HealthyPhase 1NCT02739009
First in Human of Single and Multiple Doses of MOR106
A Phase 1 study testing MOR106 single ascending doses, intravenous and MOR106 multiple ascending doses, intravenous in people with Healthy and Dermatitis, Atopic, run by Lakefront Biotherapeutics NV at 4 sites in 4 countries.
Trial summary
This is a randomized, double-blind, placebo-controlled, dose-escalation, phase I study for the assessment of safety, tolerability and pharmacokinetics of single ascending doses of MOR106 in healthy male subjects and multiple ascending doses in subjects with moderate to severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Dermatitis, Atopic
- What is being tested?
- MOR106 single ascending doses, intravenous and MOR106 multiple ascending doses, intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Apr 2016to 1 Aug 2017
- 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
- Able and willing to give voluntary written informed consent
- Single ascending dose (SAD)
- Negative urine drug screen
- Male between 18-50 years of age
- A body mass index (BMI) between 18-30 kg/m², inclusive.
- Judged to be in good health
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- Multiple ascending dose (MAD)
- Male or female between 18-65 years of age
- A BMI between 18-30 kg/m²
- Diagnosis of Atopic Dermatitis (AD) for at least 6 months as per the Hanifin and Rajka Criteria
- EASI ≥ 16 at the screening and baseline visits
- IGA score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at the screening and baseline visits
- Greater than or equal to 10% body surface area (BSA) of AD involvement at screening
- Willingness to continue stable use of an additive free, basic, bland emollient twice daily for at least 7 days before the baseline visit
- Subject is a candidate for systemic therapy and is not responding adequately or has a contraindication to topical corticosteroids and/or topical calcineurin inhibitors (per Investigator's judgement)
- Absence of current active, latent or history of tuberculosis (TB) infection based on medical history and as determined by a negative QuantiFERON TB Gold test at screening
- Female subjects 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 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
Who cannot join
- Known hypersensitivity to study drug ingredients.
- History of or a current immunosuppressive condition
- Symptoms of clinically significant illness in the 3 months before the initial study drug administration.
- Any concurrent illness, condition, disability, or clinically significant abnormality
- Treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months preceding the initial study drug administration.
- A history of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal (GI), pulmonary, or metabolic disease.
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- MAD only
- Active (skin) infection requiring systemic antibiotics
- immunosuppressive/immunomodulating drugs or phototherapy 4 weeks prior to baseline
- Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline
- Treatment with biologics within 5 half-lives (if known) or 12 weeks prior to baseline visit
- history of immunosuppression
- Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit
- Regular daily use of oral nonsteroidal anti-inflammatory drugs (NSAIDs), except low-dose aspirin (≤200 mg/day) for cardioprotection, within 7 days prior to screening
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
This is a randomized, double-blind, placebo-controlled, dose-escalation, phase I study for the assessment of safety, tolerability and pharmacokinetics of single ascending doses of MOR106 in healthy male subjects and multiple ascending doses in subjects with moderate to severe atopic dermatitis.
- Conditions
- Healthy, Dermatitis, Atopic
- Being tested
- MOR106 single ascending doses, intravenous, Placebo single ascending doses, intravenous, MOR106 multiple ascending doses, intravenous, Placebo multiple intravenous administrations
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOR106 single ascending doses, intravenousDrug
Placebo single ascending doses, intravenousDrug
MOR106 multiple ascending doses, intravenousDrug
Placebo multiple intravenous administrationsDrug
| Study group | Role | What they receive |
|---|---|---|
| MOR106 | Experimental | Single intravenous administration of MOR106 Receives: Drug: MOR106 single ascending doses, intravenous |
| Placebo | Placebo comparator | Single intravenous administration of Placebo Receives: Drug: Placebo single ascending doses, intravenous |
| MOR106 MAD | Experimental | Multiple intravenous administration of MOR106 Receives: Drug: MOR106 multiple ascending doses, intravenous |
| Placebo MAD | Placebo comparator | Multiple intravenous adminstration of Placebo Receives: Drug: Placebo multiple intravenous administrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference as compared to placebo in the number of subjects with treatment-emergent adverse events
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Measured: Up to 99 days after dosing
Difference as compared to placebo in the number of subjects with deviating physical examination results
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Measured: Up to 99 days after dosing
Difference as compared to placebo in the number of subjects with abnormal vital signs
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Measured: Up to 99 days after dosing
Difference as compared to placebo in the number of subjects with abnormal 12-lead ECG results
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Measured: Up to 99 days after dosing
Difference as compared to placebo in the number of subjects with abnormal laboratory findings
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Measured: Up to 99 days after dosing
Difference as compared to placebo in the occurrence of infusion related reactions
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Measured: Up to 99 days after dosing
Secondary outcomes (6)
Serum concentration (Cinf) of MOR106
