PsoriasisPhase 4NCT04571567
A Study to Evaluate the Efficacy and Safety of Secukinumab in Adult Patients With Skin Types IV-VI With Moderate to Severe Plaque Psoriasis
A Phase 4 study testing Secukinumab in people with Psoriasis, run by Saakshi Khattri at 1 site in United States.
Trial summary
This will be a single-center, open-label clinical study to determine the efficacy and safety of secukinumab in the treatment of moderate to severe psoriasis vulgaris in skin of color (SOC) (FST IV-VI). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Secukinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2019to 22 Feb 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide written, signed and dated informed consent prior to initiating any study-related activities.
- Male or female ≥18 years of age at the time of screening
- Fitzpatrick Skin phototype IV-VI, non-white race/ethnicity, including but not limited to African Americans, Asians, Pacific Islanders and Hispanics
- Clinical diagnosis of chronic plaque-type psoriasis of the body for at least 6 months prior to randomization
- Moderate to severe plaque psoriasis at randomization as defined by: PASI≥12 AND BSA ≥ 10% AND IGA mod 2011 ≥ 3 (scale 0-4)
- Candidate for systemic therapy, as defined by having psoriasis inadequately controlled by topical treatments and/or phototherapy and/or previous systemic therapy
- Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While using investigational product and for at least 28 days after last application of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
- Must be in general good health as judged by the Investigator, based on medical history and physical examination. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
Who cannot join
- Form of diagnosed psoriasis other than chronic plaque psoriasis (i.e. guttate, erythrodermic, pustular) or drug-induced psoriasis
- Subjects with lighter skin as defined by Fitzpatrick Skin Types I-III
- Subjects of European ancestry or other white ethnic group
- Previous exposure to secukinumab or other biologic agent targeting IL-17A or IL-17RA
- Ongoing use of prohibited treatments or lack of adherence to specified washout periods:
- 6 months for biologic drugs directly targeting IL-12/23 or IL-23, alefacept, and efalizumab
Show all 20Show fewer
- 12 weeks for biologic agents other than the above (i.e. adalimumab, etanercept, infliximab)
- 4 weeks for other systemic psoriasis treatments (i.e. methotrexate, systemic steroids, retinoids, apremilast), and photochemotherapy
- 2 weeks for phototherapy (UVA, UVB)
- 2 weeks for topical psoriasis therapies
- Subjects unwilling to limit exposure to UV light
- Use of other investigational drugs within 5 half-lives prior to randomization
- Pregnant/nursing women or women of child-bearing potential unwilling to use appropriate method of contraception
- Diagnosis of other ongoing skin disease or skin infection that may interfere with the treatment and/or examination of psoriasis lesions
- Current significant medical problems or laboratory abnormalities that, in the opinion of the investigator, would put the patient at significant risk by participating in the study
- Previous history of or current infection with hepatitis C, hepatitis B, or HIV
- Active systemic infection during the 2 weeks prior to randomization
- Evidence of tuberculosis infection (indeterminate or positive quantiferon gold) at screening. Subject may be enrolled if full tuberculosis workup has been completed in the 12 weeks preceding randomization and patient has been started on appropriate treatment at least 4 weeks prior to randomization
- Malignancy with the past 5 years, with the exception of basal cell carcinoma, actinic keratosis, Bowen's disease of the skin, carcinoma in situ of the cervix(removed) or non-invasive malignant color polyps (removed)
- History of allergy to any component of the IP
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai West Dermatolgy
New York, New York, 10023
About this study
Official title: A Single-center, Open Label Study to Evaluate the Efficacy and Safety of Secukinumab in Adult Patients With Skin Types IV-VI With Moderate to Severe Plaque Psoriasis
This will be a single-center, open-label clinical study to determine the efficacy and safety of secukinumab in the treatment of moderate to severe psoriasis vulgaris in skin of color (SOC) (FST IV-VI). This study will also evaluate the degree of erythema versus hyperpigmentation in psoriasis plaques in SOC (and its change with secukinumab treatment) as well as the effect of secukinumab on post-inflammatory hyperpigmentation and quality of life in SOC.
