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PruritusPhase 1/2NCT01605708

Study to Assess the Clinical Activity of a Sequential Dose of REGN846 on Refractory Pruritus in Patients With Atopic Dermatitis

A Phase 1/2 study testing REGN846 in people with Pruritus and Atopic Dermatitis, run by Regeneron Pharmaceuticals at 14 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe atopic dermatitis (AD). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pruritus, Atopic Dermatitis
What is being tested?
REGN846
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
14 sitesin 3 countries
Study dates
Jun 2012to Apr 2013
Phase
Phase 1/2
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inclusion criteria include, but are not limited to the following:
  • Men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
  • Patients must have applied a stable dose of an additive-free, basic, bland emollient twice daily for at least 7 days before the baseline visit
  • Chronic Atopic Dermatitis (AD)
  • Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
  • Refractory pruritus for ≥ 6 weeks before screening. Pruritus should be associated only with AD and not with any other condition(s).
  • Itching associated with AD

Who cannot join

  • Exclusion criteria include, but are not limited to the following:
  • A history of listeriosis.
  • Presence of any 1 of the following tuberculosis (TB) criteria:
  • A history of active TB
  • A positive QuantiFERON TB test at the screening visit
  • Chest radiograph (posterior-anterior and lateral views) at screening or within 3 months before the screening visit (radiology report must be available) with results consistent with prior TB infection (including but not limited to apical scarring, apical fibrosis, or multiple calcified granuloma). This does not include non-caseating granulomata.
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  • Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit.
  • Any clinically significant physical abnormalities observed during the screening visit.
  • Diabetic, hypertensive, or any known atherosclerotic vascular disease.
  • Hospitalization for any reason within 60 days of the screening visit.
  • History of or positive human immunodeficiency virus (HIV) screen result at the screening visit.
  • History of positive blood test for hepatitis B/hepatitis C or positive hepatitis screen result at the screening visit.
  • Known sensitivity to doxycycline or tetracycline.
  • Known sensitivity to any of the components or excipients of the investigational product formulation or history of hypersensitivity to any biologic agent.
  • Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit.
  • Any medical or psychiatric condition that in the opinion of the investigator or Regeneron, would place the patient at risk, interfere with participation in the study or interfere with the interpretation of study results.

Trial locations and contacts

14 sites in 3 countries.

14 sites in 3 countries

Germany8 sites

  • Study site

    Berlin

  • Study site

    Dresden

  • Study site

    Erfurt

  • Study site

    Frankfurt

  • Study site

    Mahlow

  • Study site

    Mainz

  • Study site

    Osnabrück

  • Study site

    Tübingen

Other trials in Germany

Poland4 sites

  • Study site

    Bydgoszcz

  • Study site

    Poznan

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Finland2 sites

  • Study site

    Helsinki

  • Study site

    Tampere

Other trials in Finland

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending Dose Study of the Clinical Activity, Safety, Tolerability and Pharmacokinetics of a Single IV Dose of REGN846 in Refractory Moderate-to-Severe Pruritus in Adult Patients With Moderate-to-Severe Atopic Dermatitis

The purpose of this study is to assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe atopic dermatitis (AD).

Being tested
REGN846
Keywords
Itching
Medical subject headings
Pruritus, Dermatitis, Atopic

What participants receive

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

  • REGN846Drug

    Dose 1

Study groups in NCT01605708
Study groupRoleWhat they receive
Cohort 1ExperimentalNot described
Receives: Drug: REGN846

What is being measured

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

  1. Clinical Activity

    To assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe AD.

    Measured: Week 2

  2. Clinical Activity

    To assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe AD.

    Measured: Week 4

  3. Clinical Activity

    To assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe AD.

    Measured: Week 6

Secondary outcomes (3)

  1. Safety and tolerability a single IV dose of REGN846

    To assess the safety and tolerability of REGN846 in adult patients who have moderate-to-severe AD with refractory moderate-to-severe pruritus.

    Measured: Week 1 - Week 6

  2. Pharmacokinetic (PK) profile of a single IV dose of REGN846

    To assess the PK profile of REGN846 in adult patients who have moderate-to-severe AD with refractory moderate-to-severe pruritus.

    Measured: Week 1 - Week 6

  3. Immunogenicity of a single IV dose of REGN846

    To assess the immunogenicity of REGN846 in adult patients who have moderate-to-severe AD with refractory moderate-to-severe pruritus.

    Measured: Week 1 - Week 6

Timeline

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

  1. First posted25 May 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionApr 2013
  4. Study completionApr 2013

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01605708
Sponsor's protocol ID
R846-AD-1105
Status last verified
May 2013
First submitted
12 Oct 2011
Last updated
28 Oct 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing REGN846 in people with Pruritus and Atopic Dermatitis, run by Regeneron Pharmaceuticals at 14 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 7 inclusion and 16 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: stopped early, as of the sponsor's last update on 28 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany, Poland, Finland. 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 combined 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.

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?

The study was stopped early. Results are not available in the source record.

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?

Clinical Activity (time frame: Week 2). 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 NCT01605708.

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 28 Oct 2013.

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