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Atopic DermatitisPhase 2NCT02407756

A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)

A Phase 2 study testing Dupilumab in people with Atopic Dermatitis, run by Regeneron Pharmaceuticals at 26 sites in 6 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

The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for adolescents ≥12 to <18 years of age) or severe AD (for children ≥6 to <12 years of age). Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Dupilumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
26 sitesin 6 countries
Study dates
31 Mar 2015to 31 Mar 2016
Phase
Phase 2
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

  • Male or female patients ≥6 to <18 years of age with a diagnosis of 1. Atopic Dermatitis whose disease cannot be adequately controlled with topical medications
  • Minimum disease severity, as defined by Investigator's Global Assessment (IGA)
  • IGA = 3 or 4 in adolescents ≥12 to <18 year of age
  • IGA = 4 in children ≥6 to <12 years of age

Who cannot join

  • Recent treatment (within specific time windows before the baseline visit) with systemic immunosuppressive agents for eg. Systemic corticosteroids, live (attenuated) vaccines and other investigational drugs including biologics
  • History of any of the following infections:
  • Any systemic infection requiring treatment within 4 weeks before the baseline visit
  • Superficial skin infections within 1 week before the baseline visit
  • Known history of HIV infection
  • History of seropositivity to hepatitis B or C screening tests
Show all 13Show fewer
  • History of clinical endoparasitosis (ie, helminthic infection) within 12 months before the baseline visit, or high risk of helminthic infection, unless subsequent medical assessments (e.g. stool exam, blood tests, etc.) have ruled out the possibility of parasite infection/infestation
  • History of malignancy within 5 years before the baseline visit
  • Persistent (confirmed by repeated tests ≥2 weeks apart) elevated transaminases (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]) more than 3 times the upper limit of normal (ULN) during the screening period
  • Presence of any severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study
  • Presence of skin comorbidities that may interfere with study assessments
  • Females patients who are pregnant or breastfeeding
  • Female patients who are of reproductive potential and are sexually active, who are unwilling to use adequate methods of contraception

Trial locations and contacts

26 sites in 6 countries.

26 sites in 6 countries

Germany9 sites

  • Study site

    Dresden

  • Study site

    Frankfurt

  • Study site

    Gera

  • Study site

    Hamburg

  • Study site

    Kiel

  • Study site

    Lübeck

  • Study site

    Munich

  • Study site

    Münster

  • Study site

    Tübingen

Other trials in Germany

Poland5 sites

  • Study site

    Katowice

  • Study site

    Krakow

  • Study site

    Lodz

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Canada4 sites

  • Study site

    Markham, Ontario

  • Study site

    Peterborough, Ontario

  • Study site

    Waterloo, Ontario

  • Study site

    Windsor, Ontario

Other trials in Canada

Hungary4 sites

  • Study site

    Kaposvár

  • Study site

    Miskolc

  • Study site

    Szeged

  • Study site

    Szolnok

Other trials in Hungary

Czechia2 sites

  • Study site

    Kutná Hora

  • Study site

    Prague

Other trials in Czechia

United Kingdom2 sites

  • Study site

    Manchester

  • Study site

    Sheffield

Other trials in United Kingdom

About this study

Official title: A Phase 2a Study Investigating the Safety, Pharmacokinetics, Immunogenicity, and Exploratory Efficacy of Dupilumab in Patients Aged ≥6 to <18 Years With Atopic Dermatitis

The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for adolescents ≥12 to <18 years of age) or severe AD (for children ≥6 to <12 years of age).

The secondary objective of the study is to explore the immunogenicity and efficacy of dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to <18 years of age) or severe AD (for children ≥6 to <12 years of age).

Being tested
Dupilumab
Keywords
Eczema
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

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

Study groups in NCT02407756
Study groupRoleWhat they receive
Cohort 1ExperimentalCohort 1 will receive dupilumab dosing regimen 1
Receives: Drug: Dupilumab
Cohort 2ExperimentalCohort 2 will receive dupilumab dosing regimen 2
Receives: Drug: Dupilumab

What is being measured

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

  1. Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration

    Peak dupilumab concentration in serum following single dose administration. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.

    Measured: Day 2, 4, 8, 15, 22, 29, 36, 43, and 50

  2. PK of Dupilumab: Area Under the Plasma Concentration Versus Time Curve (AUClast) After Single Administration

    Mean AUC estimates were calculated using mean concentration data at each time point, using a non-compartmental approach (NCA). Calculated AUClast (computed from time zero to the time of the last positive concentration) are presented. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.

    Measured: Day 2, 4, 8, 15, 22, 29, 36, 43, and 50

  3. PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose

    Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of study drug.

    Measured: Pre-dose on Day 71 and Day 85

Secondary outcomes (5)

  1. Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD. Analysis was performed on safety analysis set (SAF) that included all subjects who received any study drug. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by last observation carried forward (LOCF).

    Measured: Baseline to Week 12 (one week after last dose)

  2. Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12

    SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis ("Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis". Dermatology (Basel) 186 (1): 23-31. 1993). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 [absent disease] to 103 [severe disease]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF.

    Measured: Baseline to Week 12 (one week after last dose)

  3. Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12

    Pruritus NRS scale is an assessment tool that is used to report the intensity of subject's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Subjects were asked the following question: how would a subject rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF.

    Measured: Baseline to Week 12 (one week after last dose)

  4. Percentage of Subjects With Investigator Global Assessment (IGA) Score of "0" or "1" (Clear or Almost Clear) at Week 12

    IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Analysis was performed on SAF. Subjects with rescue treatment usage during the Part B period were specified as non-responders from the time the rescue was used.

    Measured: Week 12

  5. Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12

    Body surface area affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined. Analysis was performed on SAF.

    Measured: Baseline to Week 12

Timeline

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

  1. First posted3 Apr 2015 (estimated)
  2. Study start31 Mar 2015
  3. Primary completion31 Mar 2016
  4. Study completion31 Mar 2016

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02407756
Sponsor's protocol ID
R668-AD-1412
Status last verified
Nov 2020
First submitted
31 Mar 2015
Last updated
27 Nov 2020
Data monitoring committee
Yes

Publications

  • Blauvelt A, Guttman-Yassky E, Paller AS, Simpson EL, Cork MJ, Weisman J, Browning J, Soong W, Sun X, Chen Z, Kosloski MP, Kamal MA, Delevry D, Chuang CC, O'Malley JT, Bansal A. Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022 May;23(3):365-383. doi: 10.1007/s40257-022-00683-2. Epub 2022 May 14.

    PubMed 35567671

  • Cork MJ, Thaci D, Eichenfield LF, Arkwright PD, Hultsch T, Davis JD, Zhang Y, Zhu X, Chen Z, Li M, Ardeleanu M, Teper A, Akinlade B, Gadkari A, Eckert L, Kamal MA, Ruddy M, Graham NMH, Pirozzi G, Stahl N, DiCioccio AT, Bansal A. Dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: results from a phase IIa open-label trial and subsequent phase III open-label extension. Br J Dermatol. 2020 Jan;182(1):85-96. doi: 10.1111/bjd.18476. Epub 2019 Oct 8.

    PubMed 31595499

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dupilumab in people with Atopic Dermatitis, run by Regeneron Pharmaceuticals at 26 sites in 6 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 13 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 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Germany, Poland, Canada, Hungary, Czechia and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 5 Oct 2020). 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?

Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration (time frame: Day 2, 4, 8, 15, 22, 29, 36, 43, and 50). The study lists 3 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 NCT02407756, which also lists 2 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 27 Nov 2020.

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