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Atopic DermatitisPhase 2NCT00703573

A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 2 Doses of S-777469 in Patients With Atopic Dermatitis

A Phase 2 study testing S-777469 400 mg and S-777469 800 mg in people with Atopic Dermatitis, run by Shionogi at 33 sites in United States.

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 purpose of this study is to evaluate the safety and efficacy of 2 doses of S-777469 in patients with atopic dermatitis. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
S-777469 400 mg and S-777469 800 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
209 participants
Where
33 sitesUnited States
Study dates
May 2008to Dec 2009
Phase
Phase 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

None listed.

Who cannot join

  • Patients satisfying any of the following exclusion criteria are not eligible for enrollment into the double-blind treatment period:
  • Patient is under the age of legal consent, is mentally or legally incapacitated and/or has significant emotional problems at the time of study entry
  • Patient has an active dermatologic condition other than AD which may confound the diagnosis or evaluation of AD, such as scabies, allergic contact dermatitis, seborrheic dermatitis, cutaneous lymphoma, or psoriasis
  • Patient has a history of malignancy not in remission for >5 years, with the exception of cutaneous basal cell carcinoma and cutaneous squamous cell carcinoma
  • Presence of comorbid conditions that would preclude participation in the study, including:
  • Immune compromised state, including recent chemotherapy, immunotherapy, or organ transplant
Show all 22Show fewer
  • History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological disease
  • Signs and symptoms of eczema herpeticum within the preceding 12 months or cellulitis within preceding 3 months
  • Positive results for HIV infection at screening
  • History or clinical manifestations of significant neurological (e.g., epilepsy) or psychiatric disorders (e.g., history of suicide attempt; history of psychiatric episodes resulting in hospitalization)
  • An active intercurrent infection
  • History of clinically significant hypersensitivity, anaphylaxis, or allergies to any drug compound, which resulted in a severe adverse event
  • Liver function tests (ALT, AST) >1.25 times the upper limit of normal at Screening. (refer to Covance Lab Manual for reference ranges) Note: Under no circumstances should a patient who did not qualify regarding liver function tests (ALT and/or AST) be re-screened and/or re-qualified
  • Patient has any acute or chronic condition or prior therapy that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this clinical study or otherwise would make the patient unsuitable for this study
  • Patient has a history of drug abuse within 1 year prior to Day 1
  • Patient consumes excess amounts of alcohol, defined as exceeding an average of 14 drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor, or any combination of them) within 2 months prior to Day -14 (beginning of single-blind period) or is unwilling to comply with the restricted use of alcohol (as defined above, no more than 14 drinks/week) from screening, throughout the study, and until study completion (follow-up visit).
  • Patient uses any prohibited concomitant medications at any time during the study
  • Patient is pregnant or lactating or intends to become pregnant or, in the case of a male patient, intends to father a child during the study period and for 2 weeks after the last dose of study medication
  • Patient has poor peripheral venous access that may limit blood sampling for clinical laboratory or pharmacokinetic analysis
  • Patient has participated in any other investigational study drug or device trial in which receipt of an investigational study drug or device occurred within 8 weeks prior to Day 1
  • Prior exposure to S-777469
  • Any reason which, in the opinion of the Investigator, interferes with the ability of the patient to participate in or complete the trial

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

United States33 sites

  • Study site

    Alpharetta, Georgia, 30022

  • Study site

    Arlington Heights, Illinois, 60005

  • Study site

    Austin, Texas, 78759

  • Study site

    Berlin, New Jersey, 08009

  • Study site

    Boise, Idaho, 83704

  • Study site

    College Station, Texas, 77845

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Dallas, Texas, 75230

  • Study site

    Denver, Colorado, 80210

  • Study site

    Evansville, Indiana, 47713

  • Study site

    Fridley, Minnesota, 55432

  • Study site

    Goodlettsville, Tennessee, 37072

  • Study site

    Hot Springs, Arkansas, 71913

  • Study site

    Houston, Texas, 77058

  • Study site

    Johnston, Rhode Island, 02919

  • Study site

    Knoxville, Tennessee, 37934

  • Study site

    Lake Oswego, Oregon, 97035

  • Study site

    Los Angeles, California, 90045

  • Study site

    Lynchburg, Virginia, 24501

  • Study site

    Norfolk, Virginia, 23507

  • Study site

    Oceanside, California, 92056

  • Study site

    Omaha, Nebraska, 68144

  • Study site

    Paramus, New Jersey, 07652

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Portland, Oregon, 97210

  • Study site

    Portland, Oregon, 97223

  • Study site

    Portland, Oregon, 973239

  • Study site

    Riverside, California, 92506

  • Study site

    San Antonio, Texas, 78229

  • Study site

    South Bend, Indiana, 46617

  • Study site

    Stony Brook, New York, 11790

  • Study site

    West Jordan, Utah, 84088

  • Study site

    West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of 2 Doses of S-777469 (400 mg BID and 800 mg BID) in Patients With Atopic Dermatitis

The purpose of this study is to evaluate the safety and efficacy of 2 doses of S-777469 in patients with atopic dermatitis.

Being tested
S-777469 400 mg, S-777469 800 mg, Placebo
Keywords
Atopic Dermatitis
Medical subject headings
Dermatitis, Atopic

What participants receive

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

  • S-777469 400 mgDrug

    S-777469 400 mg BID

  • S-777469 800 mgDrug

    S-777469 800 mg BID

  • PlaceboDrug

    Placebo BID

Study groups in NCT00703573
Study groupRoleWhat they receive
Group AExperimentalS-777469 400 mg BID (two 200 mg tablets of S-777469 and two tablets of placebo BID)
Receives: Drug: S-777469 400 mg; Drug: Placebo
Group BExperimentalS-777469 800 mg BID (four 200 mg tablets of S-777469 BID)
Receives: Drug: S-777469 800 mg
Group CPlacebo comparatorPlacebo BID (four tablets of placebo BID)
Receives: Drug: Placebo

What is being measured

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

  1. Efficacy of S-777469 was assessed by Physician's Global Assessment (PGA) and Numerical Rating Scale (NRS)

    Physician's Global Assessment

    Measured: Change from baseline to 12 weeks

  2. Safety was assessed by repeated clinical evaluation and evaluation of treatment-emergent adverse events. It included vital signs, medical history, concomitant medications, physical examination, 12-lead ECGs, and standard clinical laboratory safety tests

    Safety, determined by Adverse event frequency and changes in laboratory values

    Measured: Baseline to 12 weeks

Secondary outcomes (2)

  1. Efficacy was assessed by PGA, NRS, Behavioral Rating Scale, Eczema Area and Severity Index Score, Investigator panel treatment-blind comparative review ratings of digital photography of affected areas, and Thymus and Activation-Regulated Chemokine

    Assessment of PGA, NRS, Behavioral Rating Scale, Eczema Area and Severity Index Score, Investigator panel treatment-blind comparative review ratings of digital photography of affected areas, and Thymus and Activation-Regulated Chemokine

    Measured: Changes from baseline to various pre-defined time-points during the 12 week study

  2. Pharmacokinetic analysis of the concentration of unchanged parent drug (S-777469) in trough samples

    The concentration of S-777469 will be evaluated to determine when steady state is achieved

    Measured: From Baseline during Week 1

Timeline

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

  1. First posted23 Jun 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionMay 2009
  4. Study completionDec 2009

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00703573
Sponsor's protocol ID
0721D1424
Status last verified
May 2018
First submitted
20 Jun 2008
Last updated
8 May 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S-777469 400 mg and S-777469 800 mg in people with Atopic Dermatitis, run by Shionogi at 33 sites 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 0 inclusion and 22 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 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites 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. Some participants in this study may receive a placebo. 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?

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?

Efficacy of S-777469 was assessed by Physician's Global Assessment (PGA) and Numerical Rating Scale (NRS) (time frame: Change from baseline to 12 weeks). 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 NCT00703573.

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 8 May 2018.

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Clinical Trial NCT00703573 | AzTrials