NCT03131570

Safety and Efficacy of Secukinumab in Mild Psoriasis

Completed Phase 2 Results posted Last updated 21 October 2022

What this trial tests

Phase 2 trial testing Secukinumab in Psoriasis in 23 participants. Completed in 21 June 2021.

Timeline

23 May 2017

Primary endpoint
8 January 2020

21 June 2021

Quick facts

Lead sponsor	James G. Krueger, MD, PhD
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	23
Start date	23 May 2017
Primary completion	8 January 2020
Estimated completion	21 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Secukinumab (secukinumab) — full drug profile →
• Placebo followed by Secukinumab — full drug profile →

Conditions studied

• Psoriasis — all drugs for Psoriasis →

Sponsor

James G. Krueger, MD, PhD — full company profile →

Who can join

18 and older, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Subjects Who Have 75% or More Reduction in [Psoriasis Area-and-severity Index Score (PASI)] (PASI75) Primary · week 12

The percentage of subjects who have a reduction of 75% or more from baseline in the Psoriasis Area and Severity Index (PASI) at week 12 (PASI 75). Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)

Group	Value	95% CI
Group 1	8
Group 2	0

Percentage of Subjects Who Have 90% or More Reduction in [Psoriasis Area-and-severity Index Score (PASI)] (PASI90) Secondary · week 12

The percentage of subjects who have a reduction of 90% or more from baseline in the Psoriasis Area and Severity Index (PASI) at week 12 (PASI 90). Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)

Group	Value	95% CI
Group 1	7
Group 2	0

Percentage of Subjects Who Achieve a Physician Global Assessment (PGA) Score of 0 or 1 With at Least a 2-step Improvement From Baseline (PGA 0/1 Response Rate). Secondary · week 12

Percentage of Subjects Who Achieve a Physician Global Assessment (PGA) score of 0 or 1 with at least a 2-step improvement from baseline (PGA 0/1 response rate). Physician Global Assessment (PGA) is a global assessment of all psoriasis lesions scored on a scale of 0-5, with 0 representing clear skin, 1 almost clear skin, and 5 representing severe psoriasis

Group	Value	95% CI
Group 1	9
Group 2	0

Percentage of Subjects Who Experience Psoriasis Relapse Secondary · week 24 through week 72

The percentage of subjects who experience a psoriasis relapse at any time between week 24 and week 72. Psoriasis relapse is defined as loss of \> 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at week 24. Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)

Group	Value	95% CI
Secukinumab Only	3
Placebo Then Secukinumab	2

Percentage of Subjects Who Experience Severe Psoriasis Relapse Secondary · Observation Period: week 24 through week 72.

The percentage of subjects who experience a severe psoriasis relapse at any time between week 24 and week 72. Severe psoriasis relapse is defined as loss of \> 75% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at week 24. Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)

Group	Value	95% CI
Secukinumab Only	2
Placebo Then Secukinumab	1

Percentage of Subjects Who Experience Psoriasis Relapse After Psoriasis is Cleared Secondary · Observation Period: week 24 through week 72

The percentage of subjects who experience a psoriasis relapse at any time between week 24 and week 72 among the subjects whose psoriasis is cleared between week 0 and week 24. Psoriasis relapse is defined as loss of \> 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at week 24. Psoriasis clearance is defined as the achievement of PASI100, which is a reduction of 100% from baseline in the Psoriasis Area and Severity Index (PASI) score. Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single

Group	Value	95% CI
Secukinumab Only	1
Placebo Then Secukinumab	1

Elapsed Time Until Relapse Secondary · week 24 until week 72

Elapsed time from week 24 until relapse occurs before week 72, measured in weeks.

Group	Value	95% CI
Secukinumab Only	24	18 – 24
Placebo Then Secukinumab	48	48 – 48

Percentage of Subjects Who Have 100% Reduction in [Psoriasis Area-and-severity Index Score (PASI)] (PASI100) Secondary · week 12

The percentage of subjects who have a reduction of 100% from baseline in the Psoriasis Area and Severity Index (PASI) score (PASI100) at week 12. Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)

Group	Value	95% CI
Group 1	4
Group 2	0

Frequency of Adverse Events Secondary · week 0 through week 72

Frequency of all Adverse Events (AEs) including Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to comorbidities, such as hypertension, diabetes, and cardiovascular diseases).

Group	Value	95% CI
Secukinumab Only	22
Placebo Then Secukinumab	13

Frequency of Serious Adverse Events Secondary · week 0 through week 72

Frequency of Serious Adverse Events (SAEs) that occur during the whole trial including the observational period.

Group	Value	95% CI
Secukinumab Only	1
Placebo Then Secukinumab	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1

Serious: 1/12 (8%)

Deaths: 0/12

Group 2

Serious: 0/11 (0%)

Deaths: 0/11

Serious adverse events (1 terms)

Reaction	System	Group 1	Group 2
Acute coronary syndrome	Cardiac disorders	—	—

Other adverse events (22 terms — click to expand)

Reaction	System	Group 1	Group 2
upper respiratory infection	Infections and infestations	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Sore throat	Respiratory, thoracic and mediastinal disorders	—	—
eye disorders- blepheritis	Eye disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Gastroesophageal reflux disease	Gastrointestinal disorders	—	—
Gingival pain	Gastrointestinal disorders	—	—
Flu like symptoms	General disorders	—	—
Fatigue	General disorders	—	—
Non-cardiac chest pain	General disorders	—	—
allergic reaction	Immune system disorders	—	—
tooth infection	Infections and infestations	—	—
Fall	Injury, poisoning and procedural complications	—	—
Fracture	Injury, poisoning and procedural complications	—	—
Blood bilirubin increased	Investigations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Neoplasms benig, malignant and unspecified (incl cysts and polyps), other: breast cyst	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Headache	Nervous system disorders	—	—
Pruritis	Skin and subcutaneous tissue disorders	—	—
Rash maculopapular	Skin and subcutaneous tissue disorders	—	—
skin and subcutaneous tissue disorders, other: folliculitis	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Acute coronary syndrome.

Data from ClinicalTrials.gov NCT03131570 adverse events section.

Sponsor's own description

Mild psoriasis not only progresses to moderate-to-severe psoriasis but also precedes systemic inflammation that leads to psoriatic arthritis and cardiovascular comorbidities. By curing mild psoriasis with a short-term anti- interleukin (IL)-17A treatment, investigators may reduce the costs of treating psoriasis and associated medical conditions, including psoriatic arthritis, cardiovascular disease, and diabetes.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The imbalance between Type 17 T-cells and regulatory immune cell subsets in psoriasis vulgaris.
   Kim J, Moreno A, Krueger JG. · · 2022 · cited 32× · PMID 36110854 · DOI 10.3389/fimmu.2022.1005115
2. Multi-omics segregate different transcriptomic impacts of anti-IL-17A blockade on type 17 T-cells and regulatory immune cells in psoriasis skin.
   Kim J, Lee J, Li X, Kunjravia N, et al · · 2023 · cited 15× · PMID 37781383 · DOI 10.3389/fimmu.2023.1250504
3. Secukinumab improves mild-to-moderate psoriasis: A randomized, placebo-controlled exploratory clinical trial.
   Kim J, Lee J, Hawkes JE, Li X, et al · · 2023 · cited 9× · PMID 35551962 · DOI 10.1016/j.jaad.2022.04.060