A Phase 2 interventional study of KB105 and Placebo in Autosomal Recessive Ichthyosis, sponsored by Krystal Biotech, Inc.. Status unknown at 1 site in United States. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2023-02-23.
Sponsored by Krystal Biotech, Inc. · Phase 2, Interventional, and Treatment
KB105-02 is an intrasubject randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KB105 in children and adults with autosomal recessive congenital ichthyosis (ARCI).
33 studies on the registry are indexed under Ichthyosis; 11 are open to participants now.
This study's planned enrollment of 15 is below the median of 26 across 23 interventional studies indexed under Ichthyosis.
Browse Ichthyosis studies →Krystal Biotech, Inc. is the lead sponsor of 18 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weekly topical application
Biological: KB105
Weekly topical application
Other: Placebo
Replication-defective, non-integrating HSV-1 vector expressing TGM1 formulated as a topical gel
Visually matched excipient gel
Composite Investigator's Global Assessment (IGA) Responder (Comparison of proportion of responder KB105 target areas to responder placebo target areas)
Responder target areas are defined as: Target areas with ≥2 point reduction from baseline on IGA scaling severity at Week 9 or Target areas with ≥1 point reduction from baseline on IGA scaling severity for 2 consecutive weeks (Week 8 and Week 9)
Time frame: Week 9
Composite regional Visual Index of Ichthyosis Severity (VIIS) responder (Comparison of proportion of responder KB105 target areas to responder placebo target areas)
Responder target areas are defined as: Target areas with ≥2 point reduction from baseline on VIIS scaling score at Week 9 or Target areas with ≥1 point reduction from baseline on VIIS scaling score for 2 consecutive weeks (Week 8 and Week 9)
Time frame: Week 9
Visual Index of Ichthyosis Severity score change from baseline
Change from baseline in regional Visual Index of Ichthyosis Severity (VIIS) scaling scores, where 0 is normal and 4 is severe
Time frame: Up to 11 weeks
Investigator's Global Assessment change from baseline
Change from baseline in Investigator's Global Assessment (IGA) scaling severity scores, where 0 is clear and 4 is severe
Time frame: Up to 11 weeks
Investigator's Global Assessment (IGA) 2 point responder
Comparison of proportion of KB105 and placebo target areas with ≥2 point reduction from baseline on IGA scaling severity at Week 9
Time frame: Week 9
Investigator's Global Assessment (IGA) 1 point responder
Comparison of proportion of KB105 and placebo target areas with ≥1 point reduction from baseline on IGA scaling severity for 2 consecutive weeks (Week 8 and Week 9)
Time frame: Week 9
Visual Index of Ichthyosis Severity (VIIS) 2 point responder
Comparison of proportion of KB105 and placebo target areas with ≥2 point reduction from baseline on regional VIIS scaling severity at Week 9
Time frame: Week 9
Visual Index of Ichthyosis Severity (VIIS) 2 point responder
Comparison of proportion of KB105 and placebo target areas with ≥1 point reduction from baseline on regional VIIS scaling severity for 2 consecutive weeks (Week 8 and Week 9)
Time frame: Week 9
Start is estimated for Mar 2023; primary completion for Mar 2024, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Krystal Biotech, Inc.