search
Back to results

First in Human of Single and Multiple Doses of MOR106

Primary Purpose

Healthy, Dermatitis, Atopic

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MOR106 single ascending doses, intravenous
Placebo single ascending doses, intravenous
MOR106 multiple ascending doses, intravenous
Placebo multiple intravenous administrations
Sponsored by
Galapagos NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- 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

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

Exclusion Criteria:

  • 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.

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

Sites / Locations

  • SGS LSS Clinical Pharmacology Unit
  • St Johns Hospital
  • • Arensia Phase I unit
  • Arensia Phase I unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

MOR106

Placebo

MOR106 MAD

Placebo MAD

Arm Description

Single intravenous administration of MOR106

Single intravenous administration of Placebo

Multiple intravenous administration of MOR106

Multiple intravenous adminstration of Placebo

Outcomes

Primary Outcome Measures

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
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
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
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
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
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

Secondary Outcome Measures

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
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
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
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
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
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

Full Information

First Posted
April 1, 2016
Last Updated
October 4, 2017
Sponsor
Galapagos NV
Collaborators
MorphoSys AG
search

1. Study Identification

Unique Protocol Identification Number
NCT02739009
Brief Title
First in Human of Single and Multiple Doses of MOR106
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galapagos NV
Collaborators
MorphoSys AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Dermatitis, Atopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MOR106
Arm Type
Experimental
Arm Description
Single intravenous administration of MOR106
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single intravenous administration of Placebo
Arm Title
MOR106 MAD
Arm Type
Experimental
Arm Description
Multiple intravenous administration of MOR106
Arm Title
Placebo MAD
Arm Type
Placebo Comparator
Arm Description
Multiple intravenous adminstration of Placebo
Intervention Type
Drug
Intervention Name(s)
MOR106 single ascending doses, intravenous
Intervention Type
Drug
Intervention Name(s)
Placebo single ascending doses, intravenous
Intervention Type
Drug
Intervention Name(s)
MOR106 multiple ascending doses, intravenous
Intervention Type
Drug
Intervention Name(s)
Placebo multiple intravenous administrations
Primary Outcome Measure Information:
Title
Difference as compared to placebo in the number of subjects with treatment-emergent adverse events
Description
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
Time Frame
Up to 99 days after dosing
Title
Difference as compared to placebo in the number of subjects with deviating physical examination results
Description
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
Time Frame
Up to 99 days after dosing
Title
Difference as compared to placebo in the number of subjects with abnormal vital signs
Description
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
Time Frame
Up to 99 days after dosing
Title
Difference as compared to placebo in the number of subjects with abnormal 12-lead ECG results
Description
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
Time Frame
Up to 99 days after dosing
Title
Difference as compared to placebo in the number of subjects with abnormal laboratory findings
Description
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
Time Frame
Up to 99 days after dosing
Title
Difference as compared to placebo in the occurrence of infusion related reactions
Description
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
Time Frame
Up to 99 days after dosing
Secondary Outcome Measure Information:
Title
Serum concentration (Cinf) of MOR106
Description
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
Time Frame
up to 99 days after dosing
Title
Area under the curve (AUC) of MOR106
Description
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
Time Frame
up to 99 days after dosing
Title
terminal elimination half-life (t1/2) of MOR106
Description
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
Time Frame
up to 99 days after dosing
Title
total serum clearance (CL) of MOR106
Description
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
Time Frame
up to 99 days after dosing
Title
volume of distribution at steady state (Vss) of MOR106
Description
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
Time Frame
up to 99 days after dosing
Title
The presence of anti-drug antibodies in serum over time after single intravenous dose
Description
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
Time Frame
up to 9 days after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - 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 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 Exclusion Criteria: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Timmis, MBChB
Organizational Affiliation
Galapagos NV
Official's Role
Study Director
Facility Information:
Facility Name
SGS LSS Clinical Pharmacology Unit
City
Antwerp
Country
Belgium
Facility Name
St Johns Hospital
City
Budapest
Country
Hungary
Facility Name
• Arensia Phase I unit
City
Chisinau
Country
Moldova, Republic of
Facility Name
Arensia Phase I unit
City
Bucharest
Country
Romania

12. IPD Sharing Statement

Learn more about this trial

First in Human of Single and Multiple Doses of MOR106

We'll reach out to this number within 24 hrs