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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

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.

Condition or disease Intervention/treatment Phase
Healthy Dermatitis, Atopic Drug: MOR106 single ascending doses, intravenous Drug: Placebo single ascending doses, intravenous Drug: MOR106 multiple ascending doses, intravenous Drug: Placebo multiple intravenous administrations Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2016
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : August 1, 2017

Arm Intervention/treatment
Experimental: MOR106
Single intravenous administration of MOR106
Drug: MOR106 single ascending doses, intravenous
Placebo Comparator: Placebo
Single intravenous administration of Placebo
Drug: Placebo single ascending doses, intravenous
Experimental: MOR106 MAD
Multiple intravenous administration of MOR106
Drug: MOR106 multiple ascending doses, intravenous
Placebo Comparator: Placebo MAD
Multiple intravenous adminstration of Placebo
Drug: Placebo multiple intravenous administrations



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739009


Locations
Belgium
SGS LSS Clinical Pharmacology Unit
Antwerp, Belgium
Hungary
St Johns Hospital
Budapest, Hungary
Moldova, Republic of
• Arensia Phase I unit
Chisinau, Moldova, Republic of
Romania
Arensia Phase I unit
Bucharest, Romania
Sponsors and Collaborators
Galapagos NV
MorphoSys AG
Investigators
Study Director: Helen Timmis, MBChB Galapagos NV

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT02739009     History of Changes
Other Study ID Numbers: MOR106-CL-101
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases