Dermatitis, AtopicPhase 2Secu_in_ADNCT03568136
Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis
A Phase 2 study testing Secukinumab 300 mg in people with Dermatitis, Atopic and Eczema, Atopic, run by GWT-TUD GmbH at 5 sites in Germany.
Trial summary
The overall aim of this study is to assess the effects of a new treatment called Secukinumab in adults suffering from moderate to severe atopic dermatitis. Furthermore, the study shall support the extension of the approval for Secukinumab from psoriasis to atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dermatitis, Atopic, Eczema, Atopic, Neurodermatitis, Atopic
- What is being tested?
- Secukinumab 300 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 5 sitesGermany
- Study dates
- 18 Sep 2018to 4 May 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Atopic dermatitis (intrinsic disease without IgE mediated sensitization defined by negative history and negative SX-1 CAP FEIA or extrinsic disease defined by positive history and / or positive SX-1 CAP FEIA),
- SCORAD index score ≥ 25,
- EASI ≥ 16,
- Male and female patients at the age of 18 to 85 years,
- Signed Informed Consent,
- Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed,
- Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, and physical examination,
- Patients with stable chronic asthma, treated with inhaled corticosteroids, will be allowed to participate.
Who cannot join
- Other inflammatory skin disease than atopic dermatitis,
- Use of cyclosporine, azathioprine, mycophenolate [wash-out period of 4 weeks]; Phototherapy (PUVA, NB-UVB, UVA1; [wash-out period of 2 weeks]), Dupilumab (Dupixent®; [wash-out period of 12 weeks])
- Subjects expected to be exposed to an undue safety risk if participating in the trial including chronic infections,
- Contraindications of Secukinumab by label (i.e. approval for the treatment of psoriasis in the EU - refer to point 14 - 16 at the bottom of this section),
- Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial,
- Plans for administration of live vaccines during the study period,
Show all 27Show fewer
- Chronic infection,
- Patients with instable chronic asthma,
- Any chronic inflammatory bowel disease (e.g. Crohn's disease),
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>10 mIU/mL),
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 20 weeks after stopping treatment. Effective contraception is defined as either:
- Barrier method: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide (where available). Spermicides alone are not a barrier method of contraception and should not be used alone,
- The following methods are considered more effective than the barrier method and are also acceptable:
- Total abstinence: When this is in line with the preferred and usual lifestyle of the subject (Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception),
- Female sterilization: have had a surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment,
- Male partner sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject,
- Use of established oral, injected or implanted hormonal methods of contraception, intrauterine device (IUD) or intrauterine system (IUS) NOTE: Women are considered post-menopausal and not of child bearing potential if they have had:
- 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or • six months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL
- Or
- Surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening,
- Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit (a report ≤ 6 months is also accepted),
- History of alcohol or drug abuse within 1 year of the screening visit,
- Planned major surgical procedure during the patient's participation in this study,
- Hypersensitivity against Secukinumab,
- Active or reactive tuberculosis,
- Participation in other clinical studies.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Klinische Forschung Dresden GmbH
Dresden, 01069
Carl Gustav Carus University Hospital, Department of Dermatology
Dresden, 01307
SRH Wald-Klinikum Gera, Center for Clinical Studies
Gera, 07548
Hannover Medical School, Department for Dermatology, Allergy and Venereology
Hanover, 30625
SIBAmed Studienzentrum GmbH & Co KG
Leipzig, 04103
About this study
Official title: A Randomized, Placebo-controlled, Double-blind Study to Scrutinize the Efficacy of Secukinumab in Patients With Moderate to Severe Atopic Dermatitis
The overall aim of this study is to assess the effects of a new treatment called Secukinumab in adults suffering from moderate to severe atopic dermatitis. Furthermore, the study shall support the extension of the approval for Secukinumab from psoriasis to atopic dermatitis. The effectiveness of Secukinumab is determined on the reduction of the eczema score EASI 50 (Eczema Area and Severity Index, a tool to measure the severity of atopic dermatitis) at week 4.
Read the detailed description
Secukinumab is a humanized anti-IL-17A monoclonal antibody. Since Secukinumab is well established in the therapy of psoriasis with a highly favorable benefit to risk ration and IL-17 has been described in atopic dermatitis this study aims to investigate the effects of anti-IL-17 in atopic dermatitis.
This is a randomized, placebo-controlled, multicenter, double-blinded study to evaluate the efficacy and safety of subcutaneous Secukinumab compared to placebo in 45 adults with atopic dermatitis.
The study consists of 3 periods: a screening period of at least -14 days and up to -35 days, and a treatment period of 16 weeks and a follow-up period of additional 8 weeks. During the screening period eligibility of the patients is confirmed. Eligible patients are randomized 2:1 to treatment arm A or B at Day -7 (+2 to -15) during the randomization visit. Secukinumab (Cosentyx®) will be used according to the official label and SmPC (Summary of Product Characteristics). Patients in treatment arm A receive 300 mg Secukinumab administered as 2 subcutaneous injections of 150 mg (i.e. 2x 150 mg) at baseline day 1 and week 1, 2, 3, 4, 8, 12 and injections with placebo at week 5, 6, 7 and 16. For assessments of the study endpoints visits are performed at weeks 20 and 24. Placebo will be administered as 2 subcutaneous injections. Patients in treatment arm B receive placebo until visit 3 (week 3) and will switch to Secukinumab 300 mg s.c. up from visit 4 (week 4), visit 5, 6, 7, 8, 12 and16. For assessments of the study endpoints visits are performed at weeks 20 and 24.
- Conditions
- Dermatitis, Atopic, Eczema, Atopic, Neurodermatitis, Atopic
- Being tested
- Secukinumab 300 mg, Placebo
- Keywords
- neurodermatitis, moderate to severe inflammatory reaction of the skin, Skin and Connective Tissue Diseases
- Medical subject headings
- Dermatitis, Atopic, Neurodermatitis, Skin and Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secukinumab 300 mgDrug
Also called COSENTYX ®
Solution for injection in pre-filled syringe
PlaceboDrug
Also called Placebo (for Secukinumab)
Solution for injection in pre-filled syringe
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A | Experimental | Patients in treatment arm A receive 300 mg Secukinumab administered as 2 subcutaneous injections of 150 mg (i.e. 2x 150 mg) at baseline day 1 and week 1, 2, 3, 4, 8, 12 and injections with placebo at week 5, 6, 7 and 16. For assessments of the study endpoints were followed up visits at week 20 and 24. Placebo will be administered as 2 subcutaneous injections. Receives: Drug: Secukinumab 300 mg; Drug: Placebo |
| Treatment Arm B | Placebo comparator | Patients in treatment arm B receive placebo until visit 3 (week 3) and will switch to Secukinumab 300 mg s.c. up from visit 4 (week 4), visit 5, 6, 7, 8, 12 and16. For assessments of the study endpoints were followed up visits at week 20 and 24. Receives: Drug: Secukinumab 300 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in EASI
Proportion of patients with a reduction of the eczema score EASI of at least 50%. The proportions are then compared between study arms.
Measured: week 4 (visit 4)
Secondary outcomes (10)
Reduction of EASI
To compare the proportions of patients with a reduction of the eczema score EASI 50.
Measured: baseline (day 1, visit 0) and End of Trial (Arm A week 12 / Arm B week 16)
Reduction of EASI
To compare the number of patients with a reduction of the eczema score EASI 50.
Measured: Arm A week 12 / Arm B week 16
Reduction in SCORAD (Scoring atopic dermatitis)
The number of patients with a reduction of 50 % in SCORAD index.
Measured: day 1, week 4 and Arm A week 12 / Arm B week 16
Change in pruritus score (Visual Analogue Scale)
To compare the proportion of patients with change in pruritus score (VAS) by 50 %.
Measured: day 1, week 4 and Arm A week 12 / Arm B week 16
Change in IGA Score (5-point Investigator's Global Assessment)
To compare the proportion of patients who achieve a score of "clear-0" or "almost clear-1" in the static IGA score compared to baseline.
Measured: Arm A week 12 / Arm B week 16
Serum biomarkers CCL17 and CCL22
To compare the serum biomarkers CCL17 and CCL22.
Measured: day 1, week 4 and Arm A week 12 / Arm B week 16
Increase in DLQI (Dermatology Life Quality Index)
To compare the proportion of patients achieving increase in DLQI by 30 %.
Measured: day 1, week 4 and Arm A week 12 / Arm B week 16
Consumption of topical methylprednisolone aceponate
To evaluate the quantification of the consumption of topical methylprednisolone aceponate 0.1% in gram.
Measured: day 1, week 4 and Arm A week 12 / Arm B week 16
Serious and non-serious adverse drug reactions
To observe any serious adverse drug reactions and non-serious adverse drug reactions.
Measured: treatment phase (day 1 up to week 16), follow-up phase (week 20, week 24)
Gender distribution in patients with atopic dermatitis
Subgroup analyses will be performed to compare the effects of treatment with Secukinumab in male and female patients. Therefore, the recorded gender data will be used and separately analyzed for the above mentioned primary and secondary endpoints.
Measured: study arm A week 4 and both study arms week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start18 Sep 2018
- Primary completion4 May 2020
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Stefan Beissert, Prof. Dr., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568136
- Sponsor's protocol ID
- Secu_Trial
- Other IDs
- 2016-005181-57, 2016
- Acronym
- Secu_in_AD
- Status last verified
- May 2020
- First submitted
- 23 May 2018
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind Study to Scrutinize the Efficacy of Secukinumab in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03568136
- Acronym / sponsor ID
- Secu_in_AD / Secu_Trial
- Conditions
- Dermatitis, Atopic, Eczema, Atopic, Neurodermatitis, Atopic
- Keywords
- neurodermatitis, moderate to severe inflammatory reaction of the skin, Skin and Connective Tissue Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 26 Jun 2018 (actual)
- 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 overall aim of this study is to assess the effects of a new treatment called Secukinumab in adults suffering from moderate to severe atopic dermatitis. Furthermore, the study shall support the extension of the approval for Secukinumab from psoriasis to atopic dermatitis. The effectiveness of Secukinumab is determined on the reduction of the eczema score EASI 50 (Eczema Area and Severity Index, a tool to measure the severity of atopic dermatitis) at week 4.
Detailed description
Secukinumab is a humanized anti-IL-17A monoclonal antibody. Since Secukinumab is well established in the therapy of psoriasis with a highly favorable benefit to risk ration and IL-17 has been described in atopic dermatitis this study aims to investigate the effects of anti-IL-17 in atopic dermatitis.
This is a randomized, placebo-controlled, multicenter, double-blinded study to evaluate the efficacy and safety of subcutaneous Secukinumab compared to placebo in 45 adults with atopic dermatitis.
The study consists of 3 periods: a screening period of at least -14 days and up to -35 days, and a treatment period of 16 weeks and a follow-up period of additional 8 weeks. During the screening period eligibility of the patients is confirmed. Eligible patients are randomized 2:1 to treatment arm A or B at Day -7 (+2 to -15) during the randomization visit. Secukinumab (Cosentyx®) will be used according to the official label and SmPC (Summary of Product Characteristics). Patients in treatment arm A receive 300 mg Secukinumab administered as 2 subcutaneous injections of 150 mg (i.e. 2x 150 mg) at baseline day 1 and week 1, 2, 3, 4, 8, 12 and injections with placebo at week 5, 6, 7 and 16. For assessments of the study endpoints visits are performed at weeks 20 and 24. Placebo will be administered as 2 subcutaneous injections. Patients in treatment arm B receive placebo until visit 3 (week 3) and will switch to Secukinumab 300 mg s.c. up from visit 4 (week 4), visit 5, 6, 7, 8, 12 and16. For assessments of the study endpoints visits are performed at weeks 20 and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A | Experimental | Drug: Secukinumab 300 mg, Drug: PlaceboPatients in treatment arm A receive 300 mg Secukinumab administered as 2 subcutaneous injections of 150 mg (i.e. 2x 150 mg) at baseline day 1 and week 1, 2, 3, 4, 8, 12 and injections with placebo at week 5, 6, 7 and 16. For assessments of the study endpoints were followed up visits at week 20 and 24. Placebo will be administered as 2 subcutaneous injections. |
| Treatment Arm B | Placebo comparator | Drug: Secukinumab 300 mg, Drug: PlaceboPatients in treatment arm B receive placebo until visit 3 (week 3) and will switch to Secukinumab 300 mg s.c. up from visit 4 (week 4), visit 5, 6, 7, 8, 12 and16. For assessments of the study endpoints were followed up visits at week 20 and 24. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Atopic dermatitis (intrinsic disease without IgE mediated sensitization defined by negative history and negative SX-1 CAP FEIA or extrinsic disease defined by positive history and / or positive SX-1 CAP FEIA),
- SCORAD index score ≥ 25,
- EASI ≥ 16,
- Male and female patients at the age of 18 to 85 years,
- Signed Informed Consent,
Key exclusion criteria (27 listed)
- Other inflammatory skin disease than atopic dermatitis,
- Use of cyclosporine, azathioprine, mycophenolate [wash-out period of 4 weeks]; Phototherapy (PUVA, NB-UVB, UVA1; [wash-out period of 2 weeks]), Dupilumab (Dupixent®; [wash-out period of 12 weeks])
- Subjects expected to be exposed to an undue safety risk if participating in the trial including chronic infections,
- Contraindications of Secukinumab by label (i.e. approval for the treatment of psoriasis in the EU - refer to point 14 - 16 at the bottom of this section),
- Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial,
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 |
|---|---|---|
| Secukinumab 300 mgAlso: COSENTYX ®Solution for injection in pre-filled syringe | Drug | Treatment Arm A, Treatment Arm B |
| PlaceboAlso: Placebo (for Secukinumab)Solution for injection in pre-filled syringe | Drug | Treatment Arm A, Treatment Arm B |
Primary outcome
Reduction in EASI
Time frame: week 4 (visit 4)
Proportion of patients with a reduction of the eczema score EASI of at least 50%. The proportions are then compared between study arms.
10 secondary outcomes
Reduction of EASI
Time frame: baseline (day 1, visit 0) and End of Trial (Arm A week 12 / Arm B week 16)
Reduction of EASI
Time frame: Arm A week 12 / Arm B week 16
Reduction in SCORAD (Scoring atopic dermatitis)
Time frame: day 1, week 4 and Arm A week 12 / Arm B week 16
Change in pruritus score (Visual Analogue Scale)
Time frame: day 1, week 4 and Arm A week 12 / Arm B week 16
Change in IGA Score (5-point Investigator's Global Assessment)
Time frame: Arm A week 12 / Arm B week 16
Serum biomarkers CCL17 and CCL22
Time frame: day 1, week 4 and Arm A week 12 / Arm B week 16
Increase in DLQI (Dermatology Life Quality Index)
Time frame: day 1, week 4 and Arm A week 12 / Arm B week 16
Consumption of topical methylprednisolone aceponate
Time frame: day 1, week 4 and Arm A week 12 / Arm B week 16
Serious and non-serious adverse drug reactions
Time frame: treatment phase (day 1 up to week 16), follow-up phase (week 20, week 24)
Gender distribution in patients with atopic dermatitis
Time frame: study arm A week 4 and both study arms week 16
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 3 May 2021.
- Individual participant dataSharing planned: No
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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.
Stefan Beissert, Prof. Dr. principal investigator
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 Secukinumab 300 mg in people with Dermatitis, Atopic and Eczema, Atopic, run by GWT-TUD GmbH 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 8 inclusion and 27 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 3 May 2021. 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?
Reduction in EASI (time frame: week 4 (visit 4)). 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 3 May 2021.