To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis
Measured: up to 99 days after dosing
Area under the curve (AUC) of MOR106
To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis
Measured: up to 99 days after dosing
terminal elimination half-life (t1/2) of MOR106
To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis
Measured: up to 99 days after dosing
total serum clearance (CL) of MOR106
To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis
Measured: up to 99 days after dosing
volume of distribution at steady state (Vss) of MOR106
To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis
Measured: up to 99 days after dosing
The presence of anti-drug antibodies in serum over time after single intravenous dose
To assess the presence of anti-drug antibodies as a measure of immunogenicity after single administration of MOR106 and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis
Measured: up to 9 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MorphoSys AG
- Responsible party
- Sponsor
- Investigators
- Helen Timmis, MBChB, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739009
- Sponsor's protocol ID
- MOR106-CL-101
- Status last verified
- Oct 2017
- First submitted
- 1 Apr 2016
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human of Single and Multiple Doses of MOR106
- ClinicalTrials.gov ID
- NCT02739009
- Acronym / sponsor ID
- MOR106-CL-101
- Conditions
- Healthy, Dermatitis, Atopic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Collaborators
- MorphoSys AG
- Study start
- Apr 2016
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, dose-escalation, phase I study for the assessment of safety, tolerability and pharmacokinetics of single ascending doses of MOR106 in healthy male subjects and multiple ascending doses in subjects with moderate to severe atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MOR106 | Experimental | Drug: MOR106 single ascending doses, intravenousSingle intravenous administration of MOR106 |
| Placebo | Placebo comparator | Drug: Placebo single ascending doses, intravenousSingle intravenous administration of Placebo |
| MOR106 MAD | Experimental | Drug: MOR106 multiple ascending doses, intravenousMultiple intravenous administration of MOR106 |
| Placebo MAD | Placebo comparator | Drug: Placebo multiple intravenous administrationsMultiple intravenous adminstration of Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Able and willing to give voluntary written informed consent
- Single ascending dose (SAD)
- Negative urine drug screen
- Male between 18-50 years of age
- A body mass index (BMI) between 18-30 kg/m², inclusive.
Key exclusion criteria (14 listed)
- Known hypersensitivity to study drug ingredients.
- History of or a current immunosuppressive condition
- Symptoms of clinically significant illness in the 3 months before the initial study drug administration.
- Any concurrent illness, condition, disability, or clinically significant abnormality
- Treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months preceding the initial study drug administration.
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 |
|---|---|---|
| MOR106 single ascending doses, intravenous | Drug | MOR106 |
| Placebo single ascending doses, intravenous | Drug | Placebo |
| MOR106 multiple ascending doses, intravenous | Drug | MOR106 MAD |
| Placebo multiple intravenous administrations | Drug | Placebo MAD |
Primary outcome
Difference as compared to placebo in the number of subjects with treatment-emergent adverse events
Time frame: Up to 99 days after dosing
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Difference as compared to placebo in the number of subjects with deviating physical examination results
Time frame: Up to 99 days after dosing
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Difference as compared to placebo in the number of subjects with abnormal vital signs
Time frame: Up to 99 days after dosing
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Difference as compared to placebo in the number of subjects with abnormal 12-lead ECG results
Time frame: Up to 99 days after dosing
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Difference as compared to placebo in the number of subjects with abnormal laboratory findings
Time frame: Up to 99 days after dosing
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Difference as compared to placebo in the occurrence of infusion related reactions
Time frame: Up to 99 days after dosing
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
6 secondary outcomes
Serum concentration (Cinf) of MOR106
Time frame: up to 99 days after dosing
Area under the curve (AUC) of MOR106
Time frame: up to 99 days after dosing
terminal elimination half-life (t1/2) of MOR106
Time frame: up to 99 days after dosing
total serum clearance (CL) of MOR106
Time frame: up to 99 days after dosing
volume of distribution at steady state (Vss) of MOR106
Time frame: up to 99 days after dosing
The presence of anti-drug antibodies in serum over time after single intravenous dose
Time frame: up to 9 days after dosing
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 5 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Timmis, MBChB study director
Lakefront Biotherapeutics NV
4 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 single ascending doses, intravenous and MOR106 multiple ascending doses, intravenous in people with Healthy and Dermatitis, Atopic, run by Lakefront Biotherapeutics NV at 4 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 18 inclusion and 14 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 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Hungary, Moldova, Romania. 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 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?
Difference as compared to placebo in the number of subjects with treatment-emergent adverse events (time frame: Up to 99 days after dosing). The study lists 6 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 5 Oct 2017.