CompletedPhase 3

Adolescent Mite Allergy Safety Evaluation

Czechia253 participantsStarted 2020-09-23

Plain-language summary

This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis. The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these allergies. The trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents (12-17 years old) in several countries.

Who can participate

Age range12 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent * Male or female subjects aged ≥12 to ≤17 years * A clinical history of allergic rhinitis/rhinoconjunctivitis (AR/C) when exposed to HDM * Positive skin prick test (SPT) to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae at screening * Lung function measured by Forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted value or according to local requirements while on subject's usual asthma medication * The subject must be willing and able to comply with trial protocol and adhere to IMP treatment Main Exclusion Criteria: * A subject who has previously been included in studies with the HDM SLIT-tablet, or otherwise being treated with the marketed HDM SLIT-tablet (e.g. ACARIZAX, ODACTRA) * Any SLIT or SCIT treatment with D. pteronyssinus or D. farinae reaching the maintenance dose within the last 5 years. In addition, any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months prior to visit 1 * Ongoing treatment with any allergy immunotherapy product at screening * Severe chronic oral inflammation * A diagnosis or history of eosinophilic oesophagitis * Any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to first tablet administration * Female with positive urine pregnancy test, breastfeeding, pregnant or planning to become pregnant within the projected duration of the trial …

What they're measuring

Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)

Timeframe: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.

Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)

Timeframe: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.

Number of Treatment-emergent Adverse Events (TEAEs)

Timeframe: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.

Trial details

NCT IDNCT04541004

SponsorALK-Abelló A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-24

Results submitted2021-12-07

View on ClinicalTrials.gov More Allergic Rhinitis trials

Plain-language summary

Who can participate

Age range12 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)

Timeframe: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.

Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)

Timeframe: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.

Number of Treatment-emergent Adverse Events (TEAEs)

Timeframe: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.