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Commitment to safety and efficacy

ALK has a commitment to invest in studying the safety and efficacy of its products. Our R&D department designs and manages our clinical trials in co-operation with university hospitals and allergy specialists. The clinical trials focus on the specific treatment and prevention of allergic disease. For our sublingual immunotherapy (SLIT)-tablets, a global development programme is conducted in collaboration with several partners.

When investigating allergy treatments and indications, we are particularly interested in whether patients’ symptoms and need for symptom-relieving medication have decreased, whether their quality of life has improved, if progression of the disease has slowed down or reversed as well as the overall cost-effectiveness versus existing products.

Our key SLIT-tablet randomised controlled trials

Our SLIT-tablets build on the legacy of subcutaneous immunotherapy, which was discovered in the early 20^th century. In 2002, our SLIT-tablet for grass allergic rhinoconjunctivitis was tested in humans for the first time.

Below we have collected our completed key SLIT-tablet randomised, double-blinded, and placebo-controlled clinical trials investigating the safety and efficacy in grass, tree, ragweed, and house dust mite (HDM) allergic rhinoconjunctivitis, respectively. In addition, two of our completed key HDM SLIT-tablet trials investigated the safety and efficacy in allergic asthma.

Grass SLIT-tablet

GT-08

Disease area: Allergic rhinoconjunctivitis

Phase: III

Follow-up: Long-term (five seasons)

Region: Europe

Age group: Adults

No. of participants: 634

ClinicalTrials: NCT00227279

EudraCT: 2004-000083-27

GT-12

Disease area: Allergic rhinoconjunctivitis

Phase: III

Follow-up: Single-season

Region: Germany

Age group: Children and adolescents

No. of participants: 253

ClinicalTrials: NCT00408616

EudraCT: 2006-003415-46

P05238

Disease area: Allergic rhinoconjunctivitis

Phase: III

Follow-up: Single-season

Region: North America

Age group: Adults

No. of participants: 439

ClinicalTrials: NCT00562159

P05239

Disease area: Allergic rhinoconjunctivitis

Phase: III

Follow-up: Single-season

Region: North America

Age group: Children and adolescents

No. of participants: 345

ClinicalTrials: NCT00550550

P08067

Disease area: Allergic rhinoconjunctivitis

Phase: III

Follow-up: Single-season

Region: North America

Age group: Children, adolescents, and adults

No. of participants: 1,501

ClinicalTrials: NCT01385371

GT-21/GAP

Disease area: Allergic rhinoconjunctivitis

Phase: III

Follow-up: Long-term (five seasons)

Region: Europe

Age group: Children and adolescents

No. of participants: 812

ClinicalTrials: NCT01061203

EudraCT: 2009-011235-12

Tree SLIT-tablet

TT-03

Disease area: Allergic rhinoconjunctivitis

Phase: II

Follow-up: 24 weeks

Region: Environmental exposure chamber (Europe)

Age group: Adults

No. of participants: 219

ClinicalTrials: NCT02481856

TT-04

Disease area: Allergic rhinoconjunctivitis

Phase: III

Follow-up: Single-season

Region: Europe

Age group: Adolescents and adults

No. of participants: 634

EudraCT: 2015-004821-15

Ragweed SLIT-tablet

P05233

Disease area: Allergic rhinoconjunctivitis

Phase: II/III

Follow-up: One year

Region: North America

Age group: Adults

No. of participants: 565

ClinicalTrials: NCT00783198

P05234

Disease area: Allergic rhinoconjunctivitis

Phase: II/III

Follow-up: One year

Region: North America and Europe

Age group: Adults

No. of participants: 784

ClinicalTrials: NCT00770315

EudraCT: 2008-003864-20

P008

Disease area: Allergic rhinoconjunctivitis

Phase: III

Follow-up: Single-season

Region: North America and Europe

Age group: Children and adolescents

No. of participants: 1,025

ClinicalTrials: NCT02478398

EudraCT: 2014-004341-27

HDM SLIT-tablet

MT-02

Disease area: Allergic rhinoconjunctivitis and allergic asthma

Phase: II/III

Follow-up: One year

Region: Europe

Age group: Adolescents and adults

No. of participants: 604

ClinicalTrials: NCT00389363

EudraCT: 2006-001795-20

MT-04/MITRA

Disease area: Allergic asthma

Phase: III

Follow-up: Up to 78 weeks

Region: Europe

Age group: Adults

No. of participants: 834

ClinicalTrials: NCT01433523

EudraCT: 2010-018621-19

MT-06/MERIT

Disease area: Allergic rhinoconjunctivitis

Phase: III

Follow-up: One year

Region: Europe

Age group: Adults

No. of participants: 992

ClinicalTrials: NCT01454544

EudraCT: 2011-002277-38

P003

Disease area: Allergic rhinoconjunctivitis

Phase: II

Follow-up: Up to 76 weeks

Region: Environmental exposure chamber (Europe)

Age group: Adults

No. of participants: 124

ClinicalTrials: NCT01644617

EudraCT: 2012-001855-38

TO-203-3-2

Disease area: Allergic rhinoconjunctivitis

Phase: III

Follow-up: One year

Region: Japan

Age group: Adolescents and adults

No. of participants: 946

JapicCTI: 121848 (ENG)

P001

Disease area: Allergic rhinoconjunctivitis

Phase: III

Follow-up: One year

Region: North America

Age group: Adolescents and adults

No. of participants: 1,482

Compliance with guidelines

In compliance with industry guidelines, more information about all our clinical trials can be found via the freely public registries ClinicalTrials.gov and EudraCT as well as on the page Clinical data sharing.