Moderate to Severe Chronic Plaque-type PsoriasisPhase 3NCT03668613

Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis

A Phase 3 study testing secukinumab low dose and secukinumab high dose in people with Moderate to Severe Chronic Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 23 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This was an open-label, parallel-group, two-arm, multicenter study in pediatric subjects aged 6 years to less than 18 years, at randomization, with moderate to severe chronic plaque psoriasis. 84 subjects (most with moderate severity) were enrolled. Subjects were stratified by weight and disease severity. Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Moderate to Severe Chronic Plaque-type Psoriasis
What is being tested?: secukinumab low dose and secukinumab high dose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 23 sitesin 9 countries
Study dates: 29 Aug 2018to 12 Sep 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Written informed assent and parental permission (age as per local law) obtained at screening before any assessment is performed.
Must be 6 to less than 18 years of age at the time of randomization
Moderate to Severe plaque psoriasis, defined as a PASI score ≥ 12, and IGA mod 2011 score of ≥ 3, and BSA involvement of ≥10%, at randomization.
Subject being regarded by the investigator to be a candidate for systemic therapy.

Who cannot join

Forms of psoriasis other than chronic plaque-type active at randomization
Drug-induced psoriasis
Ongoing use of prohibited treatments
Female subjects of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing and for 16 weeks after stopping study treatment
Pregnant or nursing (lactating) females
Subjects with total WBC count <2,500/μL, or platelets <100,000/μL or neutrophils <1,500/μL or hemoglobin <8.5 g/dL at screening
Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor

Trial locations and contacts

23 sites in 9 countries.

Country

City, postcode or hospital

23 sites in 9 countries

United States4 sites

First OC Dermatology
Fountain Valley, California, 92708
Private Practice
Jacksonville, Florida, 32256
Novartis Investigative Site
Lebanon, New Hampshire, 03756
Texas Derm and Laser Specialists .
San Antonio, Texas, 78218

Other trials in United States

Russia4 sites

Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Krasnodar, 350020
Novartis Investigative Site
Moscow, 119296
Novartis Investigative Site
Saint Petersburg, 191123

Other trials in Russia

Spain4 sites

Novartis Investigative Site
Esplugues de Llobregat, Barcelona, 08950
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Sabadell, Barcelona, 08208
Novartis Investigative Site
Valencia, 46026

Other trials in Spain

Poland3 sites

Novartis Investigative Site
Rzeszów, 35 055
Novartis Investigative Site
Warsaw, Mazowian, 02 495
Novartis Investigative Site
Wroclaw, 50-566

Other trials in Poland

Belgium2 sites

Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Liège, 4000

Other trials in Belgium

Czechia2 sites

Novartis Investigative Site
Hradec Králové, CZE, 500 05
Novartis Investigative Site
Prague, Prague 1, 11000

Other trials in Czechia

Germany2 sites

Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Münster, 48149

Other trials in Germany

Estonia1 site

Novartis Investigative Site
Tartu, 50406

Other trials in Estonia

Peru1 site

Novartis Investigative Site
Lima, 1

Other trials in Peru

About this study

Official title: A Randomized, Open-label, Multicenter Trial to Assess the Efficacy of Subcutaneous Secukinumab after12 Weeks of Treatment, and to Assess the Long-term Safety, Tolerability, Efficacy in Subjects From 6 to <18 Years of Age With Moderate to Severe Chronic Plaque Psoriasis

Read the detailed description

This was an open-label, parallel group, two-arm, multi-center, trial in pediatric subjects aged 6 years to less than 18 years, at randomization, with moderate to severe chronic, plaque psoriasis. The study consists of 3 periods: screening (up to 4 weeks), treatment (Week 208) and post-treatment follow-up (Week 224).

Approximately 80 subjects (at least 60 subjects with moderate psoriasis) were planned to be enrolled in about 40 centers worldwide and targeted to have at least 5 subjects in the < 25kg body weight, and at least 10 subjects in each of the other two weight groups (25-< 50 kg and ≥ 50 kg). Adolescents (12-< 18 years) and children (6-< 12 years) were included from the beginning of this study, since the DMC had approved already the enrollment of children (6-< 12 years) in the study CAIN457A2310 (NCT02471144). Subjects received the appropriate dose based on their body weight category.

