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First in Human of Single and Multiple Doses of MOR106

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ClinicalTrials.gov Identifier: NCT02739009
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
MorphoSys AG
Information provided by (Responsible Party):
Galapagos NV

Tracking Information
First Submitted Date  ICMJE April 1, 2016
First Posted Date  ICMJE April 14, 2016
Last Update Posted Date October 5, 2017
Study Start Date  ICMJE April 2016
Actual Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
  • Difference as compared to placebo in the number of subjects with treatment-emergent adverse events [ Time Frame: Up to 50 days after dosing ]
    To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects, compared to placebo
  • Difference as compared to placebo in the number of subjects with deviating physical examination results [ Time Frame: Up to 50 days after dosing ]
    To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects, compared to placebo
  • Difference as compared to placebo in the number of subjects with abnormal vital signs [ Time Frame: Up to 50 days after dosing ]
    To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects, compared to placebo
  • Difference as compared to placebo in the number of subjects with abnormal 12-lead ECG results [ Time Frame: Up to 50 days after dosing ]
    To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects, compared to placebo
  • Difference as compared to placebo in the number of subjects with abnormal laboratory findings [ Time Frame: Up to 50 days after dosing ]
    To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects, compared to placebo
  • Difference as compared to placebo in the occurrence of infusion related reactions [ Time Frame: Up to 50 days after dosing ]
    To evaluate the safety and tolerability of single ascending doses of MOR106
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
  • Serum concentration (Cinf) of MOR106 [ Time Frame: up to 99 days after dosing ]
    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 [ Time Frame: up to 99 days after dosing ]
    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 [ Time Frame: up to 99 days after dosing ]
    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 [ Time Frame: up to 99 days after dosing ]
    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 [ Time Frame: up to 99 days after dosing ]
    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 [ Time Frame: up to 9 days after dosing ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
  • Serum concentration (Cinf) of MOR106 [ Time Frame: up to 50 days after dosing ]
    To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers
  • Area under the curve (AUC) of MOR106 [ Time Frame: up to 50 days after dosing ]
    To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers
  • terminal elimination half-life (t1/2) of MOR106 [ Time Frame: up to 50 days after dosing ]
    To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers
  • total serum clearance (CL) of MOR106 [ Time Frame: up to 50 days after dosing ]
    To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers
  • volume of distribution at steady state (Vss) of MOR106 [ Time Frame: up to 50 days after dosing ]
    To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers
  • The presence of anti-drug antibodies in serum over time after single intravenous dose [ Time Frame: up to 50 days after dosing ]
    To assess the presence of anti-drug antibodies as a measure of immunogenicity after single administration of MOR106
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First in Human of Single and Multiple Doses of MOR106
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy
  • Dermatitis, Atopic
Intervention  ICMJE
  • Drug: MOR106 single ascending doses, intravenous
  • Drug: Placebo single ascending doses, intravenous
  • Drug: MOR106 multiple ascending doses, intravenous
  • Drug: Placebo multiple intravenous administrations
Study Arms  ICMJE
  • Experimental: MOR106
    Single intravenous administration of MOR106
    Intervention: Drug: MOR106 single ascending doses, intravenous
  • Placebo Comparator: Placebo
    Single intravenous administration of Placebo
    Intervention: Drug: Placebo single ascending doses, intravenous
  • Experimental: MOR106 MAD
    Multiple intravenous administration of MOR106
    Intervention: Drug: MOR106 multiple ascending doses, intravenous
  • Placebo Comparator: Placebo MAD
    Multiple intravenous adminstration of Placebo
    Intervention: Drug: Placebo multiple intravenous administrations
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2017)
81
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2016)
56
Actual Study Completion Date  ICMJE August 1, 2017
Actual Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Hungary,   Moldova, Republic of,   Romania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02739009
Other Study ID Numbers  ICMJE MOR106-CL-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galapagos NV
Study Sponsor  ICMJE Galapagos NV
Collaborators  ICMJE MorphoSys AG
Investigators  ICMJE
Study Director: Helen Timmis, MBChB Galapagos NV
PRS Account Galapagos NV
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP