Company Update - MorphoSys

CNTO1959: HuCAL Antibody for the
Treatment of Patients with Psoriasis
A Study to Evaluate CNTO 1959 in the Treatment of Patients
With Moderate to Severe Plaque-type Psoriasis (X-PLORE)
Status Phase 2 (recruiting)
Study Design
Study Start Date October 2011
Completion Date February 2014
Enrollment 280
Primary
Outcome
Measures
Secondary
Outcome
Measures
Treatment
Randomized, double-blind, placebo-controlled
study
Physician's Global Assessment (PGA) score of
cleared or minimal (Time Frame: Week 16);
Overall assessment of induration, scaling, and
erythema
� Psoriasis Area and Severity Index (PASI) 75%
or greater improvement from baseline
(Time Frame: Week 16)
� The difference in the PGA score of cleared (0)
or minimal (1) response rate between CNTO
1959 treatment groups and adalimumab treatment
group (Time Frame: Weeks 16 and 40)
� The change from baseline in Dermatology Life
Quality Index (DLQI) (Time Frame: Week 16)
� 5 groups: CNTO 1959 (5 mg / 15 mg / 50 mg /
100 mg / 200 mg
� Drug: Adalimumab
� Drug: Placebo to CNTO 1959 (100 mg)
A Study of the Safety, Tolerability, Pharmacokinetics, and
Pharmacodynamics of CNTO 1959 Following a Single SC
Administration in Japanese Participants With Moderate to
Severe Plaque Psoriasis
Status Phase 1 (recruiting)
Study Design
Study Start Date August 2011
Completion Date June 2013
Enrollment 32
Primary
Outcome
Measures
Secondary
Outcome
Measures
Treatment
Randomized, double-blind, placebo-controlled
study
� The number and type of adverse events
� Change in clinical laboratory values
� Electrocardiogram
� Changes or abnormalities in body systems
� Axillary temperature
� Pulse rate
� Blood pressure (Time Frame: Up to 24 weeks)
� Blood levels of CNTO 1959
� Antibodies to CNTO 1959
� Psoriasis Area and Severity Index (PASI)
Physician's Global Assessment (PGA)
� Drug: CNTO 1959 (10mg, 30mg, 100mg,
300mg, subcutaneous use, ascending dosing
for 24 weeks
� Drug: Placebo
© MorphoSys AG
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