Atopic DermatitisPhase 2IGUANANCT03568071
A Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics (PK)/Pharmacodynamics (PD) of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing MOR 106 in people with Atopic Dermatitis, run by Lakefront Biotherapeutics NV at 53 sites in 5 countries.
Trial summary
This is a Phase II, randomized, double-blind, placebo-controlled multicenter study of repeated doses of MOR106 administered as IV infusion. MOR106, is an antibody which is being developed as a treatment for diseases such as psoriasis and 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?
- MOR 106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 53 sitesin 5 countries
- Study dates
- 26 Apr 2018to 3 Mar 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between 18-65 years of age (extremes included), on the day of signing informed consent form (ICF).
- Able and willing to give voluntary written informed consent and meet all of the inclusion criteria and none of the exclusion criteria before being enrolled in the study. The subjects must sign the informed consent form prior to any study-related procedures and agree to the schedule of assessments.
- A body mass index (BMI) between ≥18 and ≤30 kg/m².
- Diagnosis of chronic atopic dermatitis with at least 1 year since first diagnosis, as per the Hanifin and Rajka Criteria, fulfilling the following criteria:
- EASI ≥12 at screening and ≥16 at baseline (Day 1 pre-dose).
- Investigator's Global Assessment (IGA) score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and at baseline.
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- Greater than or equal to 10% body surface area (BSA) of atopic dermatitis involvement at screening.
- Willingness to continue stable use of an additive free, basic, bland emollient twice daily for at least 7 days before baseline and throughout the study.
- Subject is a candidate for systemic therapy and has a history of inadequate response or has a contraindication to topical corticosteroids and/or topical calcineurin inhibitors before screening visit, as per investigator's opinion.
- Willing to adhere to the following contraceptive restrictions:
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening, and a negative urine pregnancy test at baseline.
- Female subjects of childbearing potential must use a highly effective method of contraception from 28 days prior to the first dose of study drug, during the study, and for at least 24 weeks after the last dose of study drug.
- Non-vasectomized male subjects with a female partner of childbearing potential must agree to a highly effective form of contraception during the study, and for at least 24 weeks after last dose of study drug.
- All male subjects must agree to use a condom from the first dose of Investigational Medicinal Product (IMP), during the study and for at least 24 weeks after the last dose of IMP.
Who cannot join
- Known hypersensitivity to study drug ingredients or history of any significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
- Prior treatment with MOR106.
- Positive serology for hepatitis B (positive hepatitis B surface [HBs] antigen and/or positive hepatitis core antibody [HBc]), or hepatitis C virus (HCV) antibody or any history of hepatitis from any cause with the exception of hepatitis A. Subjects who are immune to hepatitis B because of vaccination can be included.
- History of or current immunosuppressive condition (e.g., human immunodeficiency virus [HIV] infection), including history of invasive opportunistic infections (e.g., TB, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite infection resolution or unusually frequent, recurrent, or prolonged infections, per investigator judgment.
- Subjects with a history of Varicella zoster virus who experienced any episode or recurrence of Herpes Zoster infection within 1 year of screening or ≥ one episode or Herpes Zoster within 1 year of screening must be excluded. (A history of Herpes simplex types 1 and 2 and vaginal candidiasis are permitted.)
- Pregnant or breast feeding female or subject is intending to become pregnant or breastfeed.
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- Any concurrent illness, condition, disability, or clinically significant abnormality (including laboratory tests, ≥ New York Heart Association Classification (NYHA) III/IV) or clinically significant illness in the 3 months prior to initial study drug administration that, in the investigator's opinion, represents a safety risk for the subject's participation in the study, may affect the interpretation of clinical safety or efficacy data, or may prevent the subject from safely completing the assessments required by the protocol.
- Any of the following laboratory findings:
- White blood cell count <3.0 x 109 cells/L
- Neutrophil count <1.5 x 109 cells/L
- Platelet count <100 x 109 cells/L
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 x upper limit of normal (ULN)
- History of malignancy within the past 5 years prior to screening with the exception of non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or of the breast, prostate cancer T1a or T1b using the TNM (tumour, nodes, metastasis) clinical staging system.
- Clinically significant abnormalities at the discretion of the investigator detected on vital signs or physical examination (other than atopic dermatitis) at screening or baseline (Day 1 pre-dose).
- History of eczema herpeticum in the last 12 months prior to screening.
- Subjects who have had an attenuated vaccination within 4 weeks of baseline or are expected to have one during the course of the study.
- Participation in another experimental therapy study within 5 times the half-life (if known) or 12 weeks (if not known) of the experimental therapy, prior to baseline, or current enrollment in any other interventional study.
- Having used any of the following treatments:
- Exposure to a biologic therapy for atopic dermatitis
- Immunosuppressive/ immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon-gamma, azathioprine, methotrexate) within 4 weeks of baseline
- Phototherapy (ultraviolet [UV] B or psoralen and ultraviolet A [PUVA]) for atopic dermatitis within 4 weeks of baseline
- Treatment with topical corticosteroids or topical calcineurin inhibitors within 2 weeks of baseline
- Treatment with biologics (for non atopic dermatitis indications within 5 half-lives (if known) or 12 weeks prior to baseline (if unknown)
- Regular use (more than 2 visits per week) of a tanning booth/parlour within 4 weeks of screening
- Active chronic or acute infection requiring treatment with systemic (oral, SC or IV) antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals, within 4 weeks of baseline, or clinical signs of infective eczema within 1 week before baseline. Note: subjects may be rescreened after infection resolves.
- Investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof, who is directly involved in the conduct of the study.
- Not able to manage the electronic diary (e-diary) as per assessment of the investigator.
Trial locations and contacts
53 sites in 5 countries.
53 sites in 5 countries
Poland27 sites
CERMED
Bialystok
Antoni Jurasz Universiti Hospital Nº1
Bydgoszcz
NZOZ Centrum Medyczne KERmed
Bydgoszcz
A-DERM-SERWIS NZOZ , Przychodnia Specjalistyczna
Częstochowa
Centrum Badań Klinicznych PI-House
Gdansk
Gyncentrum
Katowice
Centrum Medyczne ALL-MED
Krakow
Diamond Clinic
Krakow
Medical Center Dietla 19
Krakow
NZOZ Centrum Medyczne proMimed
Krakow
ETG Łódź
Lodz
KLIMED Marek Klimkiewicz
Łomża
Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz
Lublin
Samodzielny Publiczny Szpital Kliniczny nr 1 Katedra i Klinika Dermatologii, Wenerologii i Dermatologii Dziecięcej
Lublin
Labderm sc Beata Bergler-Czop Barbara Sido-Bergler
Ossy, 42-624
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski
Ostrowieckie Centrum Medyczne
Ostrowiec Świętokrzyski
KLIMED Marek Klimkiewicz
Piotrkow Trybunalski, 93-700
Centrum Badan Klinicznych S.C.
Poznan
Centrum Medyczne Grunwald
Poznan
Clinical Research Center Sp. z o.o. Medic-R Spółka Komandytowa
Poznan
ETG Skierniewice
Skierniewice
Centrum Medyczne AMED
Warsaw
Clinical Research Group
Warsaw
ETG Warszawa
Warsaw
4HEALTH
Wroclaw
Dobrostan
Wroclaw
Germany16 sites
Fachklinik Bad Bentheim, Department of Dermatology
Bad Bentheim
Korsearch. Studienzentrum
Berlin, 13086
Charite, Universitätsmedizin Berlin, Centrum 12, Klinik für Dermatologie, Venerologie und Allergologie
Berlin
Hautarztpraxis im Jahrhunderthaus
Bochum
Hauttumorzentrum Ruhr- Universität Bochum
Bochum
RuhrDerm - Studienzentrum der Gemeinschaftspraxis für Dermatologie, Venerologie, Allergologie, Phlebologie
Bochum
Elbe Klinikum Buxtehude
Buxtehude
Universitätsklinikum Frankfurt, Klinik für Dermatologie
Frankfurt
SCIderm GmbH (a company of TFS group)
Hamburg
Universitätsklinikum Heidelberg, Hautklinik
Heidelberg
Institut für Entzündungsmedizin
Lübeck
Clinical research center (CRC), Department of Dermatology
Mainz
Klinik und Poliklinik der Dermatologie und Allergologie der Universität München
München
Technical University Munich, Department of Dermatology
Munich
University Hospital of Muenster, Dpt. of Dermatology
Münster
Haut- und Lasercentrum Potsdam
Potsdam
Hungary5 sites
Budai Irgalmasrendi Kórház (St. John Hospital)
Budapest
Semmelweis Egyetem Bőrgyógyászati Klinika
Budapest
Bács-Kiskun Megyei Kórház Bőrgyógyászati Osztály
Kecskemét
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
Miskolc
Szegedi Egyetem Bőrgyógyászati és Allergológiai Klinika
Szeged
United Kingdom4 sites
Whipps Cross Hospital
Leytonstone
Plymouth Hospitals NHS Trust
Plymouth
Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital
Sheffield
The Royal London Hospital
Whitechapel
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Repeated-dose Study to Evaluate the Efficacy, Safety, Tolerability,and PK/PD of Intravenously Administered MOR106 in Adult Subjects With Moderate to Severe Atopic Dermatitis
This is a Phase II, randomized, double-blind, placebo-controlled multicenter study of repeated doses of MOR106 administered as IV infusion. MOR106, is an antibody which is being developed as a treatment for diseases such as psoriasis and atopic dermatitis. An antibody is a protein that is made by the body in a defense reaction against viruses and bacteria or other small particles. In this case, MOR106 will act against IL-17C interleukin by binding to it. This way it could be possible to act against these diseases.
- Conditions
- Atopic Dermatitis
- Being tested
- MOR 106, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOR 106Drug
The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human IL-17C.
PlaceboDrug
A sodium chloride infusion container with IV solution without addition of MOR106 drug product will be used as placebo in the proposed clinical study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - dose regimen A | Experimental | MOR106 will be administered as IV infusion. Subjects will receive repeated doses of MOR106 over a 12-week treatment period. A loading dose (dose regimen A) will be administered on Day 1. Receives: Drug: MOR 106 |
| Cohort B - dose regimen B | Experimental | MOR106 will be administered as IV infusion. Subjects will receive repeated doses of MOR106 over a 12-week treatment period. A loading dose (dose regimen B) will be administered on Day 1. Receives: Drug: MOR 106 |
| Cohort C - dose regimen C | Experimental | MOR106 will be administered as IV infusion. Subjects will receive repeated doses of MOR106 over a 12-week treatment period. A loading dose (dose regimen C) will be administered on Day 1. Receives: Drug: MOR 106 |
| Cohort D - dose regimen D | Experimental | MOR106 will be administered as IV infusion. Subjects will receive alternating repeated doses of MOR106 or placebo over a 12-week treatment period. A loading dose (dose regimen D) will be administered on Day 1. Receives: Drug: MOR 106 |
| Cohort E - dose regimen E | Experimental | MOR106 will be administered as IV infusion.Subjects will receive alternating repeated doses of MOR106 or placebo over a 12-week treatment period. A loading dose (dose regimen E) will be administered on Day 1. Receives: Drug: MOR 106 |
| Placebo | Placebo comparator | Subjects will receive repeated doses of placebo over a 12-week treatment period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in Eczema Area and Severity Index (EASI) score.
To assess the clinical efficacy of repeated IV doses of MOR106 as assessed by percentage change from baseline in EASI score at Day 85 visit. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.
Measured: From baseline to Day 85
Secondary outcomes (31)
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.
To assess the clinical efficacy of repeated IV doses of MOR106. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.
Measured: From baseline to Day 85
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.
To assess the clinical efficacy of repeated IV doses of MOR106. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.
Measured: At Day 1
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.
To assess the clinical efficacy of repeated IV doses of MOR106. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.
Measured: At Day 15
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.
To assess the clinical efficacy of repeated IV doses of MOR106. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.
Measured: At Day 29
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.
To assess the clinical efficacy of repeated IV doses of MOR106. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.
Measured: At Day 43
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.
To assess the clinical efficacy of repeated IV doses of MOR106. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.
Measured: At Day 57
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.
To assess the clinical efficacy of repeated IV doses of MOR106. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.
Measured: At Day 71
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1.
To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Day 85
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1.
To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Day 1
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1.
To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Day 15
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1.
To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Day 29
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1.
To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Day 43
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1.
To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Day 57
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1.
To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Day 71
Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2.
To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Day 85
Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2.
To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Day 1
Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2.
To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Day 15
Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2.
To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Day 29
Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2.
To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Day 43
Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2.
To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Day 57
Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2.
To assess the clinical efficacy of repeated IV doses of MOR106.The IGA is an assessment scale to determine severity of atopic dermatitis and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Day 71
Percent change in Scoring Atopic Dermatitis (SCORAD) score.
To assess the clinical efficacy of repeated IV doses of MOR106. The SCORAD evaluates the extent of atopic dermatitis and ranges between 0 and 103. Higher values represent a worse outcome.
Measured: From baseline to Day 85
Percent change in Scoring Atopic Dermatitis (SCORAD) score.
To assess the clinical efficacy of repeated IV doses of MOR106. The SCORAD evaluates the extent of atopic dermatitis and ranges between 0 and 103. Higher values represent a worse outcome.
Measured: At Day 1
Percent change in Scoring Atopic Dermatitis (SCORAD) score.
To assess the clinical efficacy of repeated IV doses of MOR106. The SCORAD evaluates the extent of atopic dermatitis and ranges between 0 and 103. Higher values represent a worse outcome.
Measured: At Day 15
Percent change in Scoring Atopic Dermatitis (SCORAD) score.
To assess the clinical efficacy of repeated IV doses of MOR106. The SCORAD evaluates the extent of atopic dermatitis and ranges between 0 and 103. Higher values represent a worse outcome.
Measured: At Day 29
Percent change in Scoring Atopic Dermatitis (SCORAD) score.
To assess the clinical efficacy of repeated IV doses of MOR106. The SCORAD evaluates the extent of atopic dermatitis and ranges between 0 and 103. Higher values represent a worse outcome.
Measured: At Day 43
Percent change in Scoring Atopic Dermatitis (SCORAD) score.
To assess the clinical efficacy of repeated IV doses of MOR106. The SCORAD evaluates the extent of atopic dermatitis and ranges between 0 and 103. Higher values represent a worse outcome.
Measured: At Day 57
Percent change in Scoring Atopic Dermatitis (SCORAD) score.
To assess the clinical efficacy of repeated IV doses of MOR106. The SCORAD evaluates the extent of atopic dermatitis and ranges between 0 and 103. Higher values represent a worse outcome.
Measured: At Day 71
The number of incidents of Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs), and discontinuations due to Adverse Events (AEs).
To assess the safety and tolerability of repeated IV doses of MOR106.
Measured: From screening up to Day 197/early discontinuation (ED) visit
Characterization of the MOR106 immunogenetic profile.
To assess the immunogenicity of repeated IV doses of MOR106.
Measured: From baseline through Day 197/ED visit
MOR106 (AUC0-inf)
To characterize the PK of repeated IV doses of MOR106.
Measured: From baseline through Day 197/ED visit
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 start26 Apr 2018
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
Why it stopped: MOR106 clinical development in atopic dermatitis was stopped for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helen Timmis, MBChB MICR, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568071
- Sponsor's protocol ID
- MOR106-CL-201
- Other IDs
- 2017-001142-10, 2017
- Acronym
- IGUANA
- Status last verified
- Mar 2020
- First submitted
- 31 May 2018
- Last updated
- 18 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled Repeated-dose Study to Evaluate the Efficacy, Safety, Tolerability,and PK/PD of Intravenously Administered MOR106 in Adult Subjects With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03568071
- Acronym / sponsor ID
- IGUANA / MOR106-CL-201
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: MOR106 clinical development in atopic dermatitis was stopped for futility
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 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.
This is a Phase II, randomized, double-blind, placebo-controlled multicenter study of repeated doses of MOR106 administered as IV infusion. MOR106, is an antibody which is being developed as a treatment for diseases such as psoriasis and atopic dermatitis. An antibody is a protein that is made by the body in a defense reaction against viruses and bacteria or other small particles. In this case, MOR106 will act against IL-17C interleukin by binding to it. This way it could be possible to act against these diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort A - dose regimen A | Experimental | Drug: MOR 106MOR106 will be administered as IV infusion. Subjects will receive repeated doses of MOR106 over a 12-week treatment period. A loading dose (dose regimen A) will be administered on Day 1. |
| Cohort B - dose regimen B | Experimental | Drug: MOR 106MOR106 will be administered as IV infusion. Subjects will receive repeated doses of MOR106 over a 12-week treatment period. A loading dose (dose regimen B) will be administered on Day 1. |
| Cohort C - dose regimen C | Experimental | Drug: MOR 106MOR106 will be administered as IV infusion. Subjects will receive repeated doses of MOR106 over a 12-week treatment period. A loading dose (dose regimen C) will be administered on Day 1. |
| Cohort D - dose regimen D | Experimental | Drug: MOR 106MOR106 will be administered as IV infusion. Subjects will receive alternating repeated doses of MOR106 or placebo over a 12-week treatment period. A loading dose (dose regimen D) will be administered on Day 1. |
| Cohort E - dose regimen E | Experimental | Drug: MOR 106MOR106 will be administered as IV infusion.Subjects will receive alternating repeated doses of MOR106 or placebo over a 12-week treatment period. A loading dose (dose regimen E) will be administered on Day 1. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive repeated doses of placebo over a 12-week treatment period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female between 18-65 years of age (extremes included), on the day of signing informed consent form (ICF).
- Able and willing to give voluntary written informed consent and meet all of the inclusion criteria and none of the exclusion criteria before being enrolled in the study. The subjects must sign the informed consent form prior to any study-related procedures and agree to the schedule of assessments.
- A body mass index (BMI) between ≥18 and ≤30 kg/m².
- Diagnosis of chronic atopic dermatitis with at least 1 year since first diagnosis, as per the Hanifin and Rajka Criteria, fulfilling the following criteria:
- Willing to adhere to the following contraceptive restrictions:
Key exclusion criteria (27 listed)
- Known hypersensitivity to study drug ingredients or history of any significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
- Prior treatment with MOR106.
- Positive serology for hepatitis B (positive hepatitis B surface [HBs] antigen and/or positive hepatitis core antibody [HBc]), or hepatitis C virus (HCV) antibody or any history of hepatitis from any cause with the exception of hepatitis A. Subjects who are immune to hepatitis B because of vaccination can be included.
- History of or current immunosuppressive condition (e.g., human immunodeficiency virus [HIV] infection), including history of invasive opportunistic infections (e.g., TB, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite infection resolution or unusually frequent, recurrent, or prolonged infections, per investigator judgment.
- Subjects with a history of Varicella zoster virus who experienced any episode or recurrence of Herpes Zoster infection within 1 year of screening or ≥ one episode or Herpes Zoster within 1 year of screening must be excluded. (A history of Herpes simplex types 1 and 2 and vaginal candidiasis are permitted.)
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 |
|---|---|---|
| MOR 106The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human IL-17C. | Drug | Cohort A - dose regimen A, Cohort B - dose regimen B, Cohort C - dose regimen C, Cohort D - dose regimen D, Cohort E - dose regimen E |
| PlaceboA sodium chloride infusion container with IV solution without addition of MOR106 drug product will be used as placebo in the proposed clinical study. | Drug | Placebo |
Primary outcome
Percent change in Eczema Area and Severity Index (EASI) score.
Time frame: From baseline to Day 85
To assess the clinical efficacy of repeated IV doses of MOR106 as assessed by percentage change from baseline in EASI score at Day 85 visit. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.
31 secondary outcomes
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.
Time frame: From baseline to Day 85
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.
Time frame: At Day 1
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.
Time frame: At Day 15
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.
Time frame: At Day 29
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.
Time frame: At Day 43
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.
Time frame: At Day 57
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score.
Time frame: At Day 71
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1.
Time frame: At Day 85
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1.
Time frame: At Day 1
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1.
Time frame: At Day 15
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1.
Time frame: At Day 29
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1.
Time frame: At Day 43
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1.
Time frame: At Day 57
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1.
Time frame: At Day 71
Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2.
Time frame: At Day 85
Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2.
Time frame: At Day 1
Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2.
Time frame: At Day 15
Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2.
Time frame: At Day 29
Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2.
Time frame: At Day 43
Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2.
Time frame: At Day 57
Proportion of subjects who achieve Investigators' Global Assessment (IGA) score reduction of ≥2.
Time frame: At Day 71
Percent change in Scoring Atopic Dermatitis (SCORAD) score.
Time frame: From baseline to Day 85
Percent change in Scoring Atopic Dermatitis (SCORAD) score.
Time frame: At Day 1
Percent change in Scoring Atopic Dermatitis (SCORAD) score.
Time frame: At Day 15
Percent change in Scoring Atopic Dermatitis (SCORAD) score.
Time frame: At Day 29
Percent change in Scoring Atopic Dermatitis (SCORAD) score.
Time frame: At Day 43
Percent change in Scoring Atopic Dermatitis (SCORAD) score.
Time frame: At Day 57
Percent change in Scoring Atopic Dermatitis (SCORAD) score.
Time frame: At Day 71
The number of incidents of Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs), and discontinuations due to Adverse Events (AEs).
Time frame: From screening up to Day 197/early discontinuation (ED) visit
Characterization of the MOR106 immunogenetic profile.
Time frame: From baseline through Day 197/ED visit
MOR106 (AUC0-inf)
Time frame: From baseline through Day 197/ED visit
Results and safety
The study was stopped early (reason given: MOR106 clinical development in atopic dermatitis was stopped for futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
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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.
Helen Timmis, MBChB MICR study director
Lakefront Biotherapeutics NV
53 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MOR 106 in people with Atopic Dermatitis, run by Lakefront Biotherapeutics NV at 53 sites in 5 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 14 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: stopped early, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in Poland, Germany, Hungary, United Kingdom, Slovakia. 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 was stopped early (reason given: MOR106 clinical development in atopic dermatitis was stopped for futility). 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?
Percent change in Eczema Area and Severity Index (EASI) score. (time frame: From baseline to Day 85). 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 18 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.