Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:10/19/2018
Start Date:September 2015
End Date:April 4, 2017

Use our guide to learn which trials are right for you!

A Phase 3 Randomized, Double-blind, Multicenter Study to Evaluate Efficacy, Safety, and Immunogenicity of an Adalimumab Biosimilar (M923) and Humira® in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

The purpose of the study is to evaluate efficacy, safety, and immunogenicity of a proposed
adalimumab biosimilar (M923) and Humira in participants with moderate to severe chronic
plaque-type psoriasis.


Inclusion Criteria:

1. Must be able to understand and communicate with the investigator and comply with the
requirements of the study

2. Chronic plaque-type psoriasis diagnosed for at least 6 months before screening

3. Stable plaque psoriasis

4. History of receipt of or candidate for therapy.

5. Moderate to severe psoriasis at screening and baseline

6. Must be willing and able to self-administer SC injections or have a caregiver
available to administer injections

7. Male participants of childbearing potential must employ a highly effective
contraceptive measure

8. Female participants must have a negative pregnancy test; are not planning to become
pregnant; and must not be lactating. Female participants must also agree to employ a
highly effective contraceptive measure.

Exclusion Criteria:

1. Forms of psoriasis other than chronic plaque-type

2. Drug-induced psoriasis.

3. Other skin conditions which would interfere with assessment of psoriasis

4. Medical conditions other than psoriasis for which systemic corticosteroids were used
in the last year prior to screening

5. Other inflammatory conditions other than psoriasis or psoriatic arthritis

6. Prior use of systemic tumor necrosis factor (TNF) inhibitors, or 2 or more non-TNF
biologic therapies

7. Ongoing use of prohibited psoriasis treatments

8. Ongoing use of other non-psoriasis prohibited treatments

9. All other prior non-psoriasis concomitant treatments must be on a stable dose for at
least 4 weeks

10. Laboratory abnormalities at screening deemed clinically significant by the
investigator

11. Any condition or illness which in the opinion of the investigator or sponsor poses an
unacceptable safety risk

12. History of latex allergy

13. History of or current signs or symptoms or diagnosis of a demyelinating disorder

14. History of or current Class III or IV New York Heart Association congestive heart
failure

15. Signs, symptoms, or diagnosis of lymphoproliferative disorders, lymphoma, leukemia,
myeloproliferative disorders, or multiple myeloma

16. Current malignancy or history of any malignancy except adequately treated or excised
non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in
situ; no more than 3 lifetime basal cell and squamous cell carcinomas permitted

17. Chronic infections, recurrent infections; recent infection to be evaluated

18. History of or presence of human immunodeficiency virus (HIV), or Hepatitis B (HBV) or
C virus (HCV)

19. History of active tuberculosis (TB) or untreated or inadequately treated latent TB.

20. Exposure to an investigational product ≤30 days prior to enrollment or participation
in another clinical study during the course of this study

21. Participant is a family member or employee of the investigator or site staff or study
team
We found this trial at
25
sites
?
mi
from
Richmond, VA
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
?
mi
from
Denver, CO
Click here to add this to my saved trials
104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
?
mi
from
Ocala, FL
Click here to add this to my saved trials
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Anderson, South Carolina 29621
?
mi
from
Anderson, SC
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Cincinnati, Ohio 45249
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Columbus, Ohio 43212
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dupnitsa,
Click here to add this to my saved trials
Encino, California 91436
?
mi
from
Encino, CA
Click here to add this to my saved trials
Fountain Inn, South Carolina 29644
?
mi
from
Fountain Inn, SC
Click here to add this to my saved trials
Greer, South Carolina
?
mi
from
Greer, SC
Click here to add this to my saved trials
Indianapolis, Indiana 46256
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
La Mesa, California 91942
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89109
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Miami, Florida 33155
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33155
?
mi
from
Miami, FL
Click here to add this to my saved trials
Oceanside, California 92056
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
Overland Park, Kansas 66202
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
?
mi
from
Pflugerville, TX
Click here to add this to my saved trials
San Diego, California 92120
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Sherman Oaks, California 91403
?
mi
from
Sherman Oaks, CA
Click here to add this to my saved trials
Watertown, Massachusetts 02472
?
mi
from
Watertown, MA
Click here to add this to my saved trials