MedPath

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

Phase 3
Completed
Conditions
Chronic Plaque Psoriasis
Psoriasis
Interventions
Biological: M923
Biological: Humira
Registration Number
NCT02581345
Lead Sponsor
Momenta Pharmaceuticals, Inc.
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
572
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
M923 and HumiraM923Participants assigned to receive M923 and Humira
M923M923Participants assigned to receive M923
HumiraHumiraParticipants assigned to receive Humira
M923 and HumiraHumiraParticipants assigned to receive M923 and Humira
Primary Outcome Measures
NameTimeMethod
Percentage of Participants Who Achieved a 75% Reduction in Psoriasis Area and Severity Index (PASI) (PASI 75) Scores at Week 16Baseline; Week 16

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 75 are defined as having an improvement (reduction) of at least 75% in the Week 16 PASI score compared to the score at Baseline.

Secondary Outcome Measures
NameTimeMethod
Percentage of Participants With a Response of Clear or Almost Clear on the Static Physician Global Assessment (sPGA) at Week 16Week 16

The sPGA response rate was defined as the percentage of participants who had achieved a clear or almost clear response on the 6-point sPGA scale. The sPGA was the physician's determination of the participant's psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis was assessed at a given time point on a 6-point scale on which 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe.

Number of Participants Achieving PASI 50 Response at Week 16Baseline; Week 16

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 50 are defined as having an improvement (reduction) of at least 50% compared to Baseline.

Number of Participants Achieving PASI 50 Response at Week 52 (Follow-Up Visit)Baseline; Week 52

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 50 are defined as having an improvement (reduction) of at least 50% compared to Baseline.

Number of Participants Achieving PASI 75 Response at Week 52 (Follow-Up Visit)Baseline; Week 52

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 75 are defined as having an improvement (reduction) of at least 75% compared to Baseline.

Number of Participants Achieving PASI 90 Response at Week 16Baseline; Week 16

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 90 are defined as having an improvement (reduction) of at least 90% compared to Baseline.

Number of Participants Achieving PASI 90 Response at Week 52 (Follow-Up Visit)Baseline; Week 52

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 90 are defined as having an improvement (reduction) of at least 90% compared to Baseline.

Absolute PASI Score at BaselineBaseline

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score.

Absolute PASI Score at Week 16Week 16

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score.

Absolute PASI Score at Week 52 (Follow-Up Visit)Week 52

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score.

Percent Change From Baseline in PASI Score at Week 16Baseline; Week 16

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Percent change from Baseline was calculated as: (post-Baseline value - Baseline value) / (Baseline value) \* 100.

Percent Change From Baseline in PASI Score at Week 52 (Follow-Up Visit)Baseline; Week 52

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Percent change from Baseline was calculated as: (post-Baseline value - Baseline value) / (Baseline value) \* 100.

Health-Related Quality of Life During Treatment: Dermatology Life Quality Index (DLQI) Score at BaselineBaseline

The DLQI score was calculated by summing the individual scores of each question at a given time point, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. For the analysis of responses, the participant's results were assessed on a scoring scale on which 3 = very much or yes (applicable to question 7 only), 2 = a lot, 1 = a little, 0 = not at all or not relevant. Interpretation of DLQI scoring can be taken as 0 - 1 = no effect at all on participant's life, 2 - 5 = small effect on participant's life, 6 - 10 = moderate effect on participant's life, 11 - 20 = very large effect on participant's life, and 21 - 30 = extremely large effect on participant's life.

Health-Related Quality of Life During Treatment: DLQI Score at Week 16Week 16

The DLQI score was calculated by summing the individual scores of each question at a given time point, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. For the analysis of responses, the participant's results were assessed on a scoring scale on which 3 = very much or yes (applicable to question 7 only), 2 = a lot, 1 = a little, 0 = not at all or not relevant. Interpretation of DLQI scoring can be taken as 0 - 1 = no effect at all on participant's life, 2 - 5 = small effect on participant's life, 6 - 10 = moderate effect on participant's life, 11 - 20 = very large effect on participant's life, and 21 - 30 = extremely large effect on participant's life.

Health-Related Quality of Life During Treatment: DLQI Score at Week 48 (Completion/Termination Visit)Week 48

The DLQI score was calculated by summing the individual scores of each question at a given time point, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. For the analysis of responses, the participant's results were assessed on a scoring scale on which 3 = very much or yes (applicable to question 7 only), 2 = a lot, 1 = a little, 0 = not at all or not relevant. Interpretation of DLQI scoring can be taken as 0 - 1 = no effect at all on participant's life, 2 - 5 = small effect on participant's life, 6 - 10 = moderate effect on participant's life, 11 - 20 = very large effect on participant's life, and 21 - 30 = extremely large effect on participant's life.

Health-Related Quality of Life During Treatment: EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D-5L) at BaselineBaseline

The EQ-5D-5L health score was measured on a Visual Analog Scale (VAS) anchored by 0 = "worst health you can imagine" and 100 = "best health you can imagine". Baseline was defined as the last scheduled observation prior to dosing, typically Day 1, predose.

Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 16Week 16

The EQ-5D-5L health score was measured on a Visual Analog Scale (VAS) anchored by 0 = "worst health you can imagine" and 100 = "best health you can imagine".

Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 48 (Completion/Termination Visit)Week 48

The EQ-5D-5L health score was measured on a Visual Analog Scale (VAS) anchored by 0 = "worst health you can imagine" and 100 = "best health you can imagine".

Number of Participants With Clinically Meaningful Changes in Vital SignsUp to Week 52

Vital signs included body temperature, respiratory rate, pulse rate, systolic and diastolic blood pressure, and weight. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.

Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at BaselineBaseline

Laboratory results included hematology \[Hemoglobin, Hematocrit, Platelet count, Mean cell volume, White blood cell count (total leucocytes), Neutrophils absolute, Neutrophils, Lymphocytes absolute, Lymphocytes, Monocytes, Eosinophils absolute, and Eosinophils\], chemistry (Aspartate transaminase, Alanine transaminase, Gamma glutamyl transferase, Creatine kinase, C-reactive protein, Cholesterol, Triglycerides, Total protein, Potassium, Urea, Creatinine, Phosphate, Glucose, and Uric acid) and urinalysis \[Specific Gravity\] parameters. Laboratory results of a few hematology (Red Blood Cell Count and Monocytes absolute), chemistry (Alkaline Phosphatase, Total bilirubin, Sodium, Chloride, and Albumin), and urinalysis (pH) parameters were not assessed at Baseline and Week 16. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.

Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16Week 16

Laboratory results included hematology \[Hemoglobin, Hematocrit, Platelet count, Mean cell volume, White blood cell count (total leucocytes), Neutrophils absolute, Neutrophils, Lymphocytes absolute, Lymphocytes, Monocytes, Eosinophils absolute, and Eosinophils\], chemistry (Aspartate transaminase, Alanine transaminase, Gamma glutamyl transferase, Creatine kinase, C-reactive protein, Cholesterol, Triglycerides, Total protein, Potassium, Urea, Creatinine, Phosphate, Glucose, and Uric acid) and urinalysis \[Specific Gravity\] parameters. Laboratory results of a few hematology (Red Blood Cell Count and Monocytes absolute), chemistry (Alkaline Phosphatase, Total bilirubin, Sodium, Chloride, and Albumin), and urinalysis (pH) parameters were not assessed at Baseline and Week 16. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.

Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit)Week 48

Laboratory results included hematology \[Red Blood Cell Count, Hemoglobin, Hematocrit, Platelet count, Mean cell volume, White blood cell count (total leucocytes), Neutrophils absolute, Neutrophils, Lymphocytes absolute, Lymphocytes, Monocytes absolute, Monocytes, Eosinophils absolute, and Eosinophils\], chemistry (Aspartate transaminase, Alanine transaminase, Alkaline Phosphatase, Gamma glutamyl transferase, Total bilirubin, Creatine kinase, C-reactive protein, Cholesterol, Triglycerides, Total protein, Sodium, Potassium, Chloride, Urea, Creatinine, Albumin, Phosphate, Glucose, and Uric acid) and urinalysis \[pH and Specific Gravity\] parameters. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.

Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at BaselineBaseline

Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.

Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 16Week 16

Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.

Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 48 (Completion/Termination Visit)Week 48

Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.

Number of Participants With Treatment-emergent Adverse Events (TEAEs)Up to Week 52

TEAEs are adverse events that occurred during or after study drug administration. For more details on adverse events please refer the safety section.

Pharmacokinetics: Serum Concentrations by TreatmentBaseline (Week 0), Week 8, 16, 17, 21, 25, 29, 37, and 41

Serum samples were collected at Baseline (Week 0, perdose), approximately 1 week (peak) after IP administration (Weeks 8 and 16), and 2 weeks after dose administration as a trough sample collected prior to the next dose administration (Weeks 17, 21, 25, 29, 37, 41).

Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA) at BaselineBaseline (Week 0)

The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.

Immunogenicity: Number of Participants With ADA at Week 16Week 16

The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.

Immunogenicity: Number of Participants With ADA at Week 25Week 25

The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.

Immunogenicity: Number of Participants With ADA at Week 52 (Completion/Termination Visit)Week 52

The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.

Immunogenicity: Number of Participants With ADA and nADA by Titer at BaselineBaseline (Week 0)

The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.

Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16Week 16

The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.

Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25Week 25

The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.

Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit)Week 52

The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.

Median Time to SeroconversionUp to Week 52

Time to seroconversion (in days) was defined as the time to the observation of the first confirmed positive ADA response. Participants with confirmed positive ADA response at baseline (Week 0 predose) were excluded.

Trial Locations

Locations (84)

DCC Sveti Georgi EOOD

🇧🇬

Haskovo, Bulgaria

The Centre for Dermatology

🇨🇦

Richmond Hill, Ontario, Canada

London Road Diagnostic Clinic and Medical Centre

🇨🇦

Sarnia, Ontario, Canada

Bay State Clinical Trials, Inc

🇺🇸

Watertown, Massachusetts, United States

UMHAT Dr.Georgi Stranski, EAD

🇧🇬

Pleven, Bulgaria

Mediprobe Research Inc

🇨🇦

London, Ontario, Canada

North Bay Dermatology Centre

🇨🇦

North Bay, Ontario, Canada

Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)

🇨🇦

Ste-Foy, Quebec, Canada

Office of Dr. Michael Robern

🇨🇦

Ottawa, Ontario, Canada

Recherche GCP Research

🇨🇦

Montréal, Quebec, Canada

Parnu Hospital

🇪🇪

Pärnu, Estonia

Universitaetsklinikum Schleswig Holstein

🇩🇪

Schleswig, Holstein, Germany

Klinische Forschunq Schwerin GmbH

🇩🇪

Mecklenburg, Vorpommern, Germany

Health Centre 4

🇱🇻

Riga, Latvia

Praxis fuer Dermatologie und Venerologie

🇩🇪

Dresden, Germany

Klinikum der Johann Wolfgang Goethe-Universitaet

🇩🇪

Frankfurt am Main, Germany

Riga 1 st Hospital

🇱🇻

Riga, Latvia

NZOZ POLIMEDICA FILIA KIELCE (Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA)

🇵🇱

Kielce, Poland

Derma Clinic Riga Ltd

🇱🇻

Riga, Latvia

Medica Pro Familia Sp. z o. o. S.K.A. Oddzial w Gdyni

🇵🇱

Gdynia, Poland

Centrum Terapii Wspolczesnej _J.M. Jasnorzewska Sp. Komandytowo-Akcyjna

🇵🇱

Lodz, Poland

NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie

🇵🇱

Lodz, Poland

J. Kisis Ltd

🇱🇻

Riga, Latvia

Ventspils Outpatient Clinic

🇱🇻

Ventspils, Latvia

Medica Pro Familia Sp. z o.o. S.K.A.

🇵🇱

Warsaw, Mazowieckie, Poland

Nzoz Polimedica

🇵🇱

Zgierz, Poland

Pedi-Derma s.r.o.

🇸🇰

Kosice, Kosicky Kraj, Slovakia

Poradnia Kardiologiczna Jaroslaw Jurowiecki

🇵🇱

Gdansk, Poland

MTZ Clinical Research Sp z o.o.

🇵🇱

Warsaw, Poland

Nemocnica Kosice-Saca, a.s., 1.sukromna nemocnica

🇸🇰

Kosice, Slovakia

Sanare S.r.o

🇸🇰

Svidnik, Slovakia

National Clinical Research-Richmond, Inc

🇺🇸

Richmond, Virginia, United States

Encino Research Center

🇺🇸

Encino, California, United States

Wallace Medical Group, Inc.

🇺🇸

Beverly Hills, California, United States

Radiant Research, Inc.

🇺🇸

Greer, South Carolina, United States

Palmetto Clinical Trial Services, LLC

🇺🇸

Fountain Inn, South Carolina, United States

K Papp Clinical Research Inc

🇨🇦

Waterloo, Ontario, Canada

Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem Dermatovenerologicke oddeleni

🇨🇿

Usti nad Labem, Czechia

Vahlberg & Pild OU

🇪🇪

Tallinn, Estonia

Universitaetsklinikum Carl Gustav Carus TU Dresden

🇩🇪

Dresden, Germany

Medicum AS

🇪🇪

Tallinn, Estonia

Tartu University Hospital; Dermatology Clinic

🇪🇪

Tartu, Estonia

Clinical Research Hamburg

🇩🇪

Hamburg, Germany

Medica Pro Familia Sp. z o.o. SK.A.

🇵🇱

Krakow, Poland

Derma therapy spol. s.r.o.

🇸🇰

Bratislava, Slovakia

Department of Dermatology and Venereology, Faculty of Medicine, UMHAT Alexandrovska

🇧🇬

Sofia, Bulgaria

Renstar Medical Research

🇺🇸

Ocala, Florida, United States

Medical Centre Asklepii, OOD

🇧🇬

Dupnitsa, Bulgaria

DCC Sv. Georgi, EOOD

🇧🇬

Plovdiv, Bulgaria

Dermatologie - MUDr. HELENA KORANDOVA s.r.o.

🇨🇿

Olomouc, Povel, Czechia

CCBR Czech Prague s.r.o

🇨🇿

Praha 3, Czech Republic, Czechia

Shahram Jacobs MD, INC

🇺🇸

Sherman Oaks, California, United States

Austin Institute for Clinical Research, LLC

🇺🇸

Pflugerville, Texas, United States

Dr. David Gratton Dermatologue Inc.

🇨🇦

Montreal, Quebec, Canada

Kliiniliste Uuringute Keskus (Clinical Research Centre)

🇪🇪

Tartu, Estonia

CCBR Czech Brno, s.r.o

🇨🇿

Brno, Czechia

Clintrial s.r.o

🇨🇿

Praha 10, Czechia

MUDr. Jaroslav Dragon - Kozni ordinace

🇨🇿

Ústí nad Labem, Czechia

Fakultni nemocnice Kralovske Vinohrady

🇨🇿

Praha 10, Czechia

East Tallinn Central Hospital

🇪🇪

Tallinn, Estonia

North Estonia Medical Centre Foundation

🇪🇪

Tallinn, Estonia

Centrum Medyczne Szpital Swietej Rodziny

🇵🇱

Lodz, Poland

Medicome sp.zoo

🇵🇱

Oswiecim, Poland

Centrum Badan Klinicznych S.C.

🇵🇱

Poznan, Poland

Ai Centrum Medyczne

🇵🇱

Poznan, Poland

KO-MED Centra Kliniczne Pulawy

🇵🇱

Pulawy, Poland

Centrum Medyczne Medyk

🇵🇱

Rzeszow, Poland

KO-MED Centra Kliniczne Zamosc

🇵🇱

Zamosc, Poland

Dema-beauty, s.r.o

🇸🇰

Nitra, Slovakia

Grazyna Pulka Specjalistyczny Osrodek ALL-MED

🇵🇱

Krakow, Poland

KO-MED Centra Kliniczne Lublin II

🇵🇱

Lublin, Poland

NZOZ Nasz Lekarz

🇵🇱

Torun, Poland

CCBR Czech a.s

🇨🇿

Pardubice, Czechia

Horizons Clinical Research Center, LLC

🇺🇸

Denver, Colorado, United States

Bioclinical Research Alliance; Inc

🇺🇸

Miami, Florida, United States

eStudySite

🇺🇸

Las Vegas, Nevada, United States

Sanitas Reasearch, LLC

🇺🇸

Miami, Florida, United States

Compass Research, LLC

🇺🇸

Orlando, Florida, United States

Dawes Fretzin Clinical Research Group, LLC

🇺🇸

Indianapolis, Indiana, United States

Radiant Research; Inc.

🇺🇸

Cincinnati, Ohio, United States

SKDS Research Inc

🇨🇦

Newmarket, Ontario, Canada

Tufts Medical Center; Inc.

🇺🇸

Boston, Massachusetts, United States

Radiant Clinical Research

🇺🇸

Anderson, South Carolina, United States

Clinical Trials of Texas; Inc.

🇺🇸

San Antonio, Texas, United States

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