Atopic DermatitisPhase 1NCT01385657
Safety and Tolerability of Dupilumab in Participants With Moderate to Severe Atopic Dermatitis
A Phase 1 study testing Dupilumab and Background treatment in people with Atopic Dermatitis, run by Regeneron Pharmaceuticals at 13 sites in 3 countries.
Trial summary
The purpose of this study is to assess the safety and tolerability of repeated subcutaneous (SC) doses of Dupilumab in participants with moderate-to-severe atopic dermatitis (AD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Dupilumab and Background treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 31 Jul 2011to 31 Mar 2012
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years or older;
- Chronic AD diagnosed by the Eichenfield revised criteria of Hannifin and Rajka that had been present for at least 3 years before the screening visit;
- Eczema Area and Severity Index (EASI) score ≥ 12 at the screening and baseline visits;
- Investigator's Global Assessment (IGA) score ≥ 3 at the screening and baseline visits;
- ≥ 10% body surface area (BSA) of AD involvement at the screening and baseline visits;
- History of inadequate response to a stable (≥ 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.
Who cannot join
- Positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit;
- Treatment with an investigational drug within 8 weeks or within 5 half-lives, if known, whichever is longer, before the baseline visit;
- Treatment with leukotriene inhibitors within 4 weeks before the baseline visit;
- Treatment with systemic corticosteroids within 4 weeks before the baseline visit;
- Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit;
- Systemic treatment for AD with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit;
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- Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, or antifungals within 4 weeks before the screening visit or superficial skin infections within 1 week before the screening visit;
- Known history of human immunodeficiency virus (HIV) infection;
- History of clinical parasite infection, other than treated trichomoniasis;
- History of malignancy within 5 years before the baseline visit, with the following exceptions: participants with a history of completely treated carcinoma in-situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin were allowed;
- Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the participant at risk, interfere with participation in the study, or interfere with the interpretation of study results;
- Pregnant or breast-feeding women;
- Unwilling to use adequate birth control, if of reproductive potential and sexually active.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Germany6 sites
Study site
Berlin, 10117
Study site
Berlin, 10827
Study site
Bonn, North Rhine-Westphalia
Study site
Gera
Study site
Hanover, Lower Saxony
Study site
Münster
Australia4 sites
Study site
Carlton, Victoria
Study site
Kogarah, New South Wales
Study site
Nedlands, Western Australia
Study site
Woolloongabba, Queensland
New Zealand3 sites
Study site
Auckland
Study site
Caversham, Dunedin
Study site
Sydenham, Christchurch
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending, Repeated-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous REGN668 in Patients With Moderate-to-Severe Atopic Dermatitis
The purpose of this study is to assess the safety and tolerability of repeated subcutaneous (SC) doses of Dupilumab in participants with moderate-to-severe atopic dermatitis (AD).
- Conditions
- Atopic Dermatitis
- Being tested
- Placebo, Dupilumab, Background treatment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
A total of 4 doses were administered.
DupilumabDrug
Also called REGN668, SAR231893, Dupixent
A total of 4 doses were administered.
Background treatmentOther
Participants were required to apply stable doses of an additive-free, basic bland emollient on the affected areas of the skin twice daily throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Placebo (for Dupilumab) as a single subcutaneous (SC) injection on Day 1, 8, 15, and 22 Receives: Drug: Placebo; Other: Background treatment |
| Dupilumab 150 mg | Experimental | Dupilumab 150 mg as a single SC injection on Day 1, 8, 15, and 22 Receives: Drug: Dupilumab; Other: Background treatment |
| Dupilumab 300 mg | Experimental | Dupilumab 300 mg as a single SC injection on Day 1, 8, 15, and 22 Receives: Drug: Dupilumab; Other: Background treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study visit [Day 85]). Any TEAE included participants with both serious and non-serious AEs.
Measured: Baseline up to end of study (up to Day 85)
Secondary outcomes (3)
Pharmacokinetics of Dupilumab: Peak Plasma Concentration (Cmax)
Maximum Plasma Concentration of functional Dupilumab observed following the fourth (last) dose.
Measured: Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85
Pharmacokinetics of Dupilumab: Last Positive (Quantifiable) Concentration (Clast)
Last Positive (Quantifiable) Concentration of Dupilumab.
Measured: Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85
Pharmacokinetics of Dupilumab: Time of the Last Positive (Quantifiable) Concentration (Tlast)
Mean time of last measurable concentration of Dupilumab in actual days.
Measured: Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study start31 Jul 2011
- Primary completion31 Mar 2012
- Study completion31 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Regeneron 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385657
- Sponsor's protocol ID
- R668-AD-1026
- Status last verified
- Feb 2020
- First submitted
- 9 Jun 2011
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hamilton JD, Suarez-Farinas M, Dhingra N, Cardinale I, Li X, Kostic A, Ming JE, Radin AR, Krueger JG, Graham N, Yancopoulos GD, Pirozzi G, Guttman-Yassky E. Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2014 Dec;134(6):1293-1300. doi: 10.1016/j.jaci.2014.10.013.
PubMed 25482871Beck LA, Thaci D, Hamilton JD, Graham NM, Bieber T, Rocklin R, Ming JE, Ren H, Kao R, Simpson E, Ardeleanu M, Weinstein SP, Pirozzi G, Guttman-Yassky E, Suarez-Farinas M, Hager MD, Stahl N, Yancopoulos GD, Radin AR. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014 Jul 10;371(2):130-9. doi: 10.1056/NEJMoa1314768.
PubMed 25006719
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending, Repeated-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous REGN668 in Patients With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01385657
- Acronym / sponsor ID
- R668-AD-1026
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 31 Jul 2011 (actual)
- Primary completion
- 31 Mar 2012 (actual)
- Study completion
- 31 Mar 2012 (actual)
- First posted
- 30 Jun 2011 (estimated)
- 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.
The purpose of this study is to assess the safety and tolerability of repeated subcutaneous (SC) doses of Dupilumab in participants with moderate-to-severe atopic dermatitis (AD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: Placebo, Other: Background treatmentPlacebo (for Dupilumab) as a single subcutaneous (SC) injection on Day 1, 8, 15, and 22 |
| Dupilumab 150 mg | Experimental | Drug: Dupilumab, Other: Background treatmentDupilumab 150 mg as a single SC injection on Day 1, 8, 15, and 22 |
| Dupilumab 300 mg | Experimental | Drug: Dupilumab, Other: Background treatmentDupilumab 300 mg as a single SC injection on Day 1, 8, 15, and 22 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, 18 years or older;
- Chronic AD diagnosed by the Eichenfield revised criteria of Hannifin and Rajka that had been present for at least 3 years before the screening visit;
- Eczema Area and Severity Index (EASI) score ≥ 12 at the screening and baseline visits;
- Investigator's Global Assessment (IGA) score ≥ 3 at the screening and baseline visits;
- ≥ 10% body surface area (BSA) of AD involvement at the screening and baseline visits;
Key exclusion criteria (13 listed)
- Positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit;
- Treatment with an investigational drug within 8 weeks or within 5 half-lives, if known, whichever is longer, before the baseline visit;
- Treatment with leukotriene inhibitors within 4 weeks before the baseline visit;
- Treatment with systemic corticosteroids within 4 weeks before the baseline visit;
- Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit;
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 |
|---|---|---|
| PlaceboA total of 4 doses were administered. | Drug | Placebo |
| DupilumabAlso: REGN668, SAR231893, DupixentA total of 4 doses were administered. | Drug | Dupilumab 150 mg, Dupilumab 300 mg |
| Background treatmentParticipants were required to apply stable doses of an additive-free, basic bland emollient on the affected areas of the skin twice daily throughout the study. | Other | Dupilumab 150 mg, Dupilumab 300 mg, Placebo |
Primary outcome
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to end of study (up to Day 85)
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study visit [Day 85]). Any TEAE included participants with both serious and non-serious AEs.
3 secondary outcomes
Pharmacokinetics of Dupilumab: Peak Plasma Concentration (Cmax)
Time frame: Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85
Pharmacokinetics of Dupilumab: Last Positive (Quantifiable) Concentration (Clast)
Time frame: Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85
Pharmacokinetics of Dupilumab: Time of the Last Positive (Quantifiable) Concentration (Tlast)
Time frame: Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85
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 26 Feb 2020.
- Results publication: PubMed 25482871Hamilton JD, Suarez-Farinas M, Dhingra N, Cardinale I, Li X, Kostic A, Ming JE, Radin AR, Krueger JG, Graham N, Yancopoulos GD, Pirozzi G, Guttman-Yassky E. Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2014 Dec;134(6):1293-1300. doi: 10.1016/j.jaci.2014.10.013.
- Results publication: PubMed 25006719Beck LA, Thaci D, Hamilton JD, Graham NM, Bieber T, Rocklin R, Ming JE, Ren H, Kao R, Simpson E, Ardeleanu M, Weinstein SP, Pirozzi G, Guttman-Yassky E, Suarez-Farinas M, Hager MD, Stahl N, Yancopoulos GD, Radin AR. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014 Jul 10;371(2):130-9. doi: 10.1056/NEJMoa1314768.
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dupilumab and Background treatment in people with Atopic Dermatitis, run by Regeneron Pharmaceuticals at 13 sites in 3 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 6 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 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Australia, New Zealand. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline up to end of study (up to Day 85)). 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 NCT01385657, 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 26 Feb 2020.