For the statistical analysis for outcome measures 1 and 2, there was no 'within study' control arm. A historical placebo control was obtained using data from qualifying trials and used as the comparator for the primary and key secondary endpoint analysis. This was in line with the guidance from and discussions with Health Authorities including FDA and EMA (PDCO), which suggested reducing placebo exposure as well as overall clinical trial burden for the pediatric population and accepted an extrapolation approach (EMA 2012). Historical placebo data included in this study were based on clinical appropriateness and alignment of definitions (endpoints, clinical disease population and time point of assessment). Integrated in the analysis were placebo data from Novartis-reported secukinumab adult placebo-controlled studies (CAIN457A2302 (NCT01544595 and NCT01365455), CAIN457A2303 (NCT01544595 and NCT01358578), CAIN457A2308 (NCT01555125) and CAIN457A2309 (NCT01636687)) and pediatric placebo-controlled study CAIN457A2310. In addition, pediatric placebo-controlled study data from the literature on other biologics (e.g. etanercept, ustekinumab) were utilized (Paller et al 2008, Landells et al 2015).

If the subject moved into a higher or lower weight group at two consecutive visits with weight measurements during the maintenance (from Week 12 onwards as assessed at 4 weekly visits or during extension treatment period (as assessed at scheduled site visits), then the subject was dosed according to the new (higher or lower) weight group respectively.

Conditions: Moderate to Severe Chronic Plaque-type Psoriasis
Being tested: secukinumab low dose, secukinumab high dose
Keywords: pediatric, secukinumab, plaque psoriasis, AIN457A, Skin condition, skin disease, itching condition, psoriasis vulgaris, relapsing/remitting psoriasis, immune-mediated systemic disease, skin lesions, red skin lesions, scaly patches, papules, plaques, itching
Medical subject headings: Skin Diseases, Recurrence, Plaque, Amyloid, Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

secukinumab low doseDrug
Also called AIN457
dose depends on the weight group
secukinumab high doseDrug
Also called AIN457
dose depends on the weight group

Study groups in NCT03668613
Study group	Role	What they receive
secukinumab low dose	Experimental	secukinumab low dose Receives: Drug: secukinumab low dose
secukinumab high dose	Experimental	secukinumab high dose Receives: Drug: secukinumab high dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Number and Percentage of Participants With PASI 75 Response
Psoriasis Area and Severity Index (PASI):Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs and lower limbs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, Erythema,Thickening (plaque elevation, induration) \& Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 body: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 75 represents the percentage (or number)of patients who have achieved a 75% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.
Measured: Week 12
Number and Percentage of Participants With IGA Mod 2011 0 or 1 Response
Investigator will assess the disease using the validated Investigator Global Assessment (IGA) mod 2011 and rate the disease from a score of 0 (clear skin) to 4 (severe disease)
Measured: Week 12

Secondary outcomes (3)

Number and Percentage of Participants With PASI 90 Response
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per the standard procedure.
PASI 90 represents the percentage (or number) of patients who have achieved a 90% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.
Measured: Week 12
Secukinumab Concentration in Serum
Mean (Standard Deviation) Secukinumab concentration levels in serum over time.
Measured: Baleine, Weeks 4, 12, 13, 14, 15, 16, 24, 52, 104, 156, 208
Summary Table of Adverse Events
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Measured: Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Aug 201812 Sep 2023

First posted12 Sep 2018
Study start29 Aug 2018
Primary completion19 Sep 2019
Study completion12 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Moderate to Severe Chronic Plaque-type PsoriasisStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03668613
Sponsor's protocol ID: CAIN457A2311
Other IDs: 2017-004515-39, 2017
Status last verified: May 2025
First submitted: 23 Aug 2018
Last updated: 16 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Publications

Kingo K, Papanastasiou P, Beissert S, Lazareva S, Villa AV, Bartonova J, Ballona R, Bansal A, Martin R, Fan H, O'Doherty C, Ravichandran S, Magnolo N. Long-Term Efficacy and Safety of Secukinumab in Children and Adolescents with Moderate-to-Severe Chronic Plaque Psoriasis: Four-Year Results of a Randomized, Phase III, Open-Label Trial. Paediatr Drugs. 2025 Nov;27(6):749-759. doi: 10.1007/s40272-025-00715-4. Epub 2025 Aug 28.
PubMed 40874954
Sticherling M, Nikkels AF, Hamza AM, Kwong P, Szepietowski JC, El Sayed M, Ghislain PD, Khotko AA, Patekar M, Ortmann CE, Forrer P, Papanastasiou P, Keefe D. Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials. Am J Clin Dermatol. 2023 Sep;24(5):821-835. doi: 10.1007/s40257-023-00782-8. Epub 2023 Jun 21.
PubMed 37341961
Magnolo N, Kingo K, Laquer V, Browning J, Reich A, Szepietowski JC, Keefe D, Papanastasiou P, Bao W, Forrer P, Patekar M. Efficacy of Secukinumab Across Subgroups and Overall Safety in Pediatric Patients with Moderate to Severe Plaque Psoriasis: Week 52 Results from a Phase III Randomized Study. Paediatr Drugs. 2022 Jul;24(4):377-387. doi: 10.1007/s40272-022-00507-0. Epub 2022 Jun 13.
PubMed 35698000
Magnolo N, Kingo K, Laquer V, Browning J, Reich A, Szepietowski JC, Keefe D, Mazur R, Ghelani P, Forrer P, Wraith L, Patekar M. A phase 3 open-label, randomized multicenter study to evaluate efficacy and safety of secukinumab in pediatric patients with moderate to severe plaque psoriasis: 24-week results. J Am Acad Dermatol. 2022 Jan;86(1):122-130. doi: 10.1016/j.jaad.2021.08.066. Epub 2021 Sep 30.
PubMed 34555481

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Multicenter Trial to Assess the Efficacy of Subcutaneous Secukinumab after12 Weeks of Treatment, and to Assess the Long-term Safety, Tolerability, Efficacy in Subjects From 6 to <18 Years of Age With Moderate to Severe Chronic Plaque Psoriasis
ClinicalTrials.gov ID: NCT03668613
Acronym / sponsor ID: CAIN457A2311
Conditions: Moderate to Severe Chronic Plaque-type Psoriasis
Keywords: pediatric, secukinumab, plaque psoriasis, AIN457A, Skin condition, skin disease, itching condition, psoriasis vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 29 Aug 2018 (actual)
Primary completion: 19 Sep 2019 (actual)
Study completion: 12 Sep 2023 (actual)
First posted: 12 Sep 2018 (actual)
Results: Posted 23 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
secukinumab low dose	Experimental	Drug: secukinumab low dosesecukinumab low dose
secukinumab high dose	Experimental	Drug: secukinumab high dosesecukinumab high dose

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Written informed assent and parental permission (age as per local law) obtained at screening before any assessment is performed.
Must be 6 to less than 18 years of age at the time of randomization
Moderate to Severe plaque psoriasis, defined as a PASI score ≥ 12, and IGA mod 2011 score of ≥ 3, and BSA involvement of ≥10%, at randomization.
Subject being regarded by the investigator to be a candidate for systemic therapy.

Key exclusion criteria (7 listed)

Forms of psoriasis other than chronic plaque-type active at randomization
Drug-induced psoriasis
Ongoing use of prohibited treatments
Female subjects of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing and for 16 weeks after stopping study treatment
Pregnant or nursing (lactating) females

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
secukinumab low doseAlso: AIN457dose depends on the weight group	Drug	secukinumab low dose
secukinumab high doseAlso: AIN457dose depends on the weight group	Drug	secukinumab high dose

Primary outcome

Number and Percentage of Participants With PASI 75 Response
Time frame: Week 12
Psoriasis Area and Severity Index (PASI):Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs and lower limbs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, Erythema,Thickening (plaque elevation, induration) \& Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 body: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 75 represents the percentage (or number)of patients who have achieved a 75% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.
Number and Percentage of Participants With IGA Mod 2011 0 or 1 Response
Time frame: Week 12
Investigator will assess the disease using the validated Investigator Global Assessment (IGA) mod 2011 and rate the disease from a score of 0 (clear skin) to 4 (severe disease)

3 secondary outcomes

Number and Percentage of Participants With PASI 90 Response
Time frame: Week 12
Secukinumab Concentration in Serum
Time frame: Baleine, Weeks 4, 12, 13, 14, 15, 16, 24, 52, 104, 156, 208
Summary Table of Adverse Events
Time frame: Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks.

