Trial · NCT03041038

The Efficacy and Safety of Secukinumab in Patients With Ichthyoses

NCT03041038, Phase 2, Completed, Northwestern University; results first posted 2021-08-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Efficacy and Safety of Secukinumab in Patients With Ichthyoses. Trials, record NCT03041038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03041038

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Efficacy and Safety of Secukinumab in Patients With Ichthyoses
NCT number: NCT03041038
Status: Completed
Phases: Phase 2
Enrollment: 20 participants, actual
Lead sponsor: Northwestern University
Conditions: Ichthyosis, Autosomal Recessive Congenital Ichthyosis, Lamellar Ichthyosis, Congenital Ichthyosiform Erythroderma, Epidermolytic Ichthyosis, Netherton Syndrome
Interventions: Secukinumab, Placebo
First posted: 2017-02-02
Last updated: 2021-08-25
Results first posted: 2021-08-25

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Reduction at Week 16 in the Ichthyosis Area Severity Index (IASI)	16 Weeks	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.
Primary	Total Number of Bacterial or Fungal Mucocutaneous Infections Through Week 16	16 weeks of secukinumab/placebo double blind followed by 32 week open label treatment	Primary Safety Endpoint

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Reduction at Week 16 in the Ichthyosis Area Severity Index (IASI)	16 Weeks		units on a scale	MEAN
PRIMARY	Total Number of Bacterial or Fungal Mucocutaneous Infections Through Week 16	16 weeks of secukinumab/placebo double blind followed by 32 week open label treatment		infections	NUMBER

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Reduction at Week 16 in the Ichthyosis Area Severity Index (IASI)	Secukinumab	2.4	95% Confidence Interval -7.8 to 12.7	units on a scale
Reduction at Week 16 in the Ichthyosis Area Severity Index (IASI)	Placebo	4.3	95% Confidence Interval -6.5 to 15.1	units on a scale
Total Number of Bacterial or Fungal Mucocutaneous Infections Through Week 16	Secukinumab	5		infections
Total Number of Bacterial or Fungal Mucocutaneous Infections Through Week 16	Placebo	5		infections
Total Number of Bacterial or Fungal Mucocutaneous Infections Through Week 16	Open Label	10		infections

Source ClinicalTrials.gov

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Secukinumab	11
Overall Study	STARTED	Placebo	9
Overall Study	Week 16	Secukinumab	10
Overall Study	Week 16	Placebo	8
Overall Study	Week 32	Secukinumab	9
Overall Study	Week 32	Placebo	8
Overall Study	COMPLETED	Secukinumab	5
Overall Study	COMPLETED	Placebo	7
Overall Study	NOT COMPLETED	Secukinumab	6
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events27

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Bronchial infection	Infections and infestations	Secukinumab	0	11	0
other	Bronchial infection	Infections and infestations	Placebo	1	9	1
other	Bronchial infection	Infections and infestations	Open Label	0	18	0
other	Conjunctivitis	Infections and infestations	Secukinumab	1	11	1
other	Conjunctivitis	Infections and infestations	Placebo	0	9	0
other	Conjunctivitis	Infections and infestations	Open Label	0	18	0
other	Flu-like symptoms	Infections and infestations	Secukinumab	1	11	1
other	Flu-like symptoms	Infections and infestations	Placebo	0	9	0
other	Flu-like symptoms	Infections and infestations	Open Label	1	18	1
other	Otitis externa bacterial	Infections and infestations	Secukinumab	0	11	0

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Secukinumab	0	11
Total, all-cause mortality	Placebo	0	9
Total, all-cause mortality	Open Label	0	18
Total, other adverse events	Secukinumab	3	11
Total, other adverse events	Placebo	2	9
Total, other adverse events	Open Label	6	18
Total, serious adverse events	Secukinumab	1	11
Total, serious adverse events	Placebo	0	9
Total, serious adverse events	Open Label	1	18

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35218370	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03041038

GET https://conductscience.org/api/trials/v1/NCT03041038/events?page=2

API reference For AI assistants