Read the detailed description
Psoriasis is a chronic inflammatory disorder primarily affecting the skin and joints that occurs in diverse ethnic groups worldwide. There is paucity of data on the use of topical and systemic medications in dark-skinned individuals. Unique issues in skin of color (SOC) populations, including increased risk of dyspigmentation (hyperpigmentation and hypopigmentation), make studies dedicated to darker skin types essential for treatment of psoriasis in these populations.
This will be a single-center, open-label clinical study to evaluate the efficacy and safety of secukinumab in adults with skin types IV-VI with moderate to severe plaque psoriasis. A total of 20 subjects (ages 18+, male and female, BSA ≥10%, PASI Score ≥ 12, IGA mod 2011 score ≥ 3) are expected to complete this study, which will run for a total of up to 28 weeks.
The study consists of two periods: Screening (from 0 to 4 weeks) and open-label treatment period (24 weeks). During the second period, a total of 20 subjects will receive secukinumab 300mg subcutaneously. Those who meet all of the inclusion/exclusion criteria and are enrolled in the study will receive study drug for the entire treatment period.
- Conditions
- Psoriasis
- Being tested
- Secukinumab
- Keywords
- Psoriasis, Skin of Color, Moderate, Severe
- Medical subject headings
- Psoriasis, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
Each 300mg dose is given as two subcutaneous injections of secukinumab 150mg, 1mg liquid formulation in a pre-filled syringe.
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Experimental | 300mg subcutaneously Receives: Drug: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psoriasis Area Severity Index (PASI) 90
Proportion of patients achieving ≥90% improvement in Psoriasis Area Severity Index (PASI) at week 16 compared to baseline (PASI90). PASI will be assessed at baseline and then at regular intervals until week 24.
Measured: Baseline, Week 16 and Week 24
Secondary outcomes (10)
Change in PASI 75
PASI 75 at weeks 4, 12, 16, 24 - Proportion of patients achieving ≥75% improvement in Psoriasis Area Severity Index (PASI) at weeks 4, 12, 16, and 24 compared to baseline (PASI75).
Measured: Baseline, Weeks 4, 12, 16, and 24
Change in PASI 90
PASI 90 at weeks 4, 12, 24 - Proportion of patients achieving ≥90% improvement in Psoriasis Area Severity Index (PASI) at weeks 4, 12, and 24 compared to baseline (PASI90).
Measured: Baseline, Weeks 4, 12, 16, and 24
Change in PASI 100
PASI 100 at weeks 4, 12, 16, 24 - Proportion of patients achieving 100% improvement in Psoriasis Area Severity Index (PASI) at weeks 4, 12, 16, and 24 compared to baseline (PASI100).
Measured: Baseline, Weeks 4, 12, 16, and 24
Change in Investigator Global Assessment (IGA) mod 2011
IGA mod 2011 0/1 at weeks 12, 16, 24 - Proportion of patients at weeks 12, 16, and 24 who achieved treatment success according to investigator global assessment (IGA mod 2011) of the entire body including scalp. IGA full range from 0 (clear) to 4 (severe). Treatment success is defined as IGA of clear (0) or almost clear (1).
Measured: Weeks 12, 16, and 24
Change in The Physician Global Assessment and Body Surface Area (PGAxBSA) score
≥75% reduction in IGAxBSA score (IGAxBSA-75) at week 16 - ≥75% improvement in PGAxBSA Composite Tool between week 16 and baseline. The PGAxBSA score is calculated by multiplying the static PGA score by the BSA (range: 0 to 400 [eg, maximum static PGA = 4 and maximum BSA = 100]).
Measured: Baseline and Week 16
Change in melanin index (MI)
Change in melanin index (MI) of target lesion at weeks 12, 16, 24 compared to week 4. Melanin index total scale from 0-999, higher score indicates higher melanin content.
Measured: Weeks 4, 12, 16, 24
Change in erythema index (EI)
A skin spectrophotometer (Mexameter) will be used to quantify the MI (degree of hyperpigmentation or hypopigmentation) and EI of lesional skin compared to an index area of unaffected skin at baseline, week 4, week 12, week 16, and week 24 as compared to baseline. Full scale from 0-4, higher score indicates more erythema
Measured: Baseline, Weeks 4, 12, 16, and 24
Change in physician numeric rating scale (physician)
The physician dyspigmentation NRS ranges from 5 (severe dark brown pigmentation) to -5 (complete absence of pigment), with 0 being baseline skin pigmentation. The scale is as follows: 5 severe dark brown pigmentation (darkest imaginable color), 4 dark brown pigmentation, 3 medium brown pigmentation, 2 light brown pigmentation, 1 slight dark pigmentation (barely perceptible compared to surrounding skin), 0 baseline skin pigmentation, -1 slight hypopigmentation (barely perceptible compared to surrounding skin), -2 mild hypopigmentation (light brown), -3 moderate hypopigmentation (creme-colored skin), -4 severe hypopigmentation (almost complete absence of pigment), -5 depigmentation (complete absence of pigment). Only one number along the scale will be chosen (corresponding to either hypopigmentation or hyperpigmentation). Change at weeks 12, 16, and 24 compared to Week 4.
Measured: Baseline, Weeks 4, 12, 16, and 24
Change in patient-rated visual analog scale
The NRS ranges from 5 (severe dark brown pigmentation) to -5 (complete absence of pigment), with 0 being baseline skin pigmentation. The scale is as follows: 5 severe dark brown pigmentation (darkest imaginable color), 4 dark brown pigmentation, 3 medium brown pigmentation, 2 light brown pigmentation, 1 slight dark pigmentation (barely perceptible compared to surrounding skin), 0 baseline skin pigmentation, -1 slight hypopigmentation (barely perceptible compared to surrounding skin), -2 mild hypopigmentation (light brown), -3 moderate hypopigmentation (creme-colored skin), -4 severe hypopigmentation (almost complete absence of pigment), -5 depigmentation (complete absence of pigment). Only one number along the scale will be chosen (corresponding to either hypopigmentation or hyperpigmentation). Change at weeks 12, 16, and 24 compared to Week 4.
Measured: Baseline, Weeks 4, 12, 16, and 24
Change in the Dermatology Life Quality Index (DLQI)
Change from baseline in DLQI total score and proportion of subjects achieving DLQI 0/1 at weeks 12, 16, 24. Full scale from 0-10, with higher score indicating more impact on quality of life
Measured: Weeks 12, 16, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start2 Dec 2019
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Secukinumab is a recombinant, high-affinity, fully human immunoglobulin G1κ monoclonal antibody targeting IL-17A. Phase III studies have demonstrated the safety and efficacy of secukinumab in the treatment of moderate-to-severe psoriasis when dosed as 300mg by subcutaneous injection at weeks 0, 1, 2, 3, and 4 followed by 300mg every 4 weeks.12 Secukinumab is FDA approved for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older. The study treatment consists of secukinumab 300mg by subcutaneous injection. Each 300mg dose is given as two subcutaneous injections of secukinumab 150mg, 1mg liquid formulation in a pre-filled syringe. Secukinumab pre-filled syringes 150 mg will be supplied by Novartis.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saakshi Khattri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Saakshi Khattri, Icahn School of Medicine at Mount Sinai
- Investigators
- Saakshi Khattri, M.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571567
- Sponsor's protocol ID
- GCO 18-2408
- Other IDs
- CAIN457AUS16T
- Status last verified
- Apr 2022
- First submitted
- 26 Sep 2020
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open Label Study to Evaluate the Efficacy and Safety of Secukinumab in Adult Patients With Skin Types IV-VI With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04571567
- Acronym / sponsor ID
- GCO 18-2408
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Skin of Color, Moderate, Severe
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Saakshi KhattriUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single-center, open-label clinical study to determine the efficacy and safety of secukinumab in the treatment of moderate to severe psoriasis vulgaris in skin of color (SOC) (FST IV-VI). This study will also evaluate the degree of erythema versus hyperpigmentation in psoriasis plaques in SOC (and its change with secukinumab treatment) as well as the effect of secukinumab on post-inflammatory hyperpigmentation and quality of life in SOC.
Detailed description
Psoriasis is a chronic inflammatory disorder primarily affecting the skin and joints that occurs in diverse ethnic groups worldwide. There is paucity of data on the use of topical and systemic medications in dark-skinned individuals. Unique issues in skin of color (SOC) populations, including increased risk of dyspigmentation (hyperpigmentation and hypopigmentation), make studies dedicated to darker skin types essential for treatment of psoriasis in these populations.
This will be a single-center, open-label clinical study to evaluate the efficacy and safety of secukinumab in adults with skin types IV-VI with moderate to severe plaque psoriasis. A total of 20 subjects (ages 18+, male and female, BSA ≥10%, PASI Score ≥ 12, IGA mod 2011 score ≥ 3) are expected to complete this study, which will run for a total of up to 28 weeks.
The study consists of two periods: Screening (from 0 to 4 weeks) and open-label treatment period (24 weeks). During the second period, a total of 20 subjects will receive secukinumab 300mg subcutaneously. Those who meet all of the inclusion/exclusion criteria and are enrolled in the study will receive study drug for the entire treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Secukinumab is a recombinant, high-affinity, fully human immunoglobulin G1κ monoclonal antibody targeting IL-17A. Phase III studies have demonstrated the safety and efficacy of secukinumab in the treatment of moderate-to-severe psoriasis when dosed as 300mg by subcutaneous injection at weeks 0, 1, 2, 3, and 4 followed by 300mg every 4 weeks.12 Secukinumab is FDA approved for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older. The study treatment consists of secukinumab 300mg by subcutaneous injection. Each 300mg dose is given as two subcutaneous injections of secukinumab 150mg, 1mg liquid formulation in a pre-filled syringe. Secukinumab pre-filled syringes 150 mg will be supplied by Novartis.
| Arm | Type | Receives |
|---|---|---|
| Secukinumab | Experimental | Drug: Secukinumab300mg subcutaneously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide written, signed and dated informed consent prior to initiating any study-related activities.
- Male or female ≥18 years of age at the time of screening
- Fitzpatrick Skin phototype IV-VI, non-white race/ethnicity, including but not limited to African Americans, Asians, Pacific Islanders and Hispanics
- Clinical diagnosis of chronic plaque-type psoriasis of the body for at least 6 months prior to randomization
- Moderate to severe plaque psoriasis at randomization as defined by: PASI≥12 AND BSA ≥ 10% AND IGA mod 2011 ≥ 3 (scale 0-4)
Key exclusion criteria (20 listed)
- Form of diagnosed psoriasis other than chronic plaque psoriasis (i.e. guttate, erythrodermic, pustular) or drug-induced psoriasis
- Subjects with lighter skin as defined by Fitzpatrick Skin Types I-III
- Subjects of European ancestry or other white ethnic group
- Previous exposure to secukinumab or other biologic agent targeting IL-17A or IL-17RA
- Ongoing use of prohibited treatments or lack of adherence to specified washout periods:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SecukinumabEach 300mg dose is given as two subcutaneous injections of secukinumab 150mg, 1mg liquid formulation in a pre-filled syringe. | Drug | Secukinumab |
Primary outcome
Change in Psoriasis Area Severity Index (PASI) 90
Time frame: Baseline, Week 16 and Week 24
Proportion of patients achieving ≥90% improvement in Psoriasis Area Severity Index (PASI) at week 16 compared to baseline (PASI90). PASI will be assessed at baseline and then at regular intervals until week 24.
10 secondary outcomes
Change in PASI 75
Time frame: Baseline, Weeks 4, 12, 16, and 24
Change in PASI 90
Time frame: Baseline, Weeks 4, 12, 16, and 24
Change in PASI 100
Time frame: Baseline, Weeks 4, 12, 16, and 24
Change in Investigator Global Assessment (IGA) mod 2011
Time frame: Weeks 12, 16, and 24
Change in The Physician Global Assessment and Body Surface Area (PGAxBSA) score
Time frame: Baseline and Week 16
Change in melanin index (MI)
Time frame: Weeks 4, 12, 16, 24
Change in erythema index (EI)
Time frame: Baseline, Weeks 4, 12, 16, and 24
Change in physician numeric rating scale (physician)
Time frame: Baseline, Weeks 4, 12, 16, and 24
Change in patient-rated visual analog scale
Time frame: Baseline, Weeks 4, 12, 16, and 24
Change in the Dermatology Life Quality Index (DLQI)
Time frame: Weeks 12, 16, and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saakshi Khattri, M.D. principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Secukinumab in people with Psoriasis, run by Saakshi Khattri at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psoriasis Area Severity Index (PASI) 90 (time frame: Baseline, Week 16 and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.