Pruritus in Patients With Atopic DermatitisPhase 2NCT01033097
Safety and Efficacy of DNK333 in Atopic Dermatitis Patients
A Phase 2 study testing DNK333 5 mg, DNK333 25 mg and DNK333 100 mg in people with Pruritus in Patients With Atopic Dermatitis, run by Novartis Pharmaceuticals at 5 sites in Germany.
Trial summary
This study will assess the safety and efficacy of DNK333 in patients with atopic dermatitis suffering from pruritus, who require systemic treatment of the disease. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pruritus in Patients With Atopic Dermatitis
- What is being tested?
- DNK333 5 mg, DNK333 25 mg and DNK333 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 5 sitesGermany
- Study dates
- Nov 2009to Jul 2011
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female atopic dermatitis patients,18 to 60 years of age inclusive, who fulfill the following criteria:
- Requirement of systemic therapy
- Itch VAS score higher than 50 mm
- EASI score higher than 8
Who cannot join
- Women of child-bearing potential who are not willing to use two highly effective methods of contraception are not allowed in the study. Similarly, men who are not willing to use two acceptable methods of contraception are not allowed in the study.
- Any systemic immunosuppressive treatment and/or phototherapy within 4 weeks prior to the first dosing.
- Use of any systemic antihistamines or topical corticosteroids within one week prior to first dosing and for the duration of the treatment period. Any other topical or oral treatment for atopic dermatitis (except emollients prescribed by the investigator) within 2 weeks prior to the first dosing will also be excluded.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Frankfurt
Novartis Investigator Site
Hanover
Novartis Investigative Site
Kiel
Novartis Investigative Site
Münster
About this study
Official title: A Multicenter, Randomized, Double-blinded, Placebo and Positive Controlled Study to Evaluate the Anti-pruritic Effect, Safety and Tolerability, Systemic and Skin Exposure, After 2 Weeks of Treatment With a Microemulsion Formulation of DNK333 in Atopic Dermatitis Patients
This study will assess the safety and efficacy of DNK333 in patients with atopic dermatitis suffering from pruritus, who require systemic treatment of the disease.
- Being tested
- DNK333 5 mg, Placebo to 5 mg, DNK333 25 mg, Placebo to 25 mg, DNK333 100 mg
- Keywords
- Dermatitis, inflammatory skin disease, itch, eczema
- Medical subject headings
- Dermatitis, Pruritus, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNK333 5 mgDrug
5 mg oral
Placebo to 5 mgDrug
5 mg placebo oral
DNK333 25 mgDrug
25 mg oral
Placebo to 25 mgDrug
25 mg placebo oral
DNK333 100 mgDrug
100 mg oral
Placebo to 100 mgDrug
100 mg placebo oral
Betamethasone 4 mgDrug
4 mg oral
DNK333 1mgDrug
1 mg oral
Placebo to 1mgDrug
1 mg placebo oral
| Study group | Role | What they receive |
|---|---|---|
| DNK333 5 mg | Experimental | Not described Receives: Drug: DNK333 5 mg |
| Placebo to DNK333 5mg | Placebo comparator | Not described Receives: Drug: Placebo to 5 mg |
| DNK333 25 mg | Experimental | Not described Receives: Drug: DNK333 25 mg |
| Placebo to DNK333 25 mg | Placebo comparator | Not described Receives: Drug: Placebo to 25 mg |
| DNK333 100 mg | Experimental | Not described Receives: Drug: DNK333 100 mg |
| Placebo to DNK333 100 mg | Placebo comparator | Not described Receives: Drug: Placebo to 100 mg |
| Betamethasone 4 mg | Active comparator | Not described Receives: Drug: Betamethasone 4 mg |
| DNK333 1 mg | Experimental | Not described Receives: Drug: DNK333 1mg |
| placebo 1mg | Placebo comparator | Not described Receives: Drug: Placebo to 1mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of DNK333 in reduction in pruritus in atopic dermatitis patients, as measured by actigraphy and visual analogue scale (VAS)
Measured: 2 weeks
Secondary outcomes (6)
Evaluate the therapeutic benefit from the patient's perspective of DNK333 to reduce pruritus as assessed by the Patient Benefit Index for Pruritus (PBIfP)
Measured: 2 weeks
Efficacy of DNK333 to reduce dermatitis as measured by the atopic dermatitis score and the Eczema Severity Index (EASI)
Measured: 2 weeks
Safety and tolerability of DNK333 in atopic dermatitis patients
Measured: 2 weeks
the plasma pharmacokinetics and skin exposure following treatment of atopic dermatitis patients with DNK333.
Measured: 2 weeks
Assess the health-related quality of life by using the Quality of Life for Atopic Dermatitis (QoLIAD) score.
