A Phase 2 interventional study of Secukinumab and Placebo in Ichthyosis, Autosomal Recessive Congenital Ichthyosis and Lamellar Ichthyosis, sponsored by Northwestern University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-25.
Sponsored by Northwestern University · Phase 2, Interventional, and Treatment
The ichthyoses are a group of lifelong genetic disorders which share characteristics of generalized skin thickening, scaling and underlying cutaneous inflammation. There are no therapies based on growing understanding of what causes the disease. However, there have been recent discoveries of marked elevations in expression of interleukin-17A (IL-17A) and IL-17-related cytokines in the skin of individuals with ichthyosis, which may explain the inflammation. Investigators propose that IL-17-targeting therapeutics will safely suppress the inflammation and possibly the other features of ichthyosis, improving quality of life.
The ichthyoses are a group of lifelong genetic disorders which share characteristics of generalized skin thickening, scaling and underlying cutaneous inflammation. The vast majority are orphan disorders and are associated with extremely poor quality of life related to social ostracism from altered appearance, associated itchiness and discomfort, and functional limitations from the skin disease. Among the most common of these orphan disorders are autosomal recessive congenital ichthyosis (ARCI) with its phenotypic subsets of lamellar ichthyosis (ARCI-LI) and congenital ichthyosiform erythroderma (ARCI-CIE), epidermolytic ichthyosis (EI) and Netherton syndrome (NS). Therapy is time-consuming for patients or parents and is supportive, focusing on clearance of the scaling. There are no therapies based on growing understanding of what causes the disease. There have been recent discoveries of marked elevations in expression of interleukin-17A (IL-17A) and IL-17-related cytokines in the skin of individuals with ichthyosis, which may explain the inflammation. Psoriasis, another inflammatory skin disorder with redness and scaling, has now been shown to result from IL-17 pathway activation and IL-17A inhibition is the most effective therapy known to treat psoriasis. Investigators propose that IL-17-targeting therapeutics will safely suppress the inflammation and possibly the other features of ichthyosis, improving quality of life. In this long-term, open-label extension, Investigators propose to treat adults with ichthyosis and at least moderate erythema with subcutaneously administered anti-IL-17 antibody (secukinumab) and to serially assess clinical response to this therapy and its safety.
33 studies on the registry are indexed under Ichthyosis; 11 are open to participants now.
This study's enrollment of 20 is below the median of 26 across 23 interventional studies indexed under Ichthyosis.
Browse Ichthyosis studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial
Drug: Secukinumab
Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial
Drug: Placebo
Anti IL-17A antibody
Also known as: Cosentyx
Also known as: Sterile Saline
Reduction at Week 16 in the Ichthyosis Area Severity Index (IASI)
Primary Efficacy Endpoint. The IASI score was modelled after the Eczema Area and Severity Index (EASI) and Psoriasis Area and Severity Index (PASI), commonly used in clinical trials for atopic dermatitis and psoriasis, respectively. This scale measures erythema and scaling and has a range of 0-48 (sum of a max score of 24 for erythema and 24 for scaling). A higher score means worse clinical severity. Mean difference IASI total score at Baseline was compared to IASI total score at Week 16.
Time frame: 16 Weeks
Total Number of Bacterial or Fungal Mucocutaneous Infections Through Week 16
Primary Safety Endpoint
Time frame: 16 weeks of secukinumab/placebo double blind followed by 32 week open label treatment
| Milestone | Secukinumab | Placebo |
|---|---|---|
| Started | 11 | 9 |
| Week 16 | 10 | 8 |
| Week 32 | 9 | 8 |
| Completed | 5 | 7 |
| Not completed | 6 | 2 |
| Withdrew: Withdrawal by subject | 4 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Protocol violation | 1 | 1 |
Primary Efficacy Endpoint. The IASI score was modelled after the Eczema Area and Severity Index (EASI) and Psoriasis Area and Severity Index (PASI), commonly used in clinical trials for atopic dermatitis and psoriasis, respectively. This scale measures erythema and scaling and has a range of 0-48 (sum of a max score of 24 for erythema and 24 for scaling). A higher score means worse clinical severity. Mean difference IASI total score at Baseline was compared to IASI total score at Week 16.
| units on a scale | Secukinumab | Placebo |
|---|---|---|
| Reduction at Week 16 in the Ichthyosis Area Severity Index (IASI) | 2.4 (-7.8 to 12.7) | 4.3 (-6.5 to 15.1) |
Primary Safety Endpoint
| infections | Secukinumab | Placebo | Open Label |
|---|---|---|---|
| Total Number of Bacterial or Fungal Mucocutaneous Infections Through Week 16 | 5 | 5 | 10 |
Collected over 56 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Secukinumab | 0/11 (0%) | 1/11 (9.1%) | 3/11 (27.3%) |
| Placebo | 0/9 (0%) | 0/9 (0%) | 2/9 (22.2%) |
| Open Label | 0/18 (0%) | 1/18 (5.6%) | 6/18 (33.3%) |
| Event | Secukinumab | Placebo | Open Label |
|---|---|---|---|
| Hospitalization-GERDGastrointestinal disorders | 1/11 | 0/9 | 1/18 |
| Hospitalization-pyelonephritisInfections and infestations | 0/11 | 0/9 | 1/18 |
| Event | Secukinumab | Placebo | Open Label |
|---|---|---|---|
| Skin InfectionInfections and infestations | 0/11 | 0/9 | 3/18 |
| Bronchial infectionInfections and infestations | 0/11 | 1/9 | 0/18 |
| Upper Respiratory InfectionInfections and infestations | 1/11 | 1/9 | 1/18 |
| Urinary tract infectionInfections and infestations | 0/11 | 1/9 | 2/18 |
| ConjunctivitisInfections and infestations | 1/11 | 0/9 | 0/18 |
| Flu-like symptomsInfections and infestations | 1/11 | 0/9 | 1/18 |
| Otitis externa bacterialInfections and infestations | 0/11 | 0/9 | 1/18 |
| Age, Continuous(years) | Secukinumab | Placebo | Total |
|---|---|---|---|
| Mean | 34.2 ± 11.7 | 35.5 ± 12.7 | 34.7 ± 12.9 |
| Sex: Female, Male(Participants) | Secukinumab | Placebo | Total |
|---|---|---|---|
| Female | 8 | 4 | 12 |
| Male | 3 | 5 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Secukinumab | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 10 | 8 | 18 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Secukinumab | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 9 | 8 | 17 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Ichthyosis Subtype(Participants) | Secukinumab | Placebo | Total |
|---|---|---|---|
| CIE | 3 | 2 | 5 |
| EI | 2 | 2 | 4 |
| LI | 4 | 2 | 6 |
| NS | 2 | 3 | 5 |
| Site(Participants) | Secukinumab | Placebo | Total |
|---|---|---|---|
| Mount Sinai | 4 | 2 | 6 |
| Northwestern | 7 | 7 | 14 |
| Weight(kilograms) | Secukinumab | Placebo | Total |
|---|---|---|---|
| Mean | 69.9 ± 13.5 | 75.5 ± 30.4 | 72.4 ± 22.0 |
| Ichthyosis Area Severity Index (IASI)(units on a scale) | Secukinumab | Placebo | Total |
|---|---|---|---|
| Mean | 33.7 ± 6.5 | 36.2 ± 4.7 | 34.8 ± 5.9 |
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Secukinumab