MedPath

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Phase 3
Completed
Conditions
Chronic Plaque Psoriasis
Moderate to Severe Chronic Plaque Psoriasis
Interventions
Registration Number
NCT03598790
Lead Sponsor
UCB Biopharma SRL
Brief Summary

This is a study to evaluate the long-term safety and tolerability of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis (PSO).

Detailed Description

The study consists of a 144-week Treatment Period (open-label) and an optional 48-week Open-Label Extension Period 2 (OLE2) for eligible subjects in the USA and Canada.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1353
Inclusion Criteria

Treatment Period (open-label)

  • Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator

  • Subject completes the feeder study (PS0008 [NCT03412747], PS0009 [NCT03370133], PS0013 [NCT03410992]) without meeting any withdrawal criteria

  • Female subjects must be:

    1. Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause
    2. Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)
    3. Or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception throughout the duration of the study until 20 weeks after last administration of investigational medicinal product (IMP), and have a negative pregnancy test at the feeder study in final visit/Baseline visit in PS0014

OLE2 Period (USA and Canada)

  • Completed the OLE Period without meeting any withdrawal criteria
  • Compliant with ongoing clinical study requirements
  • Female subject of childbearing potential must be willing to use highly effective method of contraception
  • Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only)
  • Signed a separate OLE2 Period ICF
Exclusion Criteria

Treatment Period (open-label)

  • Subject has previously participated in this study
  • Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication
  • Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study. Note: For any subject with an ongoing Serious Adverse Event (SAE), or a history of serious infections in the feeder study, the Medical Monitor must be consulted prior to the subject's entry into PS0014, although the decision on whether to enroll the subject remains with the Investigator
  • Subject has a positive or indeterminate interferon gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
  • Subject may not participate in another study of a medicinal product or device under investigation other than the substudy
  • Subject has a history of chronic alcohol or drug abuse within 6 months prior to Baseline as assessed by medical history, site interview, and/or results of the specified urine drug screen

OLE2 Period (USA and Canada)

  • Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period
  • Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated
  • Presence of active suicidal ideation or severe depression
  • Subject has developed any active malignancy or history of malignancy prior to the OLE2 Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Bimekizumab dose regimen 2BimekizumabSubjects are randomized to receive BKZ 2 during the 144-week Treatment Period (open-label). Eligible subjects who completed the Treatment Period (open-label), would continue OLE2 on BKZ 2. Intervention Name: Bimekizumab
Bimekizumab dose regimen 1BimekizumabSubjects are randomized to receive either dose regimen 1 (BKZ 1) or dose regimen 2 (BKZ 2) during the 144-week Treatment Period (open-label), those on BKZ 1 will switch to BKZ 2 at Week 24 or later (at the next scheduled clinic visit after Week 48) Eligible subjects who completed the Treatment Period (open-label), and have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks. Intervention Name: Bimekizumab
Primary Outcome Measures
NameTimeMethod
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP)From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period

The number of TEAEs adjusted by duration of exposure to study treatment were scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.

Secondary Outcome Measures
NameTimeMethod
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMPFrom Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period

The number of SAEs adjusted by duration of exposure to study treatment were scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk is used.

Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to IMPFrom Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period

The number of TEAEs leading to withdrawal adjusted by duration of exposure to study treatment were scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.

Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Non-responder Imputation)Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B

The PASI90 response assessments were based on improvement (reduction) of at least 90% in the PASI score compared to Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Observed Case)Week 144 compared to Baseline of PS0014 for Cohort B

PASI90 response assessments were based on improvement (reduction) of at least 90% in the PASI score compared to Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of person's affected skin for respective section. Minimum score is 0= no disease, maximum score is 72= maximal disease.

InvestigatorĀ“s Global Assessment (IGA) 0/1 Response at Week 144 (Non-responder Imputation)Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B

The Investigator assessed the overall severity of psoriasis using the following 5-point scale: 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present); 1= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling); 2= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling); 3= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling); 4= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). IGA response -IGA score of clear \[0\] or almost clear \[1\] with at least two category improvement from Baseline at visit timepoint.

InvestigatorĀ“s Global Assessment (IGA) 0/1 Response at Week 144 (Observed Case)Week 144 for Cohort B EP and GPP groups

The Investigator assessed the overall severity of psoriasis using the following 5-point scale: 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present); 1= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling); 2= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling); 3= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling); 4= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). IGA response -IGA score of 0 or 1 at Week 144.

Trial Locations

Locations (189)

Ps0014 956

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Verona, New Jersey, United States

Ps0014 951

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Webster, Texas, United States

Ps0014 659

šŸ‡ØšŸ‡¦

Calgary, Canada

Ps0014 664

šŸ‡ØšŸ‡¦

Toronto, Canada

PS0014 8

šŸ‡¦šŸ‡ŗ

East Melbourne, Australia

Ps0014 927

šŸ‡ŗšŸ‡ø

Los Angeles, California, United States

Ps0014 922

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Baton Rouge, Louisiana, United States

Ps0014 957

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Glendale, Arizona, United States

Ps0014 909

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Boynton Beach, Florida, United States

Ps0014 941

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Alpharetta, Georgia, United States

Ps0014 917

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Troy, Michigan, United States

Ps0014 910

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Bakersfield, California, United States

Ps0014 943

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San Luis Obispo, California, United States

Ps0014 912

šŸ‡ŗšŸ‡ø

Coral Gables, Florida, United States

Ps0014 900

šŸ‡ŗšŸ‡ø

West Des Moines, Iowa, United States

Ps0014 940

šŸ‡ŗšŸ‡ø

Beverly, Massachusetts, United States

PS0014 7

šŸ‡¦šŸ‡ŗ

Campbelltown, Australia

Ps0014 673

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Halifax, Canada

Ps0014 945

šŸ‡ŗšŸ‡ø

Greer, South Carolina, United States

Ps0014 947

šŸ‡ŗšŸ‡ø

Buffalo, New York, United States

PS0014 5

šŸ‡¦šŸ‡ŗ

Phillip, Australia

Ps0014 903

šŸ‡ŗšŸ‡ø

Ocala, Florida, United States

Ps0014 901

šŸ‡ŗšŸ‡ø

Portsmouth, New Hampshire, United States

Ps0014 908

šŸ‡ŗšŸ‡ø

East Windsor, New Jersey, United States

Ps0014 925

šŸ‡ŗšŸ‡ø

Brighton, Massachusetts, United States

PS0014 3

šŸ‡¦šŸ‡ŗ

Carlton, Australia

Ps0014 954

šŸ‡ŗšŸ‡ø

Skokie, Illinois, United States

Ps0014 931

šŸ‡ŗšŸ‡ø

Dallas, Texas, United States

Ps0014 50

šŸ‡§šŸ‡Ŗ

Bruxelles, Belgium

Ps0014 937

šŸ‡ŗšŸ‡ø

Johnston, Rhode Island, United States

Ps0014 213

šŸ‡©šŸ‡Ŗ

Mahlow, Germany

Ps0014 652

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Oakville, Canada

Ps0014 209

šŸ‡©šŸ‡Ŗ

Darmstadt, Germany

Ps0014 51

šŸ‡§šŸ‡Ŗ

Charleroi, Belgium

Ps0014 963

šŸ‡ŗšŸ‡ø

Rochester, New York, United States

PS0014 9

šŸ‡¦šŸ‡ŗ

Woolloongabba, Australia

PS0014 4

šŸ‡¦šŸ‡ŗ

Fremantle, Australia

Ps0014 668

šŸ‡ØšŸ‡¦

North Bay, Canada

Ps0014 300

šŸ‡®šŸ‡¹

Roma, Italy

Ps0014 621

šŸ‡ÆšŸ‡µ

Nagoya, Japan

Ps0014 629

šŸ‡ÆšŸ‡µ

Asahikawa, Japan

Ps0014 705

šŸ‡°šŸ‡·

Seongnam-si, Korea, Republic of

Ps0014 605

šŸ‡ÆšŸ‡µ

Bunkyo-ku, Japan

Ps0014 355

šŸ‡µšŸ‡±

Bialystok, Poland

Ps0014 400

šŸ‡·šŸ‡ŗ

Moscow, Russian Federation

Ps0014 702

šŸ‡°šŸ‡·

Gwangju, Korea, Republic of

Ps0014 601

šŸ‡ÆšŸ‡µ

Fukuoka, Japan

Ps0014 369

šŸ‡µšŸ‡±

Bialystok, Poland

Ps0014 608

šŸ‡ÆšŸ‡µ

Itabashi-ku, Japan

Ps0014 609

šŸ‡ÆšŸ‡µ

Kobe, Japan

Ps0014 623

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Morioka, Japan

Ps0014 701

šŸ‡°šŸ‡·

Busan, Korea, Republic of

Ps0014 402

šŸ‡·šŸ‡ŗ

Moscow, Russian Federation

Ps0014 619

šŸ‡ÆšŸ‡µ

Gifu, Japan

Ps0014 700

šŸ‡°šŸ‡·

Seoul, Korea, Republic of

Ps0014 303

šŸ‡®šŸ‡¹

Roma, Italy

Ps0014 617

šŸ‡ÆšŸ‡µ

Sendai, Japan

Ps0014 372

šŸ‡µšŸ‡±

Lodz, Poland

Ps0014 604

šŸ‡ÆšŸ‡µ

Minato-ku, Japan

Ps0014 403

šŸ‡·šŸ‡ŗ

Moscow, Russian Federation

Ps0014 371

šŸ‡µšŸ‡±

Bydgoszcz, Poland

Ps0014 554

šŸ‡¬šŸ‡§

Reading, United Kingdom

Ps0014 550

šŸ‡¬šŸ‡§

Manchester, United Kingdom

Ps0014 405

šŸ‡·šŸ‡ŗ

Saint Petersburg, Russian Federation

Ps0014 555

šŸ‡¬šŸ‡§

Salford, United Kingdom

Ps0014 552

šŸ‡¬šŸ‡§

Liverpool, United Kingdom

Ps0014 905

šŸ‡ŗšŸ‡ø

Overland Park, Kansas, United States

Ps0014 672

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Edmonton, Canada

Ps0014 671

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Hamilton, Canada

Ps0014 675

šŸ‡ØšŸ‡¦

Markham, Canada

Ps0014 667

šŸ‡ØšŸ‡¦

Ottawa, Canada

Ps0014 661

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Peterborough, Canada

Ps0014 665

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Quebec City, Canada

Ps0014 676

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Surrey, Canada

Ps0014 616

šŸ‡ÆšŸ‡µ

TSU, Japan

Ps0014 610

šŸ‡ÆšŸ‡µ

Chuo-ku, Japan

Ps0014 620

šŸ‡ÆšŸ‡µ

Hamamatsu, Japan

Ps0014 600

šŸ‡ÆšŸ‡µ

Kurume, Japan

Ps0014 625

šŸ‡ÆšŸ‡µ

Nankoku, Japan

Ps0014 624

šŸ‡ÆšŸ‡µ

Obihiro, Japan

Ps0014 622

šŸ‡ÆšŸ‡µ

Matsumoto, Japan

Ps0014 613

šŸ‡ÆšŸ‡µ

Shimotsuke, Japan

Ps0014 611

šŸ‡ÆšŸ‡µ

Osaka, Japan

Ps0014 614

šŸ‡ÆšŸ‡µ

Osaka, Japan

Ps0014 612

šŸ‡ÆšŸ‡µ

Shinjuku-ku, Japan

Ps0014 618

šŸ‡ÆšŸ‡µ

Shinjuku-ku, Japan

Ps0014 628

šŸ‡ÆšŸ‡µ

Shinjuku-ku, Japan

Ps0014 606

šŸ‡ÆšŸ‡µ

Takaoka, Japan

Ps0014 626

šŸ‡ÆšŸ‡µ

Shinjuku-ku, Japan

Ps0014 615

šŸ‡ÆšŸ‡µ

Tokyo, Japan

Ps0014 627

šŸ‡ÆšŸ‡µ

Tokyo, Japan

PS0014 2

šŸ‡¦šŸ‡ŗ

Westmead, Australia

Ps0014 10

šŸ‡¦šŸ‡ŗ

Kogarah, Australia

PS0014 6

šŸ‡¦šŸ‡ŗ

Kogarah, Australia

Ps0014 928

šŸ‡ŗšŸ‡ø

Fort Myers, Florida, United States

Ps0014 603

šŸ‡ÆšŸ‡µ

Sapporo, Japan

Ps0014 653

šŸ‡ØšŸ‡¦

Toronto, Canada

Ps0014 252

šŸ‡­šŸ‡ŗ

Budapest, Hungary

Ps0014 262

šŸ‡­šŸ‡ŗ

Encs, Hungary

Ps0014 934

šŸ‡ŗšŸ‡ø

Washington, District of Columbia, United States

Ps0014 967

šŸ‡ŗšŸ‡ø

Santa Monica, California, United States

Ps0014 921

šŸ‡ŗšŸ‡ø

Ormond Beach, Florida, United States

Ps0014 906

šŸ‡ŗšŸ‡ø

Hollywood, Florida, United States

Ps0014 911

šŸ‡ŗšŸ‡ø

Plainfield, Indiana, United States

Ps0014 915

šŸ‡ŗšŸ‡ø

Clayton, Missouri, United States

Ps0014 944

šŸ‡ŗšŸ‡ø

New Orleans, Louisiana, United States

Ps0014 962

šŸ‡ŗšŸ‡ø

Owensboro, Kentucky, United States

Ps0014 958

šŸ‡ŗšŸ‡ø

Omaha, Nebraska, United States

Ps0014 920

šŸ‡ŗšŸ‡ø

Portland, Oregon, United States

Ps0014 965

šŸ‡ŗšŸ‡ø

Kew Gardens, New York, United States

Ps0014 961

šŸ‡ŗšŸ‡ø

Rocky Mount, North Carolina, United States

Ps0014 913

šŸ‡ŗšŸ‡ø

New York, New York, United States

Ps0014 933

šŸ‡ŗšŸ‡ø

Murray, Utah, United States

Ps0014 52

šŸ‡§šŸ‡Ŗ

LiĆØge, Belgium

Ps0014 658

šŸ‡ØšŸ‡¦

Ajax, Canada

Ps0014 660

šŸ‡ØšŸ‡¦

Montreal, Canada

Ps0014 663

šŸ‡ØšŸ‡¦

Mississauga, Canada

Ps0014 650

šŸ‡ØšŸ‡¦

Surrey, Canada

Ps0014 651

šŸ‡ØšŸ‡¦

Richmond Hill, Canada

Ps0014 670

šŸ‡ØšŸ‡¦

Windsor, Canada

Ps0014 662

šŸ‡ØšŸ‡¦

Toronto, Canada

Ps0014 669

šŸ‡ØšŸ‡¦

Windsor, Canada

Ps0014 657

šŸ‡ØšŸ‡¦

Waterloo, Canada

Ps0014 217

šŸ‡©šŸ‡Ŗ

Schweinfurt, Germany

Ps0014 203

šŸ‡©šŸ‡Ŗ

Dresden, Germany

Ps0014 207

šŸ‡©šŸ‡Ŗ

Berlin, Germany

Ps0014 218

šŸ‡©šŸ‡Ŗ

Bonn, Germany

Ps0014 208

šŸ‡©šŸ‡Ŗ

Frankfurt, Germany

Ps0014 214

šŸ‡©šŸ‡Ŗ

Erlangen, Germany

Ps0014 202

šŸ‡©šŸ‡Ŗ

Hamburg, Germany

Ps0014 211

šŸ‡©šŸ‡Ŗ

Hamburg, Germany

Ps0014 220

šŸ‡©šŸ‡Ŗ

Hamburg, Germany

Ps0014 210

šŸ‡©šŸ‡Ŗ

Friedrichshafen, Germany

Ps0014 255

šŸ‡­šŸ‡ŗ

Budapest, Hungary

Ps0014 215

šŸ‡©šŸ‡Ŗ

LĆ¼beck, Germany

Ps0014 212

šŸ‡©šŸ‡Ŗ

Heidelberg, Germany

Ps0014 219

šŸ‡©šŸ‡Ŗ

MĆ¼nster, Germany

Ps0014 205

šŸ‡©šŸ‡Ŗ

OsnabrĆ¼ck, Germany

Ps0014 200

šŸ‡©šŸ‡Ŗ

Schwerin, Germany

Ps0014 253

šŸ‡­šŸ‡ŗ

OroshƔza, Hungary

Ps0014 204

šŸ‡©šŸ‡Ŗ

Witten, Germany

Ps0014 254

šŸ‡­šŸ‡ŗ

Budapest, Hungary

Ps0014 256

šŸ‡­šŸ‡ŗ

Debrecen, Hungary

Ps0014 261

šŸ‡­šŸ‡ŗ

Budapest, Hungary

Ps0014 260

šŸ‡­šŸ‡ŗ

Szeged, Hungary

Ps0014 251

šŸ‡­šŸ‡ŗ

Gyula, Hungary

Ps0014 259

šŸ‡­šŸ‡ŗ

SzekszƔrd, Hungary

Ps0014 250

šŸ‡­šŸ‡ŗ

Szolnok, Hungary

Ps0014 258

šŸ‡­šŸ‡ŗ

VeszprƩm, Hungary

Ps0014 607

šŸ‡ÆšŸ‡µ

Chiyoda-ku, Japan

Ps0014 602

šŸ‡ÆšŸ‡µ

Shinagawa-ku, Japan

Ps0014 703

šŸ‡°šŸ‡·

Seoul, Korea, Republic of

Ps0014 362

šŸ‡µšŸ‡±

Bialystok, Poland

Ps0014 350

šŸ‡µšŸ‡±

Warszawa, Poland

Ps0014 365

šŸ‡µšŸ‡±

Wroclaw, Poland

Ps0014 401

šŸ‡·šŸ‡ŗ

Saratov, Russian Federation

Ps0014 754

šŸ‡ØšŸ‡³

Taipei, Taiwan

Ps0014 404

šŸ‡·šŸ‡ŗ

St. Petersburg, Russian Federation

Ps0014 406

šŸ‡·šŸ‡ŗ

Yaroslavl, Russian Federation

Ps0014 755

šŸ‡ØšŸ‡³

Taipei, Taiwan

Ps0014 551

šŸ‡¬šŸ‡§

Dundee, United Kingdom

Ps0014 674

šŸ‡ØšŸ‡¦

Winnipeg, Canada

Ps0014 353

šŸ‡µšŸ‡±

Szczecin, Poland

Ps0014 367

šŸ‡µšŸ‡±

Wroclaw, Poland

Ps0014 352

šŸ‡µšŸ‡±

Gdansk, Poland

Ps0014 359

šŸ‡µšŸ‡±

Katowice, Poland

Ps0014 357

šŸ‡µšŸ‡±

Kielce, Poland

Ps0014 360

šŸ‡µšŸ‡±

Lodz, Poland

Ps0014 351

šŸ‡µšŸ‡±

Warszawa, Poland

Ps0014 366

šŸ‡µšŸ‡±

Katowice, Poland

Ps0014 363

šŸ‡µšŸ‡±

Krakow, Poland

Ps0014 368

šŸ‡µšŸ‡±

Wroclaw, Poland

Ps0014 373

šŸ‡µšŸ‡±

Wroclaw, Poland

Ps0014 356

šŸ‡µšŸ‡±

Lublin, Poland

Ps0014 361

šŸ‡µšŸ‡±

Bialystok, Poland

Ps0014 358

šŸ‡µšŸ‡±

Katowice, Poland

Ps0014 374

šŸ‡µšŸ‡±

Poznan, Poland

Ps0014 354

šŸ‡µšŸ‡±

Warszawa, Poland

Ps0014 370

šŸ‡µšŸ‡±

Wroclaw, Poland

Ps0014 364

šŸ‡µšŸ‡±

Nowa Sol, Poland

Ps0014 919

šŸ‡ŗšŸ‡ø

San Diego, California, United States

Ps0014 936

šŸ‡ŗšŸ‡ø

Tampa, Florida, United States

Ps0014 946

šŸ‡ŗšŸ‡ø

Phoenix, Arizona, United States

Ps0014 924

šŸ‡ŗšŸ‡ø

Houston, Texas, United States

Ps0014 914

šŸ‡ŗšŸ‡ø

San Antonio, Texas, United States

Ps0014 955

šŸ‡ŗšŸ‡ø

San Diego, California, United States

Ps0014 907

šŸ‡ŗšŸ‡ø

Miami, Florida, United States

Ps0014 932

šŸ‡ŗšŸ‡ø

Oklahoma City, Oklahoma, United States

Ps0014 929

šŸ‡ŗšŸ‡ø

Portland, Oregon, United States

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