Measured: 2 weeks
Compare the pharmacokinetics of DNK333 administered as an oral microemulsion drinking solution to a solid dispersion tablet in steady state.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pruritus in Patients With Atopic DermatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033097
- Sponsor's protocol ID
- CDNK333B2103
- Other IDs
- EudraCT 2009-012098-36
- Status last verified
- Mar 2017
- First submitted
- 15 Dec 2009
- Last updated
- 21 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blinded, Placebo and Positive Controlled Study to Evaluate the Anti-pruritic Effect, Safety and Tolerability, Systemic and Skin Exposure, After 2 Weeks of Treatment With a Microemulsion Formulation of DNK333 in Atopic Dermatitis Patients
- ClinicalTrials.gov ID
- NCT01033097
- Acronym / sponsor ID
- CDNK333B2103
- Keywords
- Dermatitis, inflammatory skin disease, itch, eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Dec 2009 (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.
This study will assess the safety and efficacy of DNK333 in patients with atopic dermatitis suffering from pruritus, who require systemic treatment of the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| DNK333 5 mg | Experimental | Drug: DNK333 5 mg |
| Placebo to DNK333 5mg | Placebo comparator | Drug: Placebo to 5 mg |
| DNK333 25 mg | Experimental | Drug: DNK333 25 mg |
| Placebo to DNK333 25 mg | Placebo comparator | Drug: Placebo to 25 mg |
| DNK333 100 mg | Experimental | Drug: DNK333 100 mg |
| Placebo to DNK333 100 mg | Placebo comparator | Drug: Placebo to 100 mg |
| Betamethasone 4 mg | Active comparator | Drug: Betamethasone 4 mg |
| DNK333 1 mg | Experimental | Drug: DNK333 1mg |
| placebo 1mg | Placebo comparator | Drug: Placebo to 1mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female atopic dermatitis patients,18 to 60 years of age inclusive, who fulfill the following criteria:
- Requirement of systemic therapy
- Itch VAS score higher than 50 mm
- EASI score higher than 8
Key exclusion criteria (4 listed)
- Women of child-bearing potential who are not willing to use two highly effective methods of contraception are not allowed in the study. Similarly, men who are not willing to use two acceptable methods of contraception are not allowed in the study.
- Any systemic immunosuppressive treatment and/or phototherapy within 4 weeks prior to the first dosing.
- Use of any systemic antihistamines or topical corticosteroids within one week prior to first dosing and for the duration of the treatment period. Any other topical or oral treatment for atopic dermatitis (except emollients prescribed by the investigator) within 2 weeks prior to the first dosing will also be excluded.
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| DNK333 5 mg5 mg oral | Drug | DNK333 5 mg |
| Placebo to 5 mg5 mg placebo oral | Drug | Placebo to DNK333 5mg |
| DNK333 25 mg25 mg oral | Drug | DNK333 25 mg |
| Placebo to 25 mg25 mg placebo oral | Drug | Placebo to DNK333 25 mg |
| DNK333 100 mg100 mg oral | Drug | DNK333 100 mg |
| Placebo to 100 mg100 mg placebo oral | Drug | Placebo to DNK333 100 mg |
| Betamethasone 4 mg4 mg oral | Drug | Betamethasone 4 mg |
| DNK333 1mg1 mg oral | Drug | DNK333 1 mg |
| Placebo to 1mg1 mg placebo oral | Drug | placebo 1mg |
Primary outcome
Efficacy of DNK333 in reduction in pruritus in atopic dermatitis patients, as measured by actigraphy and visual analogue scale (VAS)
Time frame: 2 weeks
6 secondary outcomes
Evaluate the therapeutic benefit from the patient's perspective of DNK333 to reduce pruritus as assessed by the Patient Benefit Index for Pruritus (PBIfP)
Time frame: 2 weeks
Efficacy of DNK333 to reduce dermatitis as measured by the atopic dermatitis score and the Eczema Severity Index (EASI)
Time frame: 2 weeks
Safety and tolerability of DNK333 in atopic dermatitis patients
Time frame: 2 weeks
the plasma pharmacokinetics and skin exposure following treatment of atopic dermatitis patients with DNK333.
Time frame: 2 weeks
Assess the health-related quality of life by using the Quality of Life for Atopic Dermatitis (QoLIAD) score.
Time frame: 2 weeks
Compare the pharmacokinetics of DNK333 administered as an oral microemulsion drinking solution to a solid dispersion tablet in steady state.
Time frame: 2 weeks
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 21 Mar 2017.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DNK333 5 mg, DNK333 25 mg and DNK333 100 mg in people with Pruritus in Patients With Atopic Dermatitis, run by Novartis Pharmaceuticals at 5 sites in Germany.
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 4 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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 DNK333 in reduction in pruritus in atopic dermatitis patients, as measured by actigraphy and visual analogue scale (VAS) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2017.