- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04549792
An Open-Label and Long-Term Extension Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Patients With Ichthyoses
An Open-Label and Long-Term Extension Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Patients With Ichthyoses.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: NU Dermatology CTU
- Phone Number: 312-503-5944
- Email: NUderm-research@northwestern.edu
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University/Lurie Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subject has provided informed consent; parental consent for patients under 18 years of age (plus assent for subjects age ≥ 12 and < 18).
- Subjects are at least 6 years of age or older at the time of screening.
Before screening visit, females must be:
Postmenopausal, defined as
≥ 45 years of age with amenorrhea for at least 18 months, OR
- ≥ 45 years of age with amenorrhea for at least 6 months and a serum FSH level > 40 IU/mL OR
- Of childbearing potential, in which case she must satisfy at least one of the below:
Surgically sterile (has had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
If heterosexually active, practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (e.g., condoms, diaphragm, or cervical cap, with spermicidal foam, cream, film, gel or suppository), or male partner sterilization, consistent with local regulations regarding use of birth control methods for subjects participating in clinical trials, for a period of 16 weeks after the last administration of study agent,
OR
Not heterosexually active. Abstinence is allowed as an acceptable form of contraception.
Note: If a woman participant's childbearing potential changes after start of the study (e.g., a premenarchal woman experiences menarche) or if women of childbearing potential who are not heterosexually active at screening become heterosexually active, they must agree to utilize a highly effective method of birth control, as described above.
Female participants of childbearing potential (menstrual and not surgically sterile), must have a negative serum beta-human chorionic gonadotropin (ᵦ-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 (prior to screening visit) and agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 16 weeks after the last administration of study agent.
• Male participants who are not surgically sterilized and are heterosexually active with a woman of childbearing potential, must agree to use a barrier method of contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository) and to not donate sperm during the study and for 16 weeks after last receiving study agent. Note that barrier methods must also be used in all male subjects sexually active with pregnant partners for at least 16 weeks after last study agent administration.
- Subjects must have a confirmed clinical diagnosis of ichthyosis/ichthyotic disorder, and either have completed genotype or be willing to be genotyped (genotype results will not be required for entry into the study).
- Subjects must have at least moderate erythema (ISS-erythema score ≥ 2) related to his/her ichthyosis/ichthyotic disorder.
- Subjects must be clinically judged to be immunocompetent based on baseline laboratory testing (chemistry and hematology), medical history and physical examination.
- Subjects will have baseline negative QuantiFERON®-TB gold, Hepatitis B, Hepatitis C, and HIV laboratory testing.
Exclusion Criteria:
- Subjects who are unable to provide informed consent or assent (or who do not have consent from a Legally Authorized Representative if < 18 years).
- Subjects with ichthyosis vulgaris or X-linked recessive ichthyosis.
- Subjects who have a known allergy to ustekinumab or its products.
- Female subjects who are pregnant or breastfeeding, or who are considering becoming pregnant.
- Subjects who have prior biologic use targeting IL-12/IL-23 monoclonal antibody.
- Subjects who have used a systemic retinoid or systemic anti-inflammatory agent within 4 weeks prior to baseline.
- Subjects who have used topical steroid in the previous week, retinoid or keratolytic agent in the previous 24 hours.
- Subjects with active infections or recent history of serious infections, malignancies or history of malignancies, recent immunizations with live vaccines, or any severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral disease, or signs or symptoms thereof
- Subjects who are under 6 years of age at the time of screening.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Open Label
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Each subject will receive ustekinumab at Baseline (Day 0) and Months 1, 3, 5, 7, 9, and 11.
During the LTE, subjects will receive injections every 8 weeks for one year: Month 13, Month 15, Month 17, Month 19, Month 21, and Month 23.
Subjects will come back in for a follow-up visit at Month 25 for an end of study visit (no drug administration).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in Ichthyosis Severity Score
Time Frame: 7 months after initiation of study drug
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To evaluate the efficacy of ustekinumab for ichthyosis, as measured by an at least 50% reduction in severity (using the Ichthyosis Severity Score (ISS) measure
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7 months after initiation of study drug
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Occurence of bacterial and fungal infections
Time Frame: 7 months after initiation of study drug
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To evaluate the safety of ustekinumab for ichthyosis, based on occurrence of bacterial and fungal infections
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7 months after initiation of study drug
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amy Paller, MD, Northwestern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-3233
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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