HealthyPhase 1NCT03689829
A Study to Test Safety, Tolerability, and the Way the Body Absorbs, Distributes, and Gets Rid of a Study Drug Called MOR106, in Healthy Subjects and in Patients With Moderate to Severe Atopic Dermatitis
A Phase 1 study testing MOR106 in people with Healthy and Atopic Dermatitis, run by Lakefront Biotherapeutics NV at 15 sites in 4 countries.
Trial summary
The clinical study consists of three parts: Part 1 with healthy volunteers. Part 2 and Part 3 including subjects with moderate to severe atopic dermatitis (a skin disease). For Part 1 the main goal of the study is to compare the safety, tolerability, and exposure of administration of the test drug via an injection in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Atopic Dermatitis
- What is being tested?
- MOR106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 13 Aug 2018to 2 Mar 2020
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1:
- Male between 18-50 years of age (extremes included), on the day of signing the informed consent form (ICF).
- Subjects between 65-88 kg (extremes included) with a body mass index (BMI) between 18-30 kg/m², inclusive.
- Judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and screening laboratory profile prior to the initial investigation medicinal product (IMP) administration.
- Part 2 and Part 3:
- Male or female between 18-65 years of age (extremes included), on the day of signing ICF.
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- A BMI between 18-30 kg/m², inclusive.
- Diagnosis of AD for at least one year since first diagnosis as per Hanifin and Rajka Criteria.
- EASI ≥ 12 at screening and ≥ 16 at the baseline visit (Day 1 predose)
- ≥ 10% BSA of AD involvement at screening.
- IGA score ≥ 3 (on 0-4 IGA scale).
- Willingness to use an additive free, basic, bland emollient twice daily for at least seven days before the baseline visit and throughout the study.
- Subject is a candidate for systemic therapy and is not responding adequately or has a contraindication to topical corticosteroids (TCS) and / or topical calcineurin inhibitors (TCI), per investigator's judgment.
Who cannot join
- Part 1, Part 2 and Part 3:
- Known hypersensitivity to IMP ingredients as determined by the investigator (such as, but not limited to, anaphylaxis requiring hospitalization).
- Prior treatment with MOR106.
- 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 three months prior to initial IMP 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.
- History of, or current immunosuppressive condition.
- In addition for Part 2 and 3:
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- Active chronic or acute skin infection requiring treatment with systemic (oral, sc or iv) antibiotics, antivirals or antifungals within 4 weeks of baseline, or clinical signs of infective eczema within 1 week before baseline (Day 1 pre-dose).
- Having used any of the following treatments:
- Exposure to a biologic therapy for AD. ii) Immunosuppressive/ immunomodulating drugs (e.g. systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon-γ (IFN-γ), azathioprine, methotrexate, etc.) within 4 weeks of baseline. iii) Phototherapy (ultraviolet (UVB) or Psoralen Ultraviolet A [PUVA]) for AD within four weeks of baseline. iv) Treatment with TCS or TCI within two weeks before the baseline visit. v) Treatment with biologics (for non-AD indications) within five half-lives (if known) or 12 weeks prior to baseline visit, whichever is longer. vi) Regular use (more than two visits per week) of a tanning booth/parlor within four weeks of the screening visit.
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Germany6 sites
Klinikum Augsburg Süd
Augsburg, 86179
Municipal Hospital Dessau
Dessau, 06847
University Hospital Carl Gustav Carus
Dresden, 1307
University Hospital Erlangen, Department of Dermatology
Erlangen, 91054
Medical Faculty University Clinic Magdeburg, University dermatology clinic
Magdeburg, 39120
Vest Clinic, Department of Dermatology and Allergy
Recklinghausen, 45657
Spain4 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Ramon y Cajal
Madrid, 28034
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital General Universitario de Valencia
Valencia, 46014
United Kingdom4 sites
MEU
Manchester
MeDiNova North London
Northwood, HA6 2RN
MeDiNova East London
Romford, RM1 3PJ
MeDiNova South London
Sidcup, DA14 6LT
About this study
Official title: A Parallel-design Phase 1 Study to Assess Safety, Tolerability and Pharmacokinetics/Exposure Following Different Single Dose Levels of MOR106 (Administered Subcutaneously or Intravenously) in Healthy Male Subjects (Randomized, Open-label), and in Subjects With Moderate to Severe Atopic Dermatitis (Randomized, Placebo-controlled, Double-blind, Repeated Subcutaneous Dosing Over 12 Weeks)
The clinical study consists of three parts:
- Part 1 with healthy volunteers.
- Part 2 and Part 3 including subjects with moderate to severe atopic dermatitis (a skin disease).
For Part 1 the main goal of the study is to compare the safety, tolerability, and exposure of administration of the test drug via an injection in a skin layer just under the surface (subcutaneous), to administration of the test drug into the vein (intravenous).
For Part 2 and Part 3 the main goal of the study is to assess the safety and tolerability of administration of the test drug via an injection in a skin layer just under the surface (subcutaneous) during 12 weeks of treatment.
- Conditions
- Healthy, Atopic Dermatitis
- Being tested
- MOR106, 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.
MOR106Drug
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 interleukin-17C (IL-17C).
PlaceboDrug
Corresponding placebo s.c. injections.
| Study group | Role | What they receive |
|---|---|---|
| MOR106 Single Dose A, i.v. infusion, Part 1 | Experimental | A single dose of MOR106 will be administered by i.v. infusion. Receives: Drug: MOR106 |
| MOR106 Single Dose B, s.c. injection, Part 1 | Experimental | A single dose of MOR106 will be administered by s.c. injection. Receives: Drug: MOR106 |
| MOR106 Single Dose C, s.c. injection, Part 1 | Experimental | A single dose of MOR106 will be administered by s.c. injection. Receives: Drug: MOR106 |
| MOR106 Single Dose D, s.c. injection, Part 1 | Experimental | A single dose of MOR106 will be administered by s.c. injection. Receives: Drug: MOR106 |
| MOR106 Repeated Doses E, s.c. injection, Part 2 | Experimental | Repeated doses of MOR106 will be administered by s.c. injection with a loading dose on the first day of administration. Receives: Drug: MOR106 |
| Placebo s.c.injection, Part 2 | Placebo comparator | Corresponding Placebo will be administered by s.c. injection. Receives: Drug: Placebo |
| MOR106 Repeated Doses F, s.c. injection, Part 3 | Experimental | Repeated doses of MOR106 will be administered by s.c. injection with a loading dose on the first day of administration. Receives: Drug: MOR106 |
| Placebo s.c.injection, Part 3 | Placebo comparator | Corresponding Placebo will be administered by s.c. injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of incidents of Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), serious adverse events (SAEs) and discontinuations due to Adverse Events (AEs) Part 1.
To evaluate the safety and tolerability of single doses of MOR106 administered s.c. in comparison to i.v.
Measured: From study drug administration until Day 50 postdose or early discontinuation (ED) visit
The number of incidents of Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), serious adverse events (SAEs) and discontinuations due to Adverse Events (AEs) Part 2.
To evaluate the safety and tolerability of multiple doses of MOR106 administered s.c.
Measured: From study drug administration until Day 197 postdose or early discontinuation (ED) visit
The number of incidents of Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), serious adverse events (SAEs) and discontinuations due to Adverse Events (AEs) Part 3.
To evaluate the safety and tolerability of multiple doses of MOR106 administered s.c.
Measured: From study drug administration until Day 155 postdose or early discontinuation (ED) visit
AUC ratio between s.c. and i.v. dosing (area under the plasma concentration-time curve) Part 1.
To determine the relative bioavailability following sc route of administration.
Measured: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit
Area under the serum concentration-time curve from time zero to infinity (AUC0-inf) Part 1.
To characterize the pharmacokinetics (PK) of MOR106.
Measured: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit
Terminal elimination half-life (t1/2) Part 1.
To characterize the PK of MOR106.
Measured: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit
Maximum observed plasma concentration (Cmax) Part 1.
To characterize the PK of MOR106.
Measured: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit
Secondary outcomes (23)
Occurrence of anti-drug antibodies (ADA) Part 1.
To monitor the occurrence of ADA after single administrations of MOR106.
Measured: From baseline through Day 50 postdose or early discontinuation (ED) visit
Occurrence of anti-drug antibodies (ADA) Part 2.
To monitor the occurrence of ADA after multiple administrations of MOR106.
Measured: From baseline through Day 197 postdose or early discontinuation (ED) visit
Occurrence of anti-drug antibodies (ADA) Part 3.
To monitor the occurrence of ADA after multiple administrations of MOR106.
Measured: From baseline through Day 155 postdose or early discontinuation (ED) visit
MOR106 serum concentrations after multiple s.c. administrations Part 2.
Steady-state will be assessed using MOR106 serum concentrations.
Measured: Between Day 1 study period and Day 197 postdose or early discontinuation (ED) visit
MOR106 serum concentrations after multiple s.c. administrations Part 3.
Steady-state will be assessed using MOR106 serum concentrations.
Measured: Between Day 1 study period and Day 155 postdose or early discontinuation (ED) visit
Percent change in Eczema Area and Severity Index (EASI) Part 2.
To assess the efficacy of MOR106 by use of EASI score. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.
Measured: From baseline to Day 85
Percent change in Eczema Area and Severity Index (EASI) Part 3.
To assess the efficacy of MOR106 by use of EASI score. 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 Part 2.
To assess the efficacy of MOR106 by use of EASI score. 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 Part 3.
To assess the efficacy of MOR106 by use of EASI score. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.
Measured: From baseline to Day 85
Time to first response of Eczema Area and Severity Index (EASI) improvement with 50% Part 2.
To assess the efficacy of MOR106 by use of EASI score. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.
Measured: From baseline to Day 85
Time to first response of Eczema Area and Severity Index (EASI) improvement with 50% Part 3.
To assess the efficacy of MOR106 by use of EASI score. 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 ≥75% and ≥90% improvement in Eczema Area and Severity Index (EASI) Part 2.
To assess the efficacy of MOR106 by use of EASI score,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 ≥75% and ≥90% improvement in Eczema Area and Severity Index (EASI) Part 3.
To assess the efficacy of MOR106 by use of EASI score,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 an Investigators' Global Assessment (IGA) score of 0 or 1 Part 2.
To assess the efficacy of MOR106 by use of IGA score, an assessment scale to determine severity of AD and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe) score. Higher values represent a worse outcome.
Measured: at Day 85 visit
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1 Part 3.
To assess the efficacy of MOR106 by use of IGA score, an assessment scale to determine severity of AD and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe) score. Higher values represent a worse outcome.
Measured: at Day 85 visit
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score reduction of ≥2 Part 2.
To assess the efficacy of MOR106 by use of IGA score, an assessment scale to determine severity of AD and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe) score. Higher values represent a worse outcome.
Measured: at Day 85 visit
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score reduction of ≥2 Part 3.
To assess the efficacy of MOR106 by use of IGA score, an assessment scale to determine severity of AD and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe) score. Higher values represent a worse outcome.
Measured: at Day 85 visit
Percent change in Scoring Atopic Dermatitis (SCORAD) score Part 2.
To assess the efficacy of MOR106 by use of SCORAD.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 Part 3.
To assess the efficacy of MOR106 by use of SCORAD.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
Absolute and percent change in body surface area (BSA), Patient Oriented Eczema Measure (POEM) score Part 2.
To assess the efficacy of MOR106 by use of POEM. The POEM is calculated by summing the score of each question resulting in a maximum score of 28 and a minimum score of 0.
Measured: From baseline to Day 85
Absolute and percent change in body surface area (BSA), Patient Oriented Eczema Measure (POEM) score Part 3.
To assess the efficacy of MOR106 by use of POEM. The POEM is calculated by summing the score of each question resulting in a maximum score of 28 and a minimum score of 0.
Measured: From baseline to Day 85
Weekly change from baseline in Pruritus Numeric Rating Scale (NRS) Part 2.
To assess the efficacy of MOR106 by NRS. An 11-point (0 - 10) scale will be used to assess itch (pruritus). 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: From screening until Day 197 or early discontinuation (ED) visit twice daily
Weekly change from baseline in Pruritus Numeric Rating Scale (NRS) Part 3.
To assess the efficacy of MOR106 by NRS. An 11-point (0 - 10) scale will be used to assess itch (pruritus). 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: From screening until Day 155 or early discontinuation (ED) visit twice daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start13 Aug 2018
- Primary completion2 Mar 2020
- Study completion2 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 HealthyStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helen Timmis, MB CHB, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689829
- Sponsor's protocol ID
- MOR106-CL-102
- Other IDs
- 2018-000357-44, 2018
- Status last verified
- Mar 2020
- First submitted
- 20 Sep 2018
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- 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 Parallel-design Phase 1 Study to Assess Safety, Tolerability and Pharmacokinetics/Exposure Following Different Single Dose Levels of MOR106 (Administered Subcutaneously or Intravenously) in Healthy Male Subjects (Randomized, Open-label), and in Subjects With Moderate to Severe Atopic Dermatitis (Randomized, Placebo-controlled, Double-blind, Repeated Subcutaneous Dosing Over 12 Weeks)
- ClinicalTrials.gov ID
- NCT03689829
- Acronym / sponsor ID
- MOR106-CL-102
- Conditions
- Healthy, Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: MOR106 clinical development in atopic dermatitis was stopped for futility
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 28 Sep 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 clinical study consists of three parts:
- Part 1 with healthy volunteers.