Results and safety

Results posted to the registry on 23 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AIN457 Low Dose	42	31
AIN457 High Dose	42	36

Primary outcome: Number and Percentage of Participants With PASI 75 Response

Time frame: Week 12. Count of participants. Unit: Participants

Measure	AIN457 Low Dose n = 42	AIN457 High Dose n = 42
Value	39	39

AIN457 Low Dose: Predicted Log-OR: 4.862 (95% CI 3.422 to 6.782), Bayesian method using (MAP)
AIN457 High Dose: Predicted log-OR: 4.836 (95% CI 3.422 to 6.772), Bayesian method using (MAP)

Population analysed: Full Analysis Set: The FAS comprised all patients from the randomized set to whom study treatment had been assigned

Primary outcome: Number and Percentage of Participants With IGA Mod 2011 0 or 1 Response

Time frame: Week 12. Count of participants. Unit: Participants

Measure	AIN457 Low Dose n = 42	AIN457 High Dose n = 42
Value	33	35

AIN457 Low Dose: Predicted log -OR: 4.292 (95% CI 2.638 to 6.513), Bayesian method using (MAP)
AIN457 High Dose: Predicted log-OR: 4.606 (95% CI 2.919 to 6.780), Bayesian method using (MAP)

Population analysed: Full Analysis Set: The FAS comprised all patients from the randomized set to whom study treatment had been assigned

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AIN457 Low Dose	4 of 42 (9.5%)	30 of 42 (71.4%)	0 of 42
AIN457 High Dose	2 of 42 (4.8%)	27 of 42 (64.3%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40874954Kingo K, Papanastasiou P, Beissert S, Lazareva S, Villa AV, Bartonova J, Ballona R, Bansal A, Martin R, Fan H, O'Doherty C, Ravichandran S, Magnolo N. Long-Term Efficacy and Safety of Secukinumab in Children and Adolescents with Moderate-to-Severe Chronic Plaque Psoriasis: Four-Year Results of a Randomized, Phase III, Open-Label Trial. Paediatr Drugs. 2025 Nov;27(6):749-759. doi: 10.1007/s40272-025-00715-4. Epub 2025 Aug 28.
Derived from this study: PubMed 37341961Sticherling M, Nikkels AF, Hamza AM, Kwong P, Szepietowski JC, El Sayed M, Ghislain PD, Khotko AA, Patekar M, Ortmann CE, Forrer P, Papanastasiou P, Keefe D. Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials. Am J Clin Dermatol. 2023 Sep;24(5):821-835. doi: 10.1007/s40257-023-00782-8. Epub 2023 Jun 21.
Derived from this study: PubMed 35698000Magnolo N, Kingo K, Laquer V, Browning J, Reich A, Szepietowski JC, Keefe D, Papanastasiou P, Bao W, Forrer P, Patekar M. Efficacy of Secukinumab Across Subgroups and Overall Safety in Pediatric Patients with Moderate to Severe Plaque Psoriasis: Week 52 Results from a Phase III Randomized Study. Paediatr Drugs. 2022 Jul;24(4):377-387. doi: 10.1007/s40272-022-00507-0. Epub 2022 Jun 13.
Derived from this study: PubMed 34555481Magnolo N, Kingo K, Laquer V, Browning J, Reich A, Szepietowski JC, Keefe D, Mazur R, Ghelani P, Forrer P, Wraith L, Patekar M. A phase 3 open-label, randomized multicenter study to evaluate efficacy and safety of secukinumab in pediatric patients with moderate to severe plaque psoriasis: 24-week results. J Am Acad Dermatol. 2022 Jan;86(1):122-130. doi: 10.1016/j.jaad.2021.08.066. Epub 2021 Sep 30.
A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

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.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

23 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing secukinumab low dose and secukinumab high dose in people with Moderate to Severe Chronic Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 23 sites in 9 countries.

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 4 inclusion and 7 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Russia, Spain, Poland, Belgium and 4 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number and Percentage of Participants With PASI 75 Response (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03668613, which also lists 4 linked publications.

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 16 May 2025.