, immunosuppression (from medical treatment or disease) or other medical condition that, in the Investigator's opinion, would place the study patient at undue risk by participation in the study or as an unsuitable candidate for pharmacokinetic blood sampling.
14. Patient is currently receiving or has received any radiation therapy or anti-neoplastic agents within 3 months before baseline.
15. Use within 4 weeks before baseline of 1) oral or intravenous corticosteroids, 2) UVA/UVB therapy, 3) PUVA (psoralen plus ultraviolet A therapy, 4) topical tacrolimus, 5) topical pimecrolimus, 6) systemic retinoids or 7) any other systemic atopic dermatitis treatment.
16. Known history of hypothalamic-pituitary-adrenal axis impairment or any other disturbance of the adrenal function (e.g., Cushing or Addison disease).
17. Use of tanning booths or nonprescription UV light source within 2 weeks before baseline.
18. Use within 8 weeks before baseline of 1) immunomodulators or immunosuppressive therapies or 2) interferon.
19. Use within 14 days before baseline of 1) systemic antibiotics, 2) calcipotriene or other Vitamin D preparations, or 3) topical retinoids.
20. Patients who have used topical treatments, prescription or over the counter, including:
1. Any topical atopic dermatitis therapeutic agents of any kind within the 2 weeks before baseline.
2. Any topical corticosteroids within the 2 weeks before baseline.
3. Any antibacterial, medicated and/or astringent washes, soaps, pads or moisturizers within 3 days before baseline.
4. High strength (20% or above) alpha-hydroxy acid or any kind of peel or other procedures (e.g., laser hair removal) within 30 days before baseline.
5. Any topical products (i.e., sunscreens, lotions, creams), except for bland emollient (moisturizer) within 24 hour before baseline.
6. Topical antibiotics in the treatment area within 7 days before baseline.
21. Patient has been treated within 6 months before baseline with any biological therapies for atopic dermatitis.
22. Inability to understand the protocol requirements, instructions, and study-related restrictions, the nature, scope, and possible consequences of the clinical study.
23. Unlikely to comply with the protocol requirements, instructions, and study-related restrictions, such as uncooperative attitude, inability to return for follow-up visits, and improbability of completing the clinical study.
24. Receipt of any drug as part of a research study within 30 days before baseline.
25. The patient is a member of the investigational study staff or a member of the family of the investigational study staff.
26. Previous participation in this study.
2. Mild atopic dermatitis.
3. IGA score \< 3.
4. Atopic dermatitis with a BSA involvement \< 25%.
5. Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response:
1. Basal (pre CortrosynTM injection) cortisol concentration \< 5 mcg/100 mL.
2. 30 minute post-injection cortisol level is less than 7 mcg/100 mL greater than the basal level (\< basal value + 7).
3. Post-stimulation level ≤ 18 mcg/100 mL.
6. Recurrent or active cutaneous bacterial or viral infection in any treatment area at baseline (i.e., clinically infected atopic dermatitis).
7. Patient has a history of atopic dermatitis that has been unresponsive to topical corticosteroid therapy.
8. Any condition (i.e., sunburn, psoriasis etc.) that, in the Investigator's opinion, may interfere with the clinical assessments of the signs and symptoms of atopic dermatitis.
9. History of prolonged bleeding or a past diagnosis of bleeding disorders and/or history of blood loss exceeding 450 mL (including blood donations) within 1 month before the study.
10. Patient with poor peripheral venous access.
11. History of mastectomy or lymphatic insufficiency of the upper limb (patient is eligible if blood can be taken from the arm opposite the site of surgery or condition).
12. History of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.
13. Patient has a significant history or current evidence of chronic infectious disease, system disorder, Netherton's Syndrome, uncontrolled diabetes, organ disorder or insufficiency, immunosuppression (from medical treatment or disease) or other medical condition that, in the Investigator's opinion, would place the study patient at undue risk by participation in the study or as an unsuitable candidate for pharmacokinetic blood sampling.
14. Patient is currently receiving or has received any radiation therapy or anti-neoplastic agents within 3 months before baseline.
15. Use within 4 weeks before baseline of 1) oral or intravenous corticosteroids, 2) UVA/UVB therapy, 3) PUVA (psoralen plus ultraviolet A therapy, 4) topical tacrolimus, 5) topical pimecrolimus, 6) systemic retinoids or 7) any other systemic atopic dermatitis treatment.
16. Known history of hypothalamic-pituitary-adrenal axis impairment or any other disturbance of the adrenal function (e.g., Cushing or Addison disease).
17. Use of tanning booths or nonprescription UV light source within 2 weeks before baseline.
18. Use within 8 weeks before baseline of 1) immunomodulators or immunosuppressive therapies or 2) interferon.
19. Use within 14 days before baseline of 1) systemic antibiotics, 2) calcipotriene or other Vitamin D preparations, or 3) topical retinoids.
20. Patients who have used topical treatments, prescription or over the counter, including:
1. Any topical atopic dermatitis therapeutic agents of any kind within the 2 weeks before baseline.
2. Any topical corticosteroids within the 2 weeks before baseline.
3. Any antibacterial, medicated and/or astringent washes, soaps, pads or moisturizers within 3 days before baseline.
4. High strength (20% or above) alpha-hydroxy acid or any kind of peel or other procedures (e.g., laser hair removal) within 30 days before baseline.
5. Any topical products (i.e., sunscreens, lotions, creams), except for bland emollient (moisturizer) within 24 hour before baseline.
6. Topical antibiotics in the treatment area within 7 days before baseline.
21. Patient has been treated within 6 months before baseline with any biological therapies for atopic dermatitis.
22. Inability to understand the protocol requirements, instructions, and study-related restrictions, the nature, scope, and possible consequences of the clinical study.
23. Unlikely to comply with the protocol requirements, instructions, and study-related restrictions, such as uncooperative attitude, inability to return for follow-up visits, and improbability of completing the clinical study.
24. Receipt of any drug as part of a research study within 30 days before baseline.
25. The patient is a member of the investigational study staff or a member of the family of the investigational study staff.
26. Previous participation in this study.
Minimum Eligible Age
12 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novum Pharmaceutical Research Services
INDUSTRY
Sponsor Role
collaborator
Sun Pharmaceutical Industries Limited
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rajinder K Jalali, MD
Role: STUDY_DIRECTOR
Sun Pharmaceutical Industries Limited
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Providence Clinical Research
North Hollywood, California, United States
Site Status
Havana Research Institute
Pasadena, California, United States
Site Status
Vital Pharma Research
Hialeah, Florida, United States
Site Status
Solutions Through Advanced Research
Jacksonville, Florida, United States
Site Status
Integrity Research Center
Miami, Florida, United States
Site Status
Millennium Clinical Research, INC
Miami, Florida, United States
Site Status
Regenerate Clinical Trials, LLC
Miami, Florida, United States
Site Status
Life Medical Center and Research, INC
Miami, Florida, United States
Site Status
Vista Health Research
Miami, Florida, United States
Site Status
Elias Research
Troy, Michigan, United States
Site Status
Montana Medical Research/Elias Research Assoc.
Missoula, Montana, United States
Site Status
L&C Professional Medical Research Institute
Hazleton, Pennsylvania, United States
Site Status
Sun Research Institute
San Antonio, Texas, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
71542613
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis
NCT01232543
COMPLETED
PHASE2
Delgocitinib Cream for the Treatment of Moderate to Severe Atopic Dermatitis During 8 Weeks in Adults, Adolescents, and Children
NCT03826901
COMPLETED
PHASE1
Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
NCT03422822
COMPLETED
PHASE3
A Multi-Center Study of Short and Long-term Use of Protopic Ointment in Patients With Atopic Dermatitis
NCT00106496
COMPLETED
PHASE4
A Study to Evaluate the Safety and Tolerability of MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Participants With Moderate to Severe Atopic Dermatitis
NCT03864627
TERMINATED
PHASE2
Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis
NCT00125333
COMPLETED
PHASE1/PHASE2
Study of 0417 Ointment in the Treatment of Atopic Dermatitis
NCT01139450
COMPLETED
PHASE3
Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)
NCT03345914
COMPLETED
PHASE3
Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
NCT04345367
COMPLETED
PHASE3
A Phase 1/2 Study of E6005 in Pediatric Subjects With Atopic Dermatitis
NCT02094235
COMPLETED
PHASE1/PHASE2
A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema
NCT06807268
RECRUITING
PHASE3
A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 2 Doses of S-777469 in Patients With Atopic Dermatitis
NCT00703573
COMPLETED
PHASE2
Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis
NCT03903822
COMPLETED
PHASE2
A Study to Test Safety, Tolerability, and the Way the Body Absorbs, Distributes, and Gets Rid of a Study Drug Called MOR106, in Healthy Subjects and in Patients With Moderate to Severe Atopic Dermatitis
NCT03689829
TERMINATED
PHASE1
This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)
NCT05608343
COMPLETED
PHASE3
Study Comparing Product 0405 to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects
NCT02176538
WITHDRAWN
PHASE3
Effect of OC000459 on Moderate to Severe Atopic Dermatitis
NCT02002208
COMPLETED
PHASE2
A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis
NCT04090229
COMPLETED
PHASE1
Phase 2a Study of the Safety, Tolerability, and Pharmacokinetics of Topically Administered PRN473 (SAR444727) in Patients With Mild to Moderate Atopic Dermatitis
NCT04992546
COMPLETED
PHASE2
Study to Determine the Pharmacokinetics of Product 0405
NCT02176577
WITHDRAWN
PHASE3
A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic Dermatitis
NCT04643457
COMPLETED
PHASE1/PHASE2
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis
NCT03747575
COMPLETED
PHASE2
A Study of AK120 (IL-4Rα) in Healthy Subjects and Subjects With Moderate- to- Severe Atopic Dermatitis
NCT04256174
COMPLETED
PHASE1
Distribution of Tacrolimus in Skin, Atopic Dermatitis
NCT00534508
COMPLETED
PHASE2
Observational Evaluation of Atopic Dermatitis in Pediatric Patients
NCT03687359
ACTIVE_NOT_RECRUITING