- Part 2 and Part 3 including subjects with moderate to severe atopic dermatitis (a skin disease).
For Part 1 the main goal of the study is to compare the safety, tolerability, and exposure of administration of the test drug via an injection in a skin layer just under the surface (subcutaneous), to administration of the test drug into the vein (intravenous).
For Part 2 and Part 3 the main goal of the study is to assess the safety and tolerability of administration of the test drug via an injection in a skin layer just under the surface (subcutaneous) during 12 weeks of treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| MOR106 Single Dose A, i.v. infusion, Part 1 | Experimental | Drug: MOR106A single dose of MOR106 will be administered by i.v. infusion. |
| MOR106 Single Dose B, s.c. injection, Part 1 | Experimental | Drug: MOR106A single dose of MOR106 will be administered by s.c. injection. |
| MOR106 Single Dose C, s.c. injection, Part 1 | Experimental | Drug: MOR106A single dose of MOR106 will be administered by s.c. injection. |
| MOR106 Single Dose D, s.c. injection, Part 1 | Experimental | Drug: MOR106A single dose of MOR106 will be administered by s.c. injection. |
| MOR106 Repeated Doses E, s.c. injection, Part 2 | Experimental | Drug: MOR106Repeated doses of MOR106 will be administered by s.c. injection with a loading dose on the first day of administration. |
| Placebo s.c.injection, Part 2 | Placebo comparator | Drug: PlaceboCorresponding Placebo will be administered by s.c. injection. |
| MOR106 Repeated Doses F, s.c. injection, Part 3 | Experimental | Drug: MOR106Repeated doses of MOR106 will be administered by s.c. injection with a loading dose on the first day of administration. |
| Placebo s.c.injection, Part 3 | Placebo comparator | Drug: PlaceboCorresponding Placebo will be administered by s.c. injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male between 18-50 years of age (extremes included), on the day of signing the informed consent form (ICF).
- Subjects between 65-88 kg (extremes included) with a body mass index (BMI) between 18-30 kg/m², inclusive.
- Judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and screening laboratory profile prior to the initial investigation medicinal product (IMP) administration.
- Male or female between 18-65 years of age (extremes included), on the day of signing ICF.
- A BMI between 18-30 kg/m², inclusive.
Key exclusion criteria (9 listed)
- Known hypersensitivity to IMP ingredients as determined by the investigator (such as, but not limited to, anaphylaxis requiring hospitalization).
- Prior treatment with MOR106.
- 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 three months prior to initial IMP 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.
- History of, or current immunosuppressive condition.
- Active chronic or acute skin infection requiring treatment with systemic (oral, sc or iv) antibiotics, antivirals or antifungals within 4 weeks of baseline, or clinical signs of infective eczema within 1 week before baseline (Day 1 pre-dose).
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 |
|---|---|---|
| MOR106The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human interleukin-17C (IL-17C). | Drug | MOR106 Repeated Doses E, s.c. injection, Part 2, MOR106 Repeated Doses F, s.c. injection, Part 3, MOR106 Single Dose A, i.v. infusion, Part 1, MOR106 Single Dose B, s.c. injection, Part 1, MOR106 Single Dose C, s.c. injection, Part 1, MOR106 Single Dose D, s.c. injection, Part 1 |
| PlaceboCorresponding placebo s.c. injections. | Drug | Placebo s.c.injection, Part 2, Placebo s.c.injection, Part 3 |
Primary outcome
The number of incidents of Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), serious adverse events (SAEs) and discontinuations due to Adverse Events (AEs) Part 1.
Time frame: From study drug administration until Day 50 postdose or early discontinuation (ED) visit
To evaluate the safety and tolerability of single doses of MOR106 administered s.c. in comparison to i.v.
The number of incidents of Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), serious adverse events (SAEs) and discontinuations due to Adverse Events (AEs) Part 2.
Time frame: From study drug administration until Day 197 postdose or early discontinuation (ED) visit
To evaluate the safety and tolerability of multiple doses of MOR106 administered s.c.
The number of incidents of Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), serious adverse events (SAEs) and discontinuations due to Adverse Events (AEs) Part 3.
Time frame: From study drug administration until Day 155 postdose or early discontinuation (ED) visit
To evaluate the safety and tolerability of multiple doses of MOR106 administered s.c.
AUC ratio between s.c. and i.v. dosing (area under the plasma concentration-time curve) Part 1.
Time frame: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit
To determine the relative bioavailability following sc route of administration.
Area under the serum concentration-time curve from time zero to infinity (AUC0-inf) Part 1.
Time frame: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit
To characterize the pharmacokinetics (PK) of MOR106.
Terminal elimination half-life (t1/2) Part 1.
Time frame: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit
To characterize the PK of MOR106.
Maximum observed plasma concentration (Cmax) Part 1.
Time frame: Between Day 1 study period and Day 50 postdose or early discontinuation (ED) visit
To characterize the PK of MOR106.
23 secondary outcomes
Occurrence of anti-drug antibodies (ADA) Part 1.
Time frame: From baseline through Day 50 postdose or early discontinuation (ED) visit
Occurrence of anti-drug antibodies (ADA) Part 2.
Time frame: From baseline through Day 197 postdose or early discontinuation (ED) visit
Occurrence of anti-drug antibodies (ADA) Part 3.
Time frame: From baseline through Day 155 postdose or early discontinuation (ED) visit
MOR106 serum concentrations after multiple s.c. administrations Part 2.
Time frame: Between Day 1 study period and Day 197 postdose or early discontinuation (ED) visit
MOR106 serum concentrations after multiple s.c. administrations Part 3.
Time frame: Between Day 1 study period and Day 155 postdose or early discontinuation (ED) visit
Percent change in Eczema Area and Severity Index (EASI) Part 2.
Time frame: From baseline to Day 85
Percent change in Eczema Area and Severity Index (EASI) Part 3.
Time frame: From baseline to Day 85
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score Part 2.
Time frame: From baseline to Day 85
Proportion of subjects who achieve ≥50% overall improvement in Eczema Area and Severity Index (EASI) score Part 3.
Time frame: From baseline to Day 85
Time to first response of Eczema Area and Severity Index (EASI) improvement with 50% Part 2.
Time frame: From baseline to Day 85
Time to first response of Eczema Area and Severity Index (EASI) improvement with 50% Part 3.
Time frame: From baseline to Day 85
Proportion of subjects who achieve ≥75% and ≥90% improvement in Eczema Area and Severity Index (EASI) Part 2.
Time frame: From baseline to Day 85
Proportion of subjects who achieve ≥75% and ≥90% improvement in Eczema Area and Severity Index (EASI) Part 3.
Time frame: From baseline to Day 85
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1 Part 2.
Time frame: at Day 85 visit
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score of 0 or 1 Part 3.
Time frame: at Day 85 visit
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score reduction of ≥2 Part 2.
Time frame: at Day 85 visit
Proportion of subjects who achieve an Investigators' Global Assessment (IGA) score reduction of ≥2 Part 3.
Time frame: at Day 85 visit
Percent change in Scoring Atopic Dermatitis (SCORAD) score Part 2.
Time frame: From baseline to Day 85
Percent change in Scoring Atopic Dermatitis (SCORAD) score Part 3.
Time frame: From baseline to Day 85
Absolute and percent change in body surface area (BSA), Patient Oriented Eczema Measure (POEM) score Part 2.
Time frame: From baseline to Day 85
Absolute and percent change in body surface area (BSA), Patient Oriented Eczema Measure (POEM) score Part 3.
Time frame: From baseline to Day 85
Weekly change from baseline in Pruritus Numeric Rating Scale (NRS) Part 2.
Time frame: From screening until Day 197 or early discontinuation (ED) visit twice daily
Weekly change from baseline in Pruritus Numeric Rating Scale (NRS) Part 3.
Time frame: From screening until Day 155 or early discontinuation (ED) visit twice daily
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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Healthy Volunteers
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, MB CHB study director
Lakefront Biotherapeutics NV
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MOR106 in people with Healthy and Atopic Dermatitis, run by Lakefront Biotherapeutics NV at 15 sites in 4 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 13 inclusion and 9 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 15 sites in Germany, Spain, United Kingdom, Ukraine. 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 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.
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?
The number of incidents of Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), serious adverse events (SAEs) and discontinuations due to Adverse Events (AEs) Part 1. (time frame: From study drug administration until Day 50 postdose or early discontinuation (ED) visit). The study lists 7 primary outcomes in